HIV Infections
Conditions
Keywords
GSK3640254, ethinyl estradiol, levonorgestrel, oral contraceptive, drug-drug interaction
Brief summary
This is an open-label, single-sequence, 1-way drug-drug interaction study to investigate the effect of GSK3640254 on the pharmacokinetics of a combination oral contraceptive containing ethinyl estradiol (EE) and levonorgestrel (LNG). Effective contraception for women infected with human immunodeficiency virus (HIV) is important in the prevention of unplanned pregnancies. The study will consist of a screening period of 28 days, check-in (Day -4), a run-in period and a treatment period. During the run-in period, subjects will be administered Portia® (0.03 milligrams \[mg\] EE/0.15 mg LNG) once daily on Days -3 to -1. Subjects will then be administered Portia once daily on Days 1 to 10 of treatment period A followed by administration of Portia once daily along with GSK3640254 200 mg on Days 11 to 21 of treatment period B. The duration of the study is approximately 8 weeks, including Screening and Run-in. Portia is a registered trademark of Teva Pharmaceuticals USA.
Interventions
DRUGGSK3640254
GSK3640254 will be available as a 100 mg capsule. Subjects will be administered 200 mg GSK3640254 once daily via the oral route on Days 11 to 21.
DRUGPortia
Portia will be available in the form of tablets containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel.
Sponsors
ViiV Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject must be 18 to 50 years of age inclusive, at the time of signing the informed consent. * Subjects who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG). * Body weight \>=45.0 kilograms (kg) (99 pounds \[lbs\]) and body mass index (BMI) within the range 18.5 to 31.0 kilograms per meter square (kg/m\^2) (inclusive). * Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Female subjects will be included. * Subject must not be pregnant or breastfeeding. * Subject is a woman of childbearing potential (WOCBP) with intact ovarian function, as determined by medical history. Subjects must use Portia for the duration of the run-in and treatment periods. * WOCBP must have been on an acceptable form of contraceptive for at least 28 days prior to start of study intervention. Acceptable forms of contraception prior to study intervention include the following: Intrauterine device or intrauterine system; Combined estrogen and progestogen oral contraceptive; Contraceptive vaginal ring; Percutaneous contraceptive patches (if used, the patch must be removed during study participation); Bilateral tubal occlusion; Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. The documentation on male sterility can come from the site personnel's review of subject's medical records, medical examination and/or semen analysis, or medical history interview provided by her or her partner.; Sexual abstinence. * Subjects who have been on a stable regimen of an oral contraceptive for at least 3 consecutive months must be without evidence of breakthrough bleeding or spotting. * Subjects who have been taking oral contraceptives should continue their current regimen until check-in to the clinic for the run-in period. Subjects not currently taking an oral contraceptive are eligible, provided all other eligibility criteria are met. * Subjects may proceed to the treatment period provided the toxicity profile during the run-in period with Portia is acceptable in the opinion of the investigator. * Subjects must agree to use an additional method of contraception from the following list of contraceptive methods for the run-in period, treatment period, and for 28 days after the last dose of study intervention: Non hormonal Intrauterine device; Bilateral tubal occlusion; Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. The documentation on male sterility can come from the site personnel's review of subject's medical records, medical examination and/or semen analysis, or medical history interview provided by her or her partner.; Sexual abstinence. For the 28 days after study exit, women may resume oral contraceptives but double barrier methods (a combination of male condom with either cervical cap, diaphragm, or sponge with spermicide) must be used in addition. * Women of childbearing potential must have a negative highly sensitive serum pregnancy test on Day -4 and Day -1. * Additional requirements for pregnancy testing during and after study intervention as outlined in protocol. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and protocol.
Exclusion criteria
* History of jaundice associated with taking oral contraceptives or with pregnancy. * History of clinically significant irregular bleeding while taking oral contraceptives. * History of past deep venous thrombosis, pulmonary embolism, stroke, transient ischemic attack, phlebitis, or migraine headaches with prolonged aura. * History of cerebrovascular or coronary artery disease. * History of retinal vascular lesions. * History of carcinoma of the breast, endometrium, or other known estrogen-dependent neoplasia. * Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * A pre-existing condition interfering with normal gastrointestinal (GI) anatomy or motility (e.g., gastroesophageal reflux disease, gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs or render the subject unable to take oral study intervention. * Any history of significant underlying psychiatric disorder, including, but not limited to, schizophrenia, bipolar disorder with or without psychotic symptoms, other psychotic disorders, or schizotypal (personality) disorder. * Any history of major depressive disorder with or without suicidal features, or anxiety disorders that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (\>6 months) outpatient treatment. Subjects with other conditions such as adjustment disorder or dysthymia that have required shorter term medical therapy (\<6 months) without inpatient treatment and are currently well-controlled clinically or resolved may be considered for entry after discussion and agreement with the ViiV Healthcare/GlaxoSmithKline (GSK) Medical Monitor. * Any pre-existing physical or other psychiatric condition (including alcohol or drug abuse), which, in the opinion of the investigator (with or without psychiatric evaluation), could interfere with the subject's ability to comply with the dosing schedule and protocol evaluations or which might compromise the safety of the subject. * Medical history of cardiac arrhythmias, prior myocardial infarction in the past 3 months, or cardiac disease or a family or personal history of long QT syndrome. * Presence of hepatitis B surface antigen at Screening or within 3 months prior to starting study intervention. * Positive hepatitis C antibody test result at Screening or within 3 months prior to starting study intervention AND positive on reflex to hepatitis C ribonucleic acid (RNA). * Positive HIV-1 and -2 antigen/antibody immunoassay at Screening. * ALT \>1.5 times upper limit of normal (ULN). A single repeat of ALT is allowed within a single screening period to determine eligibility. * Bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Any acute laboratory abnormality at Screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound. * Any Grade 2 to 4 laboratory abnormality at Screening, with the exception of creatine phosphokinase (CPK) and lipid abnormalities (e.g., total cholesterol, triglycerides, etc), and ALT (described above), will exclude a subject from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the sponsor. A single repeat of any laboratory abnormality is allowed within a single screening period to determine eligibility. * A positive test result for drugs of abuse (including marijuana), alcohol, or cotinine (indicating active current smoking) at Screening or before the first dose of study intervention. * Unable to refrain from the use of prescription or nonprescription drugs including vitamins, herbal and dietary supplements (including St John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study intervention and for the duration of the study (acetaminophen/paracetamol at doses of \<=2 grams/day and hydrocortisone cream 1% are permitted for use any time during the study). * Treatment with any vaccine within 30 days prior to receiving study intervention. * Unwillingness to abstain from excessive consumption of any food or drink containing grapefruit and grapefruit juice, Seville oranges, blood oranges, or pomelos or their fruit juices within 7 days prior to the first dose of study intervention(s) until the end of the study. * Participation in another concurrent clinical study or prior clinical study (with the exception of imaging trials) prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). * Where participation in the study would result in donation of blood or blood products in excess of 500 milliliters (mL) within 56 days. * Any positive (abnormal) response confirmed by the investigator on a screening clinician- or qualified designee-administered Columbia Suicide Severity Rating Scale (C-SSRS). * Any significant arrhythmia or ECG finding (e.g., symptomatic bradycardia, non-sustained or sustained atrial arrhythmias, non-sustained or sustained ventricular tachycardia, second-degree atrioventricular block Mobitz Type II, or third-degree atrioventricular block) which, in the opinion of the investigator or ViiV Healthcare/GSK Medical Monitor, will interfere with the safety for the individual subject. *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Period 2: AUC (0-tau) of EE | Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 and 24 hours post dose | Blood samples were collected at indicated time points for the analysis of AUC (0-tau) of EE. PK parameters were calculated by standard non-compartmental analysis. |
| Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing Interval at Steady State (AUC [0-tau]) of EE | Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours | Blood samples were collected at indicated time points for the analysis of AUC (0-tau) of EE. PK parameters were calculated by standard non-compartmental analysis. The PK population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated. |
| Period 1:AUC (0-tau) of LNG | Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours | Blood samples were collected at indicated time points for the analysis of AUC (0-tau) of LNG. PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: AUC (0-tau) of LNG | Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 and 24 hours post dose | Blood samples were collected at indicated time points for the analysis of AUC (0-tau) of LNG. PK parameters were calculated by standard non-compartmental analysis. |
| Period 1: Maximum Observed Concentration (Cmax) and Plasma Concentration at the End of the Dosing Interval (Ctau) of EE | Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours | Blood samples were collected at indicated time points for the analysis of Cmax and Ctau of EE. PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: Cmax and Ctau of EE | Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 and 24 hours | Blood samples were collected at indicated time points for the analysis of Cmax and Ctau of EE. PK parameters were calculated by standard non-compartmental analysis. |
| Period 1:Cmax and Ctau of LNG | Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours | Blood samples were collected at indicated time points for the analysis of Cmax and Ctau of LNG. PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: Cmax and Ctau of LNG | Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 and 24 hours post dose | Blood samples were collected at indicated time points for the analysis of Cmax and Ctau of LNG. PK parameters were calculated by standard non-compartmental analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Period 1: t1/2 of EE | Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours | Blood samples were collected at indicated time points for the analysis of t1/2 of EE. PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: t1/2 of EE | Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 22: 24 hours; Day 23: 48 hours and Day 24: 72 hours | Blood samples were collected at indicated time points for the analysis of t1/2 of EE. PK parameters were calculated by standard non-compartmental analysis. |
| Period 1: Tmax of EE | Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours | Blood samples were collected at indicated time points for the analysis of Tmax of EE. PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: Tmax of EE | Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 22: 24 hours; Day 23: 48 hours and Day 24: 72 hours | Blood samples were collected at indicated time points for the analysis of Tmax of EE. PK parameters were calculated by standard non-compartmental analysis. |
| Period 1: t1/2 of LNG | Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours | Blood samples were collected at indicated time points for the analysis of t1/2 of LNG. PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: t1/2 of LNG | Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours; Day 22: 24 hours; Day 23: 48 hours and Day 24: 72 hours | Blood samples were collected at indicated time points for the analysis of t1/2 of LNG. PK parameters were calculated by standard non-compartmental analysis. |
| Period 1: Tmax of LNG | Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours | Blood samples were collected at indicated time points for the analysis of Tmax of LNG. PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: Tmax of LNG | Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours; Day 22: 24 hours; Day 23: 48 hours and Day 24: 72 hours | Blood samples were collected at indicated time points for the analysis of Tmax of LNG. PK parameters were calculated by standard non-compartmental analysis. |
| Period 1: Change From Baseline in Pulse Rate | Baseline (Day 1, Pre-dose) and at Day 10 | Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as the average of the triplicate predose assessments. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE) (Treatment Period) | Up to Day 25 | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. Safety Population comprised of all participants who received at least one dose of study medication. |
| Number of Participants With Non-SAEs and SAE (Run-in Period) | From Day -3 to Day -1 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. |
| Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and BUN. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and BUN. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma albumin, globulin and protein. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma albumin, globulin and protein. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Amylase and Lipase | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma amylase and lipase. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Amylase and Lipase | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma amylase and lipase. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Plasma creatine kinase, lactate dehydrogenase, ALT, ALP, AST and GGT. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Plasma creatine kinase, lactate dehydrogenase, ALT, ALP, AST and GGT. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Plasma urate, creatinine, total bilirubin and direct bilirubin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Plasma urate, creatinine, total bilirubin and direct bilirubin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of hematology parameters including Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of hematology parameters including Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular volume. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular volume. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 1: Change From Baseline in Urine Concentration: Urine Urobilinogen | Baseline (Day 1, Pre-dose) and at Day 10 | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 1: Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 2: Change From Baseline in Hematology Parameter: Erythrocytes | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 1: Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of hematology parameter hematocrit. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 2: Change From Baseline in Hematology Parameter: Hematocrit | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of hematology parameter hematocrit. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 1: Change From Baseline in Hematology Parameter: Hemoglobin | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of hematology parameter hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 2: Change From Baseline in Hematology Parameter: Hemoglobin | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of hematology parameter hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 1: Change From Baseline in Urine Concentration: Urine Specific Gravity | Baseline (Day 1, Pre-dose) and at Day 10 | Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 2: Change From Baseline in Urine Concentration: Urine Specific Gravity | Baseline (Day 10) and at Days 21 and 24 | Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 2: Change From Baseline in Urine Concentration: Urine Urobilinogen | Baseline (Day 10) and at Days 21 and 24 | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 1: Change From Baseline in Urine Concentration: Urine Potential of Hydrogen (pH) | Baseline (Day 1, Pre-dose) and at Day 10 | Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 2: Change From Baseline in Urine Concentration: Urine pH | Baseline (Day 10) and at Days 21 and 24 | Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 1: Change From Baseline in Electrocardiogram (ECG) Mean Heart Rate | Baseline (Day 1, Pre-dose) and at Day 10 | Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 2: Change From Baseline in ECG Mean Heart Rate | Baseline (Day 11, Pre-dose) and at Day 11: 2, 4, 6 hours, Day 15: 2, 4, 6 hours, Day 21 and 24 | Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline is defined as the average of the triplicate predose assessments on Day 11. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval | Baseline (Day 1, Pre-dose) and at Day 10 | Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | Baseline (Day 11, Pre-dose) and at Day 11: 2, 4, 6 hours, Day 15: 2, 4, 6 hours, Day 21 and 24 | Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline is defined as the average of the triplicate predose assessments on Day 11. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 1: Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Day 1, Pre-dose) and at Day 10 | SBP and DBP were assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as the average of the triplicate pre-dose assessments. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 2: Change From Baseline in Vital Signs: SBP and DBP | Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24 | SBP and DBP were assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as as the average of the triplicate pre-dose assessments. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 2: Change From Baseline in Pulse Rate | Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24 | Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as the average of the triplicate predose assessments. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 1: Change From Baseline in Respiratory Rate | Baseline (Day 1, Pre-dose) and at Day 10 | Respiratory rate was assessed at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 2: Change From Baseline in Respiratory Rate | Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24 | Respiratory rate was assessed at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 1: Change From Baseline in Temperature | Baseline (Day 1, Pre-dose) and at Day 10 | Temperature was assessed at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 2: Change From Baseline in Temperature | Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24 | Temperature was assessed at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Period 1: Absolute Values of Clinical Chemistry Parameters: Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Plasma urate, creatinine, total bilirubin and direct bilirubin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and BUN. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and BUN. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma albumin, globulin and protein. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma albumin, globulin and protein. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma amylase and lipase. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma amylase and lipase. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including creatine kinase, lactate dehydrogenase, ALT, ALP, AST and GGT. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Plasma creatine kinase, lactate dehydrogenase, ALT, ALP, AST and GGT. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Plasma urate, creatinine, total bilirubin and direct bilirubin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of hematology parameters including Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of hematology parameters including Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 1: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 2: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 1: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular volume. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 2: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular volume. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 1: Absolute Values of Hematology Parameter: Erythrocytes | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 2: Absolute Values of Hematology Parameter: Erythrocytes | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 1: Absolute Values of Hematology Parameter: Hematocrit | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of hematology parameter hematocrit. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 2: Absolute Values of Hematology Parameter: Hematocrit | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of hematology parameter hematocrit. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 1: Absolute Values of Hematology Parameter: Hemoglobin | Baseline (Day 1, Pre-dose) and at Day 10 | Blood samples were collected at indicated time points for the analysis of hematology parameter hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 2: Absolute Values of Hematology Parameter: Hemoglobin | Baseline (Day 10) and at Days 21 and 24 | Blood samples were collected at indicated time points for the analysis of hematology parameter hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 1: Absolute Values of Urine Concentration: Urine Specific Gravity | Baseline (Day 1, Pre-dose) and at Day 10 | Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 2: Absolute Values of Urine Concentration: Urine Specific Gravity | Baseline (Day 10) and at Days 21 and 24 | Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 1: Absolute Values of Urine Concentration: Urine Urobilinogen | Baseline (Day 1, Pre-dose) and at Day 10 | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 2: Absolute Values of Urine Concentration: Urine Urobilinogen | Baseline (Day 10) and at Days 21 and 24 | Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 1: Absolute Values of Urine Concentration: Urine pH | Baseline (Day 1, Pre-dose) and at Day 10 | Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 2: Absolute Values of Urine Concentration: Urine pH | Baseline (Day 10) and at Days 21 and 24 | Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Baseline (Day 1, Pre-dose) and at Day 10 | The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters (ketones, glucose, bilirubin, occult blood, nitrite and blood protein) can be read as positive, trace, 1+, 2+, 3+ and 4+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented. |
| Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Baseline (Day 10) and at Days 21 and 24 | The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters (ketones, glucose, bilirubin, occult blood, nitrite and blood protein) can be read as positive, trace, 1+, 2+, 3+ and 4+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented. |
| Period 1: Absolute Values of ECG Mean Heart Rate | Baseline (Day 1, Pre-dose) and at Day 10 | Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 2: Absolute Values of ECG Mean Heart Rate | Baseline (Day 11, Pre-dose) and at Day 11: 2, 4, 6 hours, Day 15: 2, 4, 6 hours, Day 21 and 24 | Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline is defined as the average of the triplicate predose assessments on Day 11. |
| Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | Baseline (Day 1, Pre-dose) and at Day 10 | Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | Baseline (Day 11, Pre-dose) and at Day 11- 2, 4, 6 hours, Day 15- 2, 4, 6 hours, Day 21 and 24 | Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval. Baseline is defined as the average of the triplicate predose assessments on Day 11. |
| Period 1: Absolute Values of Vital Signs: SBP and DBP | Baseline (Day 1, Pre-dose) and at Day 10 | SBP and DBP were assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as the average of the triplicate predose assessments on Day 11. |
| Period 2: Absolute Values of Vital Signs: SBP and DBP | Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24 | SBP and DBP were assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 1: Effect of GSK3640254 on PD of EE/LNG- Serum Progesterone Level | At Day 1 and Day 10 | Serum samples were collected for the analysis of progesterone concentration levels when GSK3640254 is co-administered with EE/LNG. PD concentration Population comprised of all participants who underwent plasma PD sampling and had evaluable PD assay results. |
| Period 2: Absolute Values of Pulse Rate | Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24 | Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 1: Absolute Values of Respiratory Rate | Baseline (Day 1, Pre-dose) and at Day 10 | Respiratory rate was assessed indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 2: Absolute Values of Respiratory Rate | Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24 | Respiratory rate was assessed indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 1: Absolute Values of Temperature | Baseline (Day 1, Pre-dose) and at Day 10 | Temperature was assessed at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 2: Absolute Values of Temperature | Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24 | Temperature was assessed at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 1: Absolute Values of Pulse Rate | Baseline (Day 1, Pre-dose) and at Day 10 | Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. |
| Period 2: Effect of GSK3640254 on PD of EE/LNG- Serum Progesterone Level | At Days 11, 21 and 22 | Serum samples were collected for the analysis progesterone concentration levels when GSK3640254 is co-administered with EE/LNG. |
| Period 1: Absolute Values of Effect of GSK3640254 on Luteinizing Hormone (LH) and Follicle-stimulating Hormone (FSH) | At Day 1 and Day 10 | Serum samples were collected for the analysis of effect of GSK3640254 on LH and FSH. |
| Period 2: Absolute Values of Effect of GSK3640254 on LH and FSH | At Days 11, 21 and 22 | Serum samples were collected for the analysis of effect of GSK3640254 on LH and FSH. |
| Period 2: AUC (0-tau) of GSK3640254 | Day 21: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8 and 12 and 24 hours post dose | Blood samples were collected at indicated time points for the analysis of AUC (0-tau) of GSK3640254. PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: Cmax and Ctau of GSK3640254 | Day 21: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8 and 12 and 24 hours post dose | Blood samples were collected at indicated time points for the analysis of Cmax and Ctau of GSK3640254. PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: Apparent Terminal Phase Half-life (t1/2) of GSK3640254 | Day 21: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8 and 12 hours; Day 22: 24 hours; Day 23: 48 hours; Day 24: 72 hours and Day 25: 96 hours | Blood samples were collected at indicated time points for the analysis of t1/2 of GSK3640254. PK parameters were calculated by standard non-compartmental analysis. |
| Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254 | Day 21: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8 and 12 and 24 hours post dose | Blood samples were collected at indicated time points for the analysis of Tmax of GSK3640254. PK parameters were calculated by standard non-compartmental analysis. |
Countries
United States
Participant flow
Recruitment details
This was a Phase 1, open-label, fixed-sequence, 1-way drug-drug interaction (DDI) study to assess the Pharmacokinetic (PK), pharmacodynamic (PD), safety, and tolerability of GSK3640254 and an oral contraceptive containing Ethinyl estradiol/Levonorgestrel (EE/LNG, Portia) when administered alone and in combination in healthy female participants.
Pre-assignment details
A total of 23 participants were enrolled in the study
Participants by arm
| Arm | Count |
|---|---|
| Portia Followed by Portia + GSK3640254 Participants in Run-in period received Portia (0.03 milligram \[mg\] EE/0.15 mg LNG) once daily (QD) on Day -3 through Day -1. Participants in Treatment Period 1 received Portia (0.3 mg EE/ 0.15 mg LNG) QD on Day 1 through Day 10. In Treatment Period 2 participants received Portia QD co-administered with GSK3640254 200 mg QD on Day 11 through Day 21. There was no washout period between two periods. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Treatment Period 1 (Day 1 to 10) | Sponsor decision | 2 |
| Treatment Period 2 (Day 11 to 21) | Adverse Event | 3 |
| Treatment Period 2 (Day 11 to 21) | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Portia Followed by Portia + GSK3640254 |
|---|---|
| Age, Continuous | 34.7 Years STANDARD_DEVIATION 7.82 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian-Central/South Asian Heritage | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 12 Participants |
| Race/Ethnicity, Customized White | 9 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 | 0 / 21 |
| other Total, other adverse events | 0 / 23 | 5 / 23 | 9 / 21 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 | 0 / 21 |
Outcome results
Primary
Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing Interval at Steady State (AUC [0-tau]) of EE
Blood samples were collected at indicated time points for the analysis of AUC (0-tau) of EE. PK parameters were calculated by standard non-compartmental analysis. The PK population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated.
Time frame: Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing Interval at Steady State (AUC [0-tau]) of EE | 748.7 Hour*picograms per milliliter | Geometric Coefficient of Variation 25.2 |
Primary
Period 1:AUC (0-tau) of LNG
Blood samples were collected at indicated time points for the analysis of AUC (0-tau) of LNG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1:AUC (0-tau) of LNG | 68682.4 Hour*picograms per milliliter | Geometric Coefficient of Variation 40.3 |
Primary
Period 1:Cmax and Ctau of LNG
Blood samples were collected at indicated time points for the analysis of Cmax and Ctau of LNG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours
Population: PK Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1:Cmax and Ctau of LNG | Cmax | 5806 Picograms per milliliter | Geometric Coefficient of Variation 39.3 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1:Cmax and Ctau of LNG | Ctau | 1870 Picograms per milliliter | Geometric Coefficient of Variation 49 |
Primary
Period 1: Maximum Observed Concentration (Cmax) and Plasma Concentration at the End of the Dosing Interval (Ctau) of EE
Blood samples were collected at indicated time points for the analysis of Cmax and Ctau of EE. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours
Population: PK Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Maximum Observed Concentration (Cmax) and Plasma Concentration at the End of the Dosing Interval (Ctau) of EE | Cmax | 70.01 Picograms per milliliter | Geometric Coefficient of Variation 34.9 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Maximum Observed Concentration (Cmax) and Plasma Concentration at the End of the Dosing Interval (Ctau) of EE | Ctau | 14.83 Picograms per milliliter | Geometric Coefficient of Variation 32.1 |
Primary
Period 2: AUC (0-tau) of EE
Blood samples were collected at indicated time points for the analysis of AUC (0-tau) of EE. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 and 24 hours post dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: AUC (0-tau) of EE | 735.8 Hour*picograms per milliliter | Geometric Coefficient of Variation 23.6 |
Primary
Period 2: AUC (0-tau) of LNG
Blood samples were collected at indicated time points for the analysis of AUC (0-tau) of LNG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 and 24 hours post dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: AUC (0-tau) of LNG | 75412.0 Hour*picograms per milliliter | Geometric Coefficient of Variation 40.7 |
Primary
Period 2: Cmax and Ctau of EE
Blood samples were collected at indicated time points for the analysis of Cmax and Ctau of EE. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 and 24 hours
Population: PK Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Cmax and Ctau of EE | Cmax | 68.47 Picograms per milliliter | Geometric Coefficient of Variation 33.3 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Cmax and Ctau of EE | Ctau | 15.69 Picograms per milliliter | Geometric Coefficient of Variation 27.8 |
Primary
Period 2: Cmax and Ctau of LNG
Blood samples were collected at indicated time points for the analysis of Cmax and Ctau of LNG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 and 24 hours post dose
Population: PK Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Cmax and Ctau of LNG | Cmax | 5948 Picograms per milliliter | Geometric Coefficient of Variation 36.7 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Cmax and Ctau of LNG | Ctau | 2163 Picograms per milliliter | Geometric Coefficient of Variation 46.6 |
Secondary
Number of Participants With Non-SAEs and SAE (Run-in Period)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.
Time frame: From Day -3 to Day -1
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Number of Participants With Non-SAEs and SAE (Run-in Period) | Non-serious AE | 0 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Number of Participants With Non-SAEs and SAE (Run-in Period) | SAE | 0 Participants |
Secondary
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE) (Treatment Period)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. Safety Population comprised of all participants who received at least one dose of study medication.
Time frame: Up to Day 25
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE) (Treatment Period) | Non-serious AE | 5 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE) (Treatment Period) | SAE | 0 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE) (Treatment Period) | Non-serious AE | 9 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG)+GSK3640254 | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE) (Treatment Period) | SAE | 0 Participants |
Secondary
Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT
Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including creatine kinase, lactate dehydrogenase, ALT, ALP, AST and GGT. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | ALT, Day 10 | 23.9 International units per liter | Standard Deviation 24.34 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | Creatine kinase, Baseline | 74.1 International units per liter | Standard Deviation 25.37 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | Creatine kinase, Day 10 | 70.5 International units per liter | Standard Deviation 22.43 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | Lactate dehydrogenase, Baseline | 122.7 International units per liter | Standard Deviation 21.78 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | Lactate dehydrogenase, Day 10 | 122.7 International units per liter | Standard Deviation 21.19 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | ALT, Baseline | 12.4 International units per liter | Standard Deviation 6.45 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | ALP, Baseline | 49.6 International units per liter | Standard Deviation 12 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | ALP, Day 10 | 45.7 International units per liter | Standard Deviation 11.64 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | AST, Baseline | 14.2 International units per liter | Standard Deviation 2.79 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | AST, Day 10 | 17.7 International units per liter | Standard Deviation 9.26 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | GGT, Baseline | 14.9 International units per liter | Standard Deviation 5.62 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | GGT, Day 10 | 16.7 International units per liter | Standard Deviation 11.48 |
Secondary
Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN
Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and BUN. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Triglycerides, Baseline | 1.084 Millimoles per liter | Standard Deviation 0.5437 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Triglycerides, Day 10 | 1.035 Millimoles per liter | Standard Deviation 0.394 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Glucose, Baseline | 5.104 Millimoles per liter | Standard Deviation 0.5019 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Glucose, Day 10 | 4.887 Millimoles per liter | Standard Deviation 0.4616 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Cholesterol, Baseline | 4.291 Millimoles per liter | Standard Deviation 0.9991 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Cholesterol, Day 10 | 4.138 Millimoles per liter | Standard Deviation 0.8322 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Anion gap, Baseline | 9.9 Millimoles per liter | Standard Deviation 1.1 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Anion gap, Day 10 | 11.2 Millimoles per liter | Standard Deviation 1.44 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Calcium, Baseline | 2.310 Millimoles per liter | Standard Deviation 0.0652 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Calcium, Day 10 | 2.349 Millimoles per liter | Standard Deviation 0.0593 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Carbon dioxide, Baseline | 28.0 Millimoles per liter | Standard Deviation 1.17 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Carbon dioxide, Day 10 | 26.2 Millimoles per liter | Standard Deviation 1.44 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Chloride, Baseline | 103.4 Millimoles per liter | Standard Deviation 1.41 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Chloride, Day 10 | 103.6 Millimoles per liter | Standard Deviation 1.83 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Phosphate, Baseline | 1.165 Millimoles per liter | Standard Deviation 0.1 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Phosphate, Day 10 | 1.135 Millimoles per liter | Standard Deviation 0.0881 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Potassium, Baseline | 4.23 Millimoles per liter | Standard Deviation 0.288 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Potassium, Day 10 | 4.20 Millimoles per liter | Standard Deviation 0.265 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Sodium, Baseline | 137.1 Millimoles per liter | Standard Deviation 1.24 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Sodium, Day 10 | 136.7 Millimoles per liter | Standard Deviation 1.57 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | BUN, Baseline | 3.659 Millimoles per liter | Standard Deviation 0.7512 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | BUN, Day 10 | 3.478 Millimoles per liter | Standard Deviation 0.6738 |
Secondary
Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein
Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma albumin, globulin and protein. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Globulin, Day 10 | 29.8 Grams per liter | Standard Deviation 2.93 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Albumin, Baseline | 42.0 Grams per liter | Standard Deviation 2.29 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Albumin, Day 10 | 42.0 Grams per liter | Standard Deviation 2.16 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Globulin, Baseline | 28.8 Grams per liter | Standard Deviation 2.57 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Protein, Baseline | 70.9 Grams per liter | Standard Deviation 4.06 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Protein, Day 10 | 71.8 Grams per liter | Standard Deviation 4.25 |
Secondary
Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase
Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma amylase and lipase. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase | Amylase, Baseline | 49.4 Units per liter | Standard Deviation 18.77 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase | Amylase, Day 10 | 48.7 Units per liter | Standard Deviation 16.34 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase | Lipase, Baseline | 18.8 Units per liter | Standard Deviation 9.25 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase | Lipase, Day 10 | 20.9 Units per liter | Standard Deviation 8.47 |
Secondary
Period 1: Absolute Values of Clinical Chemistry Parameters: Urate, Creatinine, Total Bilirubin and Direct Bilirubin
Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Plasma urate, creatinine, total bilirubin and direct bilirubin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Urate, Baseline | 260.4 Micromoles per liter | Standard Deviation 46.1 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Urate, Day 10 | 242.4 Micromoles per liter | Standard Deviation 46.3 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Creatinine, Baseline | 67.75 Micromoles per liter | Standard Deviation 8.763 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Creatinine, Day 10 | 68.68 Micromoles per liter | Standard Deviation 9.846 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Total bilirubin, Baseline | 8.35 Micromoles per liter | Standard Deviation 3.847 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Total bilirubin, Day 10 | 7.79 Micromoles per liter | Standard Deviation 3.48 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Direct bilirubin, Baseline | 1.88 Micromoles per liter | Standard Deviation 0.871 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Clinical Chemistry Parameters: Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Direct bilirubin, Day 10 | 1.67 Micromoles per liter | Standard Deviation 0.701 |
Secondary
Period 1: Absolute Values of ECG Mean Heart Rate
Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of ECG Mean Heart Rate | Baseline | 67.9 Beats per minute | Standard Deviation 10.09 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of ECG Mean Heart Rate | Day 10 | 67.0 Beats per minute | Standard Deviation 7.07 |
Secondary
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR interval, Baseline | 156.1 Milliseconds | Standard Deviation 20.37 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | PR interval, Day 10 | 158.6 Milliseconds | Standard Deviation 19.93 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS duration, Baseline | 85.7 Milliseconds | Standard Deviation 9.86 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QRS duration, Day 10 | 85.9 Milliseconds | Standard Deviation 8.81 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT interval, Baseline | 389.8 Milliseconds | Standard Deviation 22.39 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QT interval, Day 10 | 386.8 Milliseconds | Standard Deviation 19.95 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF interval, Baseline | 404.7 Milliseconds | Standard Deviation 13.56 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcF interval, Day 10 | 400.6 Milliseconds | Standard Deviation 12.77 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB interval, Baseline | 412.0 Milliseconds | Standard Deviation 18.41 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval | QTcB interval, Day 10 | 407.4 Milliseconds | Standard Deviation 14.28 |
Secondary
Period 1: Absolute Values of Effect of GSK3640254 on Luteinizing Hormone (LH) and Follicle-stimulating Hormone (FSH)
Serum samples were collected for the analysis of effect of GSK3640254 on LH and FSH.
Time frame: At Day 1 and Day 10
Population: PD concentration Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Effect of GSK3640254 on Luteinizing Hormone (LH) and Follicle-stimulating Hormone (FSH) | LH, Day 1 | 9.500 International units per liter | Standard Deviation 11.0104 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Effect of GSK3640254 on Luteinizing Hormone (LH) and Follicle-stimulating Hormone (FSH) | LH, Day 10 | 2.747 International units per liter | Standard Deviation 1.9554 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Effect of GSK3640254 on Luteinizing Hormone (LH) and Follicle-stimulating Hormone (FSH) | FSH, Day 1 | 5.109 International units per liter | Standard Deviation 3.7754 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Effect of GSK3640254 on Luteinizing Hormone (LH) and Follicle-stimulating Hormone (FSH) | FSH, Day 10 | 2.215 International units per liter | Standard Deviation 1.4567 |
Secondary
Period 1: Absolute Values of Hematology Parameter: Erythrocytes
Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameter: Erythrocytes | Baseline | 4.316 10^12 cells per liter | Standard Deviation 0.3113 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameter: Erythrocytes | Day 10 | 4.306 10^12 cells per liter | Standard Deviation 0.3008 |
Secondary
Period 1: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline | 29.70 Picograms | Standard Deviation 2.01 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 10 | 29.62 Picograms | Standard Deviation 2.228 |
Secondary
Period 1: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular volume. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline | 87.83 Femtoliters | Standard Deviation 5.06 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 10 | 87.65 Femtoliters | Standard Deviation 4.991 |
Secondary
Period 1: Absolute Values of Hematology Parameter: Hematocrit
Blood samples were collected at indicated time points for the analysis of hematology parameter hematocrit. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameter: Hematocrit | Baseline | 0.3783 Proportion of red blood cells in blood | Standard Deviation 0.02759 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameter: Hematocrit | Day 10 | 0.3769 Proportion of red blood cells in blood | Standard Deviation 0.02467 |
Secondary
Period 1: Absolute Values of Hematology Parameter: Hemoglobin
Blood samples were collected at indicated time points for the analysis of hematology parameter hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameter: Hemoglobin | Baseline | 128.0 Grams per liter | Standard Deviation 10.06 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameter: Hemoglobin | Day 10 | 127.2 Grams per liter | Standard Deviation 9.29 |
Secondary
Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Blood samples were collected at indicated time points for the analysis of hematology parameters including Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, Baseline | 0.038 10^9 cells per liter | Standard Deviation 0.0239 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, Day 10 | 0.038 10^9 cells per liter | Standard Deviation 0.0177 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, Baseline | 0.103 10^9 cells per liter | Standard Deviation 0.0555 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, Day 10 | 0.111 10^9 cells per liter | Standard Deviation 0.0606 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, Baseline | 6.23 10^9 cells per liter | Standard Deviation 1.626 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, Day 10 | 6.21 10^9 cells per liter | Standard Deviation 1.329 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, Baseline | 1.730 10^9 cells per liter | Standard Deviation 0.3832 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, Day 10 | 1.816 10^9 cells per liter | Standard Deviation 0.3399 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, Baseline | 0.460 10^9 cells per liter | Standard Deviation 0.1238 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, Day 10 | 0.448 10^9 cells per liter | Standard Deviation 0.1144 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, Baseline | 3.905 10^9 cells per liter | Standard Deviation 1.2865 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, Day 10 | 3.802 10^9 cells per liter | Standard Deviation 1.1472 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, Baseline | 284.4 10^9 cells per liter | Standard Deviation 36.78 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, Day 10 | 282.8 10^9 cells per liter | Standard Deviation 45.94 |
Secondary
Period 1: Absolute Values of Pulse Rate
Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Pulse Rate | Baseline | 70.1 Beats per minute | Standard Deviation 10.2 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Pulse Rate | Day 10 | 70.0 Beats per minute | Standard Deviation 9.28 |
Secondary
Period 1: Absolute Values of Respiratory Rate
Respiratory rate was assessed indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Respiratory Rate | Baseline | 13.6 Breaths per minute | Standard Deviation 2.56 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Respiratory Rate | Day 10 | 15.8 Breaths per minute | Standard Deviation 2.33 |
Secondary
Period 1: Absolute Values of Temperature
Temperature was assessed at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Temperature | Baseline | 36.66 Degree Celsius | Standard Deviation 0.487 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Temperature | Day 10 | 36.77 Degree Celsius | Standard Deviation 0.335 |
Secondary
Period 1: Absolute Values of Urine Concentration: Urine pH
Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Urine Concentration: Urine pH | Baseline | 6.09 pH | Standard Deviation 0.468 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Urine Concentration: Urine pH | Day 10 | 5.87 pH | Standard Deviation 0.31 |
Secondary
Period 1: Absolute Values of Urine Concentration: Urine Specific Gravity
Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Urine Concentration: Urine Specific Gravity | Baseline | 1.0136 Ratio | Standard Deviation 0.00693 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Urine Concentration: Urine Specific Gravity | Day 10 | 1.0159 Ratio | Standard Deviation 0.00766 |
Secondary
Period 1: Absolute Values of Urine Concentration: Urine Urobilinogen
Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Urine Concentration: Urine Urobilinogen | Baseline | 3.3860 Micromoles per liter | Standard Deviation 0 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Urine Concentration: Urine Urobilinogen | Day 10 | 5.1526 Micromoles per liter | Standard Deviation 4.66388 |
Secondary
Period 1: Absolute Values of Vital Signs: SBP and DBP
SBP and DBP were assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as the average of the triplicate predose assessments on Day 11.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Vital Signs: SBP and DBP | SBP, Day 10 | 111.4 Millimeters of mercury | Standard Deviation 12.58 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Vital Signs: SBP and DBP | SBP, Baseline | 115.7 Millimeters of mercury | Standard Deviation 8.5 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Vital Signs: SBP and DBP | DBP, Baseline | 71.9 Millimeters of mercury | Standard Deviation 8.87 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Absolute Values of Vital Signs: SBP and DBP | DBP, Day 10 | 69.1 Millimeters of mercury | Standard Deviation 8.71 |
Secondary
Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN)
Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and BUN. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Glucose | -0.217 Millimoles per liter | Standard Deviation 0.3567 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Cholesterol | -0.153 Millimoles per liter | Standard Deviation 0.3219 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Triglycerides | -0.049 Millimoles per liter | Standard Deviation 0.2231 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Anion gap | 1.3 Millimoles per liter | Standard Deviation 1.66 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Calcium | 0.039 Millimoles per liter | Standard Deviation 0.0626 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Carbon dioxide | -1.8 Millimoles per liter | Standard Deviation 1.3 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Chloride | 0.1 Millimoles per liter | Standard Deviation 1.82 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Phosphate | -0.030 Millimoles per liter | Standard Deviation 0.1056 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Potassium | -0.03 Millimoles per liter | Standard Deviation 0.343 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) | Sodium | -0.3 Millimoles per liter | Standard Deviation 2.12 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and Blood Urea Nitrogen (BUN) | BUN | -0.180 Millimoles per liter | Standard Deviation 0.5956 |
Secondary
Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein
Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma albumin, globulin and protein. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Albumin | -0.1 Grams per liter | Standard Deviation 1.62 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Globulin | 1.0 Grams per liter | Standard Deviation 1.6 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Protein | 0.9 Grams per liter | Standard Deviation 2.94 |
Secondary
Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Amylase and Lipase
Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma amylase and lipase. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Amylase and Lipase | Amylase | -0.7 Units per liter | Standard Deviation 7.83 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Amylase and Lipase | Lipase | 2.1 Units per liter | Standard Deviation 4.03 |
Secondary
Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT)
Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Plasma creatine kinase, lactate dehydrogenase, ALT, ALP, AST and GGT. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Creatine kinase | -3.6 International units per liter | Standard Deviation 19.7 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | lactate dehydrogenase | 0.0 International units per liter | Standard Deviation 11.76 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT | 11.5 International units per liter | Standard Deviation 24.8 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALP | -3.9 International units per liter | Standard Deviation 5.89 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST | 3.6 International units per liter | Standard Deviation 9.74 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT | 1.7 International units per liter | Standard Deviation 8.36 |
Secondary
Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin
Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Plasma urate, creatinine, total bilirubin and direct bilirubin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Urate | -18.0 Micromoles per liter | Standard Deviation 19.09 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Creatinine | 0.93 Micromoles per liter | Standard Deviation 3.079 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Total bilirubin | -0.57 Micromoles per liter | Standard Deviation 1.638 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Direct bilirubin | -0.21 Micromoles per liter | Standard Deviation 0.467 |
Secondary
Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval
Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval | PR interval | 2.5 Milliseconds | Standard Deviation 8.65 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval | QRS duration | 0.2 Milliseconds | Standard Deviation 5.01 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval | QT interval | -3.0 Milliseconds | Standard Deviation 11.32 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval | QTcF interval | -4.1 Milliseconds | Standard Deviation 8.18 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval | QTcB interval | -4.6 Milliseconds | Standard Deviation 11.8 |
Secondary
Period 1: Change From Baseline in Electrocardiogram (ECG) Mean Heart Rate
Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Electrocardiogram (ECG) Mean Heart Rate | -0.8 Beats per minute | Standard Deviation 5.95 |
Secondary
Period 1: Change From Baseline in Hematology Parameter: Erythrocytes
Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Hematology Parameter: Erythrocytes | -0.010 10^12 cells per liter | Standard Deviation 0.1287 |
Secondary
Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | -0.09 Picograms | Standard Deviation 0.366 |
Secondary
Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular volume. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | -0.18 Femtoliters | Standard Deviation 0.657 |
Secondary
Period 1: Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected at indicated time points for the analysis of hematology parameter hematocrit. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Hematology Parameter: Hematocrit | -0.0014 Proportion of red blood cells in blood | Standard Deviation 0.01165 |
Secondary
Period 1: Change From Baseline in Hematology Parameter: Hemoglobin
Blood samples were collected at indicated time points for the analysis of hematology parameter hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Hematology Parameter: Hemoglobin | -0.7 Grams per liter | Standard Deviation 3.74 |
Secondary
Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Blood samples were collected at indicated time points for the analysis of hematology parameters including Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils | -0.103 10^9 cells per liter | Standard Deviation 0.7505 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils | 0.000 10^9 cells per liter | Standard Deviation 0.0133 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils | 0.008 10^9 cells per liter | Standard Deviation 0.0263 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes | -0.02 10^9 cells per liter | Standard Deviation 0.867 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes | 0.086 10^9 cells per liter | Standard Deviation 0.2168 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes | -0.012 10^9 cells per liter | Standard Deviation 0.076 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets | -1.6 10^9 cells per liter | Standard Deviation 32.32 |
Secondary
Period 1: Change From Baseline in Pulse Rate
Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as the average of the triplicate predose assessments. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Pulse Rate | -0.2 Beats per minute | Standard Deviation 5.16 |
Secondary
Period 1: Change From Baseline in Respiratory Rate
Respiratory rate was assessed at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Respiratory Rate | 2.3 Breaths per minute | Standard Deviation 2.58 |
Secondary
Period 1: Change From Baseline in Temperature
Temperature was assessed at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Temperature | 0.11 Degree Celsius | Standard Deviation 0.452 |
Secondary
Period 1: Change From Baseline in Urine Concentration: Urine Potential of Hydrogen (pH)
Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Urine Concentration: Urine Potential of Hydrogen (pH) | -0.22 pH | Standard Deviation 0.473 |
Secondary
Period 1: Change From Baseline in Urine Concentration: Urine Specific Gravity
Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Urine Concentration: Urine Specific Gravity | 0.0023 Ratio | Standard Deviation 0.00922 |
Secondary
Period 1: Change From Baseline in Urine Concentration: Urine Urobilinogen
Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Urine Concentration: Urine Urobilinogen | 1.7666 Micromoles per liter | Standard Deviation 4.66388 |
Secondary
Period 1: Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as the average of the triplicate pre-dose assessments. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | -4.3 Millimeters of mercury | Standard Deviation 9.45 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | -2.8 Millimeters of mercury | Standard Deviation 7.84 |
Secondary
Period 1: Effect of GSK3640254 on PD of EE/LNG- Serum Progesterone Level
Serum samples were collected for the analysis of progesterone concentration levels when GSK3640254 is co-administered with EE/LNG. PD concentration Population comprised of all participants who underwent plasma PD sampling and had evaluable PD assay results.
Time frame: At Day 1 and Day 10
Population: PD concentration Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Effect of GSK3640254 on PD of EE/LNG- Serum Progesterone Level | Day 1 | 6.103 Nanomoles per liter | Standard Deviation 5.0947 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Effect of GSK3640254 on PD of EE/LNG- Serum Progesterone Level | Day 10 | 4.410 Nanomoles per liter | Standard Deviation 1.537 |
Secondary
Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method.
The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters (ketones, glucose, bilirubin, occult blood, nitrite and blood protein) can be read as positive, trace, 1+, 2+, 3+ and 4+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented.
Time frame: Baseline (Day 1, Pre-dose) and at Day 10
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine Ketone, Day 10, Trace | 1 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine Ketone, Day 10, 1+ | 1 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine leukocyte esterase, Day 10, 1+ | 2 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine Nitrite, Baseline, Positive | 1 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine occult blood, Baseline, 1+ | 1 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine occult blood, Baseline, 2+ | 2 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine occult blood, Baseline, 3+ | 2 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine occult blood, Day 10, Trace | 1 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine occult blood, Day 10, 1+ | 2 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine occult blood, Day 10, 3+ | 1 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine protein, Day 10, Trace | 1 Participants |
Secondary
Period 1: t1/2 of EE
Blood samples were collected at indicated time points for the analysis of t1/2 of EE. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: t1/2 of EE | NA Hours |
Secondary
Period 1: t1/2 of LNG
Blood samples were collected at indicated time points for the analysis of t1/2 of LNG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: t1/2 of LNG | NA Hours |
Secondary
Period 1: Tmax of EE
Blood samples were collected at indicated time points for the analysis of Tmax of EE. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Tmax of EE | 2.000 Hours |
Secondary
Period 1: Tmax of LNG
Blood samples were collected at indicated time points for the analysis of Tmax of LNG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 11: 24 hours
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 1: Tmax of LNG | 2.000 Hours |
Secondary
Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN
Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and BUN. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Anion gap, Day 24, n=17 | 10.5 Millimoles per liter | Standard Deviation 1.42 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Calcium, Baseline, n=21 | 2.349 Millimoles per liter | Standard Deviation 0.0602 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Sodium, Day 21, n=17 | 135.4 Millimoles per liter | Standard Deviation 1.46 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Glucose, Baseline, n=21 | 4.921 Millimoles per liter | Standard Deviation 0.4503 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Glucose, Day 21, n=17 | 4.769 Millimoles per liter | Standard Deviation 0.3922 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Glucose, Day 24, n=17 | 4.994 Millimoles per liter | Standard Deviation 0.3746 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Cholesterol, Baseline, n=21 | 4.104 Millimoles per liter | Standard Deviation 0.8622 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Cholesterol, Day 21, n=17 | 3.857 Millimoles per liter | Standard Deviation 0.8765 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Cholesterol, Day 24, n=17 | 4.093 Millimoles per liter | Standard Deviation 1.0474 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Triglycerides, Baseline, n=21 | 1.032 Millimoles per liter | Standard Deviation 0.4092 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Triglycerides, Day 21, n=17 | 1.080 Millimoles per liter | Standard Deviation 0.4505 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Triglycerides, Day 24, n=17 | 1.022 Millimoles per liter | Standard Deviation 0.5161 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Anion gap, Baseline, n=21 | 11.2 Millimoles per liter | Standard Deviation 1.48 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Anion gap, Day 21, n=17 | 9.6 Millimoles per liter | Standard Deviation 1.46 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Calcium, Day 21, n=17 | 2.314 Millimoles per liter | Standard Deviation 0.0706 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Calcium, Day 24, n=17 | 2.348 Millimoles per liter | Standard Deviation 0.0592 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Carbon dioxide, Baseline, n=21 | 26.0 Millimoles per liter | Standard Deviation 1.43 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Carbon dioxide, Day 21, n=17 | 26.7 Millimoles per liter | Standard Deviation 1.57 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Carbon dioxide, Day 24, n=17 | 27.6 Millimoles per liter | Standard Deviation 1.33 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Chloride, Baseline, n=21 | 103.7 Millimoles per liter | Standard Deviation 1.74 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Chloride, Day 21, n=17 | 103.0 Millimoles per liter | Standard Deviation 2.18 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Chloride, Day 24, n=17 | 104.1 Millimoles per liter | Standard Deviation 2.01 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Phosphate, Baseline, n=21 | 1.139 Millimoles per liter | Standard Deviation 0.0819 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Phosphate, Day 21, n=17 | 1.055 Millimoles per liter | Standard Deviation 0.0908 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Phosphate, Day 24, n=17 | 1.065 Millimoles per liter | Standard Deviation 0.0818 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Potassium, Baseline, n=21 | 4.18 Millimoles per liter | Standard Deviation 0.211 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Potassium, Day 21, n=17 | 4.12 Millimoles per liter | Standard Deviation 0.198 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Potassium, Day 24, n=17 | 4.16 Millimoles per liter | Standard Deviation 0.197 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Sodium, Baseline, n=21 | 136.9 Millimoles per liter | Standard Deviation 1.39 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Sodium, Day 24, n=17 | 138.1 Millimoles per liter | Standard Deviation 1.56 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | BUN, Baseline, n=21 | 3.458 Millimoles per liter | Standard Deviation 0.6189 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | BUN, Day 21, n=17 | 2.756 Millimoles per liter | Standard Deviation 0.4593 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | BUN, Day 24, n=17 | 2.853 Millimoles per liter | Standard Deviation 0.5406 |
Secondary
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein
Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma albumin, globulin and protein. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Protein, Baseline, n=21 | 71.6 Grams per liter | Standard Deviation 4.4 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Albumin, Baseline, n=21 | 41.9 Grams per liter | Standard Deviation 2.21 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Albumin, Day 21, n=17 | 41.4 Grams per liter | Standard Deviation 1.62 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Albumin, Day 24, n=17 | 42.0 Grams per liter | Standard Deviation 2.12 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Globulin, Baseline, n=21 | 29.7 Grams per liter | Standard Deviation 2.99 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Globulin, Day 21, n=17 | 29.2 Grams per liter | Standard Deviation 2.7 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Globulin, Day 24, n=17 | 30.4 Grams per liter | Standard Deviation 2.5 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Protein, Day 21, n=17 | 70.5 Grams per liter | Standard Deviation 3.68 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Protein, Day 24, n=17 | 72.4 Grams per liter | Standard Deviation 3.97 |
Secondary
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase
Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma amylase and lipase. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase | Amylase, Baseline, n=21 | 47.8 Units per liter | Standard Deviation 16.79 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase | Amylase, Day 21, n=17 | 47.1 Units per liter | Standard Deviation 17.93 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase | Amylase, Day 24, n=17 | 49.2 Units per liter | Standard Deviation 18.38 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase | Lipase, Baseline, n=21 | 20.7 Units per liter | Standard Deviation 8.83 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase | Lipase, Day 21, n=17 | 20.5 Units per liter | Standard Deviation 7.4 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Amylase and Lipase | Lipase, Day 24, n=17 | 20.4 Units per liter | Standard Deviation 8.16 |
Secondary
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT
Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Plasma creatine kinase, lactate dehydrogenase, ALT, ALP, AST and GGT. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | ALT, Day 24, n=17 | 51.1 International units per liter | Standard Deviation 45.07 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | ALP, Baseline, n=21 | 44.9 International units per liter | Standard Deviation 10.91 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | GGT, Baseline, n=21 | 16.4 International units per liter | Standard Deviation 11.6 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | Creatine kinase, Baseline, n=21 | 70.3 International units per liter | Standard Deviation 23.37 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | Creatine kinase, Day 21, n=17 | 69.4 International units per liter | Standard Deviation 23.62 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | Creatine kinase, Day 24, n=17 | 69.3 International units per liter | Standard Deviation 22.46 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | Lactate dehydrogenase, Baseline, n=21 | 123.3 International units per liter | Standard Deviation 21.96 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | Lactate dehydrogenase, Day 21, n=17 | 125.9 International units per liter | Standard Deviation 24.85 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | Lactate dehydrogenase, Day 24, n=17 | 130.1 International units per liter | Standard Deviation 27.63 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | ALT, Baseline, n=21 | 25.7 International units per liter | Standard Deviation 27.34 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | ALT, Day 21, n=17 | 42.2 International units per liter | Standard Deviation 32.02 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | ALP, Day 21, n=17 | 43.5 International units per liter | Standard Deviation 10.46 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | ALP, Day 24, n=17 | 42.6 International units per liter | Standard Deviation 10.1 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | AST, Baseline, n=21 | 17.7 International units per liter | Standard Deviation 9.05 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | AST, Day 21, n=17 | 25.4 International units per liter | Standard Deviation 14.55 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | AST, Day 24, n=17 | 27.9 International units per liter | Standard Deviation 20.07 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | GGT, Day 21, n=17 | 13.0 International units per liter | Standard Deviation 4.53 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | GGT, Day 24, n=17 | 13.1 International units per liter | Standard Deviation 4.45 |
Secondary
Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin
Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Plasma urate, creatinine, total bilirubin and direct bilirubin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Total bilirubin, Day 24, n=17 | 6.99 Micromoles per liter | Standard Deviation 2.323 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Direct bilirubin, Baseline, n=21 | 1.72 Micromoles per liter | Standard Deviation 0.699 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Direct bilirubin, Day 21, n=17 | 1.56 Micromoles per liter | Standard Deviation 0.498 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Direct bilirubin, Day 24, n=17 | 1.64 Micromoles per liter | Standard Deviation 0.592 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Urate, Baseline, n=21 | 240.3 Micromoles per liter | Standard Deviation 43.74 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Urate, Day 21, n=17 | 194.5 Micromoles per liter | Standard Deviation 35.17 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Urate, Day 24, n=17 | 205.1 Micromoles per liter | Standard Deviation 39.09 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Creatinine, Baseline, n=21 | 68.62 Micromoles per liter | Standard Deviation 10.637 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Creatinine, Day 21, n=17 | 66.92 Micromoles per liter | Standard Deviation 6.77 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Creatinine, Day 24, n=17 | 67.70 Micromoles per liter | Standard Deviation 7.456 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Total bilirubin, Baseline, n=21 | 7.98 Micromoles per liter | Standard Deviation 3.563 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Total bilirubin, Day 21, n=17 | 6.94 Micromoles per liter | Standard Deviation 1.6 |
Secondary
Period 2: Absolute Values of ECG Mean Heart Rate
Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline is defined as the average of the triplicate predose assessments on Day 11.
Time frame: Baseline (Day 11, Pre-dose) and at Day 11: 2, 4, 6 hours, Day 15: 2, 4, 6 hours, Day 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Mean Heart Rate | Day 15: 4 hours, n=18 | 65.8 Beats per minute | Standard Deviation 9.53 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Mean Heart Rate | Baseline, n=21 | 64.6 Beats per minute | Standard Deviation 8.49 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Mean Heart Rate | Day 11: 2 hours, n=21 | 67.4 Beats per minute | Standard Deviation 7.89 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Mean Heart Rate | Day 11: 4 hours, n=21 | 64.0 Beats per minute | Standard Deviation 6.73 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Mean Heart Rate | Day 11: 6 hours, n=21 | 71.3 Beats per minute | Standard Deviation 7.59 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Mean Heart Rate | Day 15: 2 hours, n=18 | 67.9 Beats per minute | Standard Deviation 9.42 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Mean Heart Rate | Day 15: 6 hours, n=18 | 67.2 Beats per minute | Standard Deviation 8.8 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Mean Heart Rate | Day 21, n=18 | 67.8 Beats per minute | Standard Deviation 7.72 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Mean Heart Rate | Day 24, n=17 | 64.5 Beats per minute | Standard Deviation 7.41 |
Secondary
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval
Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval. Baseline is defined as the average of the triplicate predose assessments on Day 11.
Time frame: Baseline (Day 11, Pre-dose) and at Day 11- 2, 4, 6 hours, Day 15- 2, 4, 6 hours, Day 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QT interval, Day 15: 2 hours, n=18 | 382.9 Milliseconds | Standard Deviation 18.9 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QT interval, Day 15: 4 hours, n=18 | 392.8 Milliseconds | Standard Deviation 24.36 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | PR interval, Baseline, n=21 | 159.1 Milliseconds | Standard Deviation 18.22 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | PR interval, Day 11: 2 hours, n=21 | 159.4 Milliseconds | Standard Deviation 19.73 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | PR interval, Day 11: 4 hours, n=21 | 161.0 Milliseconds | Standard Deviation 18.73 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | PR interval, Day 11: 6 hours, n=21 | 157.2 Milliseconds | Standard Deviation 20.08 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | PR interval, Day 15: 2 hours, n=18 | 158.7 Milliseconds | Standard Deviation 21.29 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | PR interval, Day 15: 4 hours, n=18 | 159.8 Milliseconds | Standard Deviation 17.11 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | PR interval, Day 15: 6 hours, n=18 | 158.1 Milliseconds | Standard Deviation 17.46 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | PR interval, Day 21, n=18 | 162.1 Milliseconds | Standard Deviation 18.06 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | PR interval, Day 24, n=17 | 162.8 Milliseconds | Standard Deviation 15.26 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QRS duration, Baseline, n=21 | 85.5 Milliseconds | Standard Deviation 7.4 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QRS duration, Day 11: 2 hours, n=21 | 83.3 Milliseconds | Standard Deviation 6.57 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QRS duration, Day 11: 4 hours, n=21 | 84.9 Milliseconds | Standard Deviation 10.17 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QRS duration, Day 11: 6 hours, n=21 | 85.2 Milliseconds | Standard Deviation 8.05 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QRS duration, Day 15: 2 hours, n=18 | 84.8 Milliseconds | Standard Deviation 6.68 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QRS duration, Day 15: 4 hours, n=18 | 84.6 Milliseconds | Standard Deviation 8.33 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QRS duration, Day 15: 6 hours, n=18 | 83.6 Milliseconds | Standard Deviation 8.44 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QRS duration, Day 21, n=18 | 84.1 Milliseconds | Standard Deviation 9.46 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QRS duration, Day 24, n=17 | 83.5 Milliseconds | Standard Deviation 8.6 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QT interval, Baseline, n=21 | 394.2 Milliseconds | Standard Deviation 22.09 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QT interval, Day 11: 2 hours, n=21 | 377.8 Milliseconds | Standard Deviation 20.18 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QT interval, Day 11: 4 hours, n=21 | 396.5 Milliseconds | Standard Deviation 21.88 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QT interval, Day 11: 6 hours, n=21 | 382.5 Milliseconds | Standard Deviation 22.01 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QT interval, Day 15: 6 hours, n=18 | 395.3 Milliseconds | Standard Deviation 25.6 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QT interval, Day 21, n=18 | 385.7 Milliseconds | Standard Deviation 25.68 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QT interval, Day 24, n=17 | 394.2 Milliseconds | Standard Deviation 22.25 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcF interval, Baseline, n=21 | 403.2 Milliseconds | Standard Deviation 12.93 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcF interval, Day 11: 2 hours, n=21 | 391.8 Milliseconds | Standard Deviation 10.63 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcF interval, Day 11: 4 hours, n=21 | 404.6 Milliseconds | Standard Deviation 12.78 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcF interval, Day 11: 6 hours, n=21 | 404.5 Milliseconds | Standard Deviation 14.13 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcF interval, Day 15: 2 hours, n=18 | 398.2 Milliseconds | Standard Deviation 11.51 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcF interval, Day 15: 4 hours, n=18 | 403.6 Milliseconds | Standard Deviation 11.73 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcF interval, Day 15: 6 hours, n=18 | 409.3 Milliseconds | Standard Deviation 12.19 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcF interval, Day 21, n=18 | 400.8 Milliseconds | Standard Deviation 13.69 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcF interval, Day 24, n=17 | 403.0 Milliseconds | Standard Deviation 12.02 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcB interval, Baseline, n=21 | 407.2 Milliseconds | Standard Deviation 16.45 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcB interval, Day 11: 2 hours, n=21 | 398.7 Milliseconds | Standard Deviation 12.38 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcB interval, Day 11: 4 hours, n=21 | 408.2 Milliseconds | Standard Deviation 12.46 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcB interval, Day 11: 6 hours, n=21 | 415.4 Milliseconds | Standard Deviation 15.09 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcB interval, Day 15: 2 hours, n=18 | 405.5 Milliseconds | Standard Deviation 16.82 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcB interval, Day 15: 4 hours, n=18 | 408.8 Milliseconds | Standard Deviation 13.73 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcB interval, Day 15: 6 hours, n=18 | 415.9 Milliseconds | Standard Deviation 11.36 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcB interval, Day 21, n=18 | 407.9 Milliseconds | Standard Deviation 11.29 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcB interval, Day 24, n=17 | 407.2 Milliseconds | Standard Deviation 12.99 |
Secondary
Period 2: Absolute Values of Effect of GSK3640254 on LH and FSH
Serum samples were collected for the analysis of effect of GSK3640254 on LH and FSH.
Time frame: At Days 11, 21 and 22
Population: PD concentration Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Effect of GSK3640254 on LH and FSH | LH, Day 11, n=21 | 2.255 International units per liter | Standard Deviation 1.6299 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Effect of GSK3640254 on LH and FSH | LH, Day 21, n=17 | 1.202 International units per liter | Standard Deviation 0.6667 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Effect of GSK3640254 on LH and FSH | LH, Day 22, n=17 | 1.287 International units per liter | Standard Deviation 0.8298 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Effect of GSK3640254 on LH and FSH | FSH, Day 11, n=21 | 2.162 International units per liter | Standard Deviation 1.4388 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Effect of GSK3640254 on LH and FSH | FSH, Day 21, n=17 | 1.535 International units per liter | Standard Deviation 0.8285 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Effect of GSK3640254 on LH and FSH | FSH, Day 22, n=17 | 1.638 International units per liter | Standard Deviation 1.238 |
Secondary
Period 2: Absolute Values of Hematology Parameter: Erythrocytes
Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameter: Erythrocytes | Baseline, n=21 | 4.308 10^12 cells per liter | Standard Deviation 0.3103 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameter: Erythrocytes | Day 21, n=17 | 4.356 10^12 cells per liter | Standard Deviation 0.2518 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameter: Erythrocytes | Day 24, n=17 | 4.383 10^12 cells per liter | Standard Deviation 0.2998 |
Secondary
Period 2: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Baseline, n=21 | 29.92 Picograms | Standard Deviation 2.068 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 21, n=17 | 29.72 Picograms | Standard Deviation 1.779 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 24, n=17 | 30.12 Picograms | Standard Deviation 1.867 |
Secondary
Period 2: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular volume. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Baseline, n=21 | 88.16 Femtoliters | Standard Deviation 4.889 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 21, n=17 | 88.39 Femtoliters | Standard Deviation 4.293 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 24, n=17 | 88.92 Femtoliters | Standard Deviation 4.278 |
Secondary
Period 2: Absolute Values of Hematology Parameter: Hematocrit
Blood samples were collected at indicated time points for the analysis of hematology parameter hematocrit. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameter: Hematocrit | Baseline, n=21 | 0.3791 Proportion of red blood cells in blood | Standard Deviation 0.02457 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameter: Hematocrit | Day 21, n=17 | 0.3848 Proportion of red blood cells in blood | Standard Deviation 0.0265 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameter: Hematocrit | Day 24, n=17 | 0.3895 Proportion of red blood cells in blood | Standard Deviation 0.02969 |
Secondary
Period 2: Absolute Values of Hematology Parameter: Hemoglobin
Blood samples were collected at indicated time points for the analysis of hematology parameter hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameter: Hemoglobin | Baseline, n=21 | 128.5 Grams per liter | Standard Deviation 8.61 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameter: Hemoglobin | Day 21, n=17 | 129.5 Grams per liter | Standard Deviation 10.22 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameter: Hemoglobin | Day 24, n=17 | 132.1 Grams per liter | Standard Deviation 11.23 |
Secondary
Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Blood samples were collected at indicated time points for the analysis of hematology parameters including Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, Baseline, n=21 | 0.039 10^9 cells per liter | Standard Deviation 0.0184 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, Day 21, n=17 | 0.039 10^9 cells per liter | Standard Deviation 0.0183 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, Day 24, n=17 | 0.038 10^9 cells per liter | Standard Deviation 0.0142 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, Baseline, n=21 | 0.115 10^9 cells per liter | Standard Deviation 0.0622 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, Day 21, n=17 | 0.118 10^9 cells per liter | Standard Deviation 0.0631 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, Day 24, n=17 | 0.112 10^9 cells per liter | Standard Deviation 0.0645 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, Baseline, n=21 | 6.20 10^9 cells per liter | Standard Deviation 1.391 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, Day 21, n=17 | 5.86 10^9 cells per liter | Standard Deviation 1.183 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, Day 24, n=17 | 5.41 10^9 cells per liter | Standard Deviation 1.08 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, Baseline, n=21 | 1.790 10^9 cells per liter | Standard Deviation 0.3089 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, Day 21, n=17 | 1.715 10^9 cells per liter | Standard Deviation 0.3349 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, Day 24, n=17 | 1.710 10^9 cells per liter | Standard Deviation 0.2207 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, Baseline, n=21 | 0.446 10^9 cells per liter | Standard Deviation 0.1186 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, Day 21, n=17 | 0.409 10^9 cells per liter | Standard Deviation 0.0942 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, Day 24, n=17 | 0.391 10^9 cells per liter | Standard Deviation 0.0924 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, Baseline, n=21 | 3.811 10^9 cells per liter | Standard Deviation 1.2013 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, Day 21, n=17 | 3.587 10^9 cells per liter | Standard Deviation 1.0893 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, Day 24, n=17 | 3.165 10^9 cells per liter | Standard Deviation 0.9633 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, Baseline, n=21 | 282.2 10^9 cells per liter | Standard Deviation 46.73 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, Day 21, n=17 | 296.8 10^9 cells per liter | Standard Deviation 50.45 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, Day 24, n=17 | 291.4 10^9 cells per liter | Standard Deviation 42.75 |
Secondary
Period 2: Absolute Values of Pulse Rate
Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Pulse Rate | Baseline, n=21 | 69.2 Beats per minute | Standard Deviation 12.19 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Pulse Rate | Day 15, n=19 | 73.5 Beats per minute | Standard Deviation 8.62 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Pulse Rate | Day 21, n=18 | 69.4 Beats per minute | Standard Deviation 7.11 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Pulse Rate | Day 24, n=17 | 68.4 Beats per minute | Standard Deviation 7.63 |
Secondary
Period 2: Absolute Values of Respiratory Rate
Respiratory rate was assessed indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Respiratory Rate | Baseline, n=21 | 13.2 Breaths per minute | Standard Deviation 2.41 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Respiratory Rate | Day 15, n=19 | 15.1 Breaths per minute | Standard Deviation 2.93 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Respiratory Rate | Day 21, n=18 | 14.1 Breaths per minute | Standard Deviation 1.88 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Respiratory Rate | Day 24, n=17 | 14.5 Breaths per minute | Standard Deviation 2.6 |
Secondary
Period 2: Absolute Values of Temperature
Temperature was assessed at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Temperature | Baseline, n=21 | 36.60 Degree Celsius | Standard Deviation 0.434 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Temperature | Day 15, n=19 | 36.75 Degree Celsius | Standard Deviation 0.391 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Temperature | Day 21, n=18 | 36.59 Degree Celsius | Standard Deviation 0.424 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Temperature | Day 24, n=17 | 36.82 Degree Celsius | Standard Deviation 0.481 |
Secondary
Period 2: Absolute Values of Urine Concentration: Urine pH
Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Urine Concentration: Urine pH | Baseline, n=21 | 5.88 pH | Standard Deviation 0.312 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Urine Concentration: Urine pH | Day 21, n=18 | 6.28 pH | Standard Deviation 0.428 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Urine Concentration: Urine pH | Day 24, n=17 | 6.12 pH | Standard Deviation 0.219 |
Secondary
Period 2: Absolute Values of Urine Concentration: Urine Specific Gravity
Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Urine Concentration: Urine Specific Gravity | Baseline, n=21 | 1.0162 Ratio | Standard Deviation 0.00792 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Urine Concentration: Urine Specific Gravity | Day 21, n=18 | 1.0134 Ratio | Standard Deviation 0.00982 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Urine Concentration: Urine Specific Gravity | Day 24, n=17 | 1.0139 Ratio | Standard Deviation 0.00807 |
Secondary
Period 2: Absolute Values of Urine Concentration: Urine Urobilinogen
Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Urine Concentration: Urine Urobilinogen | Baseline, n=21 | 5.3209 Micromoles per liter | Standard Deviation 4.85645 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Urine Concentration: Urine Urobilinogen | Day 21, n=18 | 7.9007 Micromoles per liter | Standard Deviation 6.56981 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Urine Concentration: Urine Urobilinogen | Day 24, n=17 | 4.1827 Micromoles per liter | Standard Deviation 3.2849 |
Secondary
Period 2: Absolute Values of Vital Signs: SBP and DBP
SBP and DBP were assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment.
Time frame: Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Vital Signs: SBP and DBP | SBP, Baseline, n=21 | 110.0 Millimeters of mercury | Standard Deviation 8.24 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Vital Signs: SBP and DBP | SBP, Day 15, n=19 | 113.3 Millimeters of mercury | Standard Deviation 6.63 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Vital Signs: SBP and DBP | SBP, Day 21, n=18 | 110.1 Millimeters of mercury | Standard Deviation 5.22 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Vital Signs: SBP and DBP | SBP, Day 24, n=17 | 114.5 Millimeters of mercury | Standard Deviation 7 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Vital Signs: SBP and DBP | DBP, Baseline, n=21 | 64.6 Millimeters of mercury | Standard Deviation 7.69 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Vital Signs: SBP and DBP | DBP, Day 15, n=19 | 66.7 Millimeters of mercury | Standard Deviation 5.85 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Vital Signs: SBP and DBP | DBP, Day 21, n=18 | 67.4 Millimeters of mercury | Standard Deviation 6.01 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Absolute Values of Vital Signs: SBP and DBP | DBP, Day 24, n=17 | 69.7 Millimeters of mercury | Standard Deviation 6.63 |
Secondary
Period 2: Apparent Terminal Phase Half-life (t1/2) of GSK3640254
Blood samples were collected at indicated time points for the analysis of t1/2 of GSK3640254. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 21: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8 and 12 hours; Day 22: 24 hours; Day 23: 48 hours; Day 24: 72 hours and Day 25: 96 hours
Population: PK Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Apparent Terminal Phase Half-life (t1/2) of GSK3640254 | 25.656 Hours | Geometric Coefficient of Variation 19.1 |
Secondary
Period 2: AUC (0-tau) of GSK3640254
Blood samples were collected at indicated time points for the analysis of AUC (0-tau) of GSK3640254. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 21: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8 and 12 and 24 hours post dose
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: AUC (0-tau) of GSK3640254 | 30.22 Hour*micrograms per milliliter | Geometric Coefficient of Variation 23.1 |
Secondary
Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN
Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and BUN. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Glucose, Day 24 | 0.084 Millimoles per liter | Standard Deviation 0.2043 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Cholesterol, Day 21 | -0.161 Millimoles per liter | Standard Deviation 0.2891 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Chloride, Day 21 | -0.6 Millimoles per liter | Standard Deviation 1.06 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Chloride, Day 24 | 0.5 Millimoles per liter | Standard Deviation 1.33 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Glucose, Day 21 | -0.141 Millimoles per liter | Standard Deviation 0.2553 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Cholesterol, Day 24 | 0.075 Millimoles per liter | Standard Deviation 0.458 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Triglycerides, Day 21 | -0.008 Millimoles per liter | Standard Deviation 0.1524 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Triglycerides, Day 24 | -0.066 Millimoles per liter | Standard Deviation 0.1786 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Anion gap, Day 21 | -1.5 Millimoles per liter | Standard Deviation 1.12 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Anion gap, Day 24 | -0.6 Millimoles per liter | Standard Deviation 1.8 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Calcium, Day 21 | -0.034 Millimoles per liter | Standard Deviation 0.0546 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Calcium, Day 24 | 0.000 Millimoles per liter | Standard Deviation 0.0643 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Carbon dioxide, Day 21 | 0.7 Millimoles per liter | Standard Deviation 1.16 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Carbon dioxide, Day 24 | 1.6 Millimoles per liter | Standard Deviation 0.87 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Phosphate, Day 21 | -0.074 Millimoles per liter | Standard Deviation 0.1073 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Phosphate, Day 24 | -0.064 Millimoles per liter | Standard Deviation 0.0878 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Potassium, Day 21 | -0.06 Millimoles per liter | Standard Deviation 0.253 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Potassium, Day 24 | -0.02 Millimoles per liter | Standard Deviation 0.235 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Sodium, Day 21 | -1.2 Millimoles per liter | Standard Deviation 1.03 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | Sodium, Day 24 | 1.5 Millimoles per liter | Standard Deviation 1.66 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | BUN, Day 21 | -0.664 Millimoles per liter | Standard Deviation 0.5033 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium and BUN | BUN, Day 24 | -0.568 Millimoles per liter | Standard Deviation 0.4591 |
Secondary
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein
Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma albumin, globulin and protein. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Albumin, Day 21 | -0.5 Grams per liter | Standard Deviation 1.46 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Albumin, Day 24 | 0.1 Grams per liter | Standard Deviation 2.52 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Globulin, Day 21 | -0.4 Grams per liter | Standard Deviation 1.54 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Globulin, Day 24 | 0.8 Grams per liter | Standard Deviation 1.91 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Protein, Day 21 | -0.9 Grams per liter | Standard Deviation 2.73 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Albumin, Globulin and Protein | Protein, Day 24 | 0.9 Grams per liter | Standard Deviation 4.31 |
Secondary
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Amylase and Lipase
Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including plasma amylase and lipase. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Amylase and Lipase | Amylase, Day 21 | 3.2 Units per liter | Standard Deviation 6.03 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Amylase and Lipase | Amylase, Day 24 | 5.2 Units per liter | Standard Deviation 6.69 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Amylase and Lipase | Lipase, Day 21 | 1.8 Units per liter | Standard Deviation 3.77 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Amylase and Lipase | Lipase, Day 24 | 1.6 Units per liter | Standard Deviation 3.33 |
Secondary
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT
Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Plasma creatine kinase, lactate dehydrogenase, ALT, ALP, AST and GGT. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | Lactate dehydrogenase, Day 21 | 4.2 Units per liter | Standard Deviation 10.61 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | Creatine kinase, Day 21 | -1.6 Units per liter | Standard Deviation 9.51 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | Creatine kinase, Day 24 | -1.7 Units per liter | Standard Deviation 12.18 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | Lactate dehydrogenase, Day 24 | 8.4 Units per liter | Standard Deviation 16 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | ALT, Day 21 | 25.7 Units per liter | Standard Deviation 24.8 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | ALT, Day 24 | 34.5 Units per liter | Standard Deviation 37.36 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | ALP, Day 21 | -1.1 Units per liter | Standard Deviation 2.38 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | ALP, Day 24 | -1.9 Units per liter | Standard Deviation 3.6 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | AST, Day 21 | 10.1 Units per liter | Standard Deviation 9.97 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | AST, Day 24 | 12.6 Units per liter | Standard Deviation 15.62 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | GGT, Day 21 | 0.0 Units per liter | Standard Deviation 1.73 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST and GGT | GGT, Day 24 | 0.1 Units per liter | Standard Deviation 1.6 |
Secondary
Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin
Blood samples were collected at indicated time points for the analysis of clinical chemistry parameters including Plasma urate, creatinine, total bilirubin and direct bilirubin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Creatinine, Day 21 | 0.52 Micromoles per liter | Standard Deviation 2.852 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Urate, Day 21 | -45.2 Micromoles per liter | Standard Deviation 19.22 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Urate, Day 24 | -34.7 Micromoles per liter | Standard Deviation 19.63 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Creatinine, Day 24 | 1.29 Micromoles per liter | Standard Deviation 3.013 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Total bilirubin, Day 21 | 0.08 Micromoles per liter | Standard Deviation 1 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Total bilirubin, Day 24 | 0.12 Micromoles per liter | Standard Deviation 1.177 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Direct bilirubin, Day 21 | 0.07 Micromoles per liter | Standard Deviation 0.214 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Clinical Chemistry Parameters: Plasma Urate, Creatinine, Total Bilirubin and Direct Bilirubin | Direct bilirubin, Day 24 | 0.15 Micromoles per liter | Standard Deviation 0.318 |
Secondary
Period 2: Change From Baseline in ECG Mean Heart Rate
Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline is defined as the average of the triplicate predose assessments on Day 11. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 11, Pre-dose) and at Day 11: 2, 4, 6 hours, Day 15: 2, 4, 6 hours, Day 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Mean Heart Rate | Day 15: 6 hours, n=18 | 3.1 Beats per minute | Standard Deviation 7.1 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Mean Heart Rate | Day 11: 2 hours, n=21 | 2.8 Beats per minute | Standard Deviation 5.17 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Mean Heart Rate | Day 11: 4 hours, n=21 | -0.6 Beats per minute | Standard Deviation 4.79 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Mean Heart Rate | Day 11: 6 hours, n=21 | 6.7 Beats per minute | Standard Deviation 5.44 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Mean Heart Rate | Day 15: 2 hours, n=18 | 3.8 Beats per minute | Standard Deviation 6.23 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Mean Heart Rate | Day 15: 4 hours, n=18 | 1.7 Beats per minute | Standard Deviation 8.01 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Mean Heart Rate | Day 21, n=18 | 3.7 Beats per minute | Standard Deviation 6.24 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Mean Heart Rate | Day 24, n=17 | 0.6 Beats per minute | Standard Deviation 4.42 |
Secondary
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval
Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline is defined as the average of the triplicate predose assessments on Day 11. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 11, Pre-dose) and at Day 11: 2, 4, 6 hours, Day 15: 2, 4, 6 hours, Day 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcF interval, Day 15: 2 hours, n=18 | -3.0 Milliseconds | Standard Deviation 6.15 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcF interval, Day 15: 4 hours, n=18 | 2.4 Milliseconds | Standard Deviation 9.71 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | PR interval, Day 11: 2 hours, n=21 | 0.3 Milliseconds | Standard Deviation 7.99 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | PR interval, Day 11: 4 hours, n=21 | 1.9 Milliseconds | Standard Deviation 8.68 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | PR interval, Day 11: 6 hours, n=21 | -1.9 Milliseconds | Standard Deviation 9.45 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | PR interval, Day 15: 2 hours, n=18 | -1.7 Milliseconds | Standard Deviation 11.37 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | PR interval, Day 15: 4 hours, n=18 | -0.6 Milliseconds | Standard Deviation 10.03 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | PR interval, Day 15: 6 hours, n=18 | -2.3 Milliseconds | Standard Deviation 7.99 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | PR interval, Day 21, n=18 | 1.7 Milliseconds | Standard Deviation 7.37 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | PR interval, Day 24, n=17 | 2.1 Milliseconds | Standard Deviation 7.89 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QRS duration, Day 11: 2 hours, n=21 | -2.2 Milliseconds | Standard Deviation 3.78 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QRS duration, Day 11: 4 hours, n=21 | -0.7 Milliseconds | Standard Deviation 4.51 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QRS duration, Day 11: 6 hours, n=21 | -0.3 Milliseconds | Standard Deviation 4.33 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QRS duration, Day 15: 2 hours, n=18 | 0.2 Milliseconds | Standard Deviation 3.78 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QRS duration, Day 15: 4 hours, n=18 | 0.1 Milliseconds | Standard Deviation 3.39 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QRS duration, Day 15: 6 hours, n=18 | -0.9 Milliseconds | Standard Deviation 3.02 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QRS duration, Day 21, n=18 | -0.4 Milliseconds | Standard Deviation 4.37 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QRS duration, Day 24, n=17 | -0.4 Milliseconds | Standard Deviation 3.36 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QT interval, Day 11: 2 hours, n=21 | -16.4 Milliseconds | Standard Deviation 8.23 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QT interval, Day 11: 4 hours, n=21 | 2.3 Milliseconds | Standard Deviation 10.78 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QT interval, Day 11: 6 hours, n=21 | -11.7 Milliseconds | Standard Deviation 10.22 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QT interval, Day 15: 2 hours, n=18 | -10.3 Milliseconds | Standard Deviation 10.09 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QT interval, Day 15: 4 hours, n=18 | -0.4 Milliseconds | Standard Deviation 15.78 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QT interval, Day 15: 6 hours, n=18 | 2.2 Milliseconds | Standard Deviation 14.21 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QT interval, Day 21, n=18 | -7.4 Milliseconds | Standard Deviation 13.77 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QT interval, Day 24, n=17 | 0.1 Milliseconds | Standard Deviation 10.06 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcF interval, Day 11: 2 hours, n=21 | -11.5 Milliseconds | Standard Deviation 8.78 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcF interval, Day 11: 4 hours, n=21 | 1.4 Milliseconds | Standard Deviation 8.61 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcF interval, Day 11: 6 hours, n=21 | 1.3 Milliseconds | Standard Deviation 7.68 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcF interval, Day 15: 6 hours, n=18 | 8.1 Milliseconds | Standard Deviation 9.07 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcF interval, Day 21, n=18 | -0.3 Milliseconds | Standard Deviation 6.85 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcF interval, Day 24, n=17 | 1.4 Milliseconds | Standard Deviation 5.63 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcB interval, Day 11: 2 hours, n=21 | -8.5 Milliseconds | Standard Deviation 13.11 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcB interval, Day 11: 4 hours, n=21 | 1.0 Milliseconds | Standard Deviation 11.57 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcB interval, Day 11: 6 hours, n=21 | 8.2 Milliseconds | Standard Deviation 11.84 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcB interval, Day 15: 2 hours, n=18 | 1.1 Milliseconds | Standard Deviation 11.25 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcB interval, Day 15: 4 hours, n=18 | 4.4 Milliseconds | Standard Deviation 15.09 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcB interval, Day 15: 6 hours, n=18 | 11.6 Milliseconds | Standard Deviation 12.41 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcB interval, Day 21, n=18 | 3.6 Milliseconds | Standard Deviation 9.2 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF and QTcB Interval | QTcB interval, Day 24, n=17 | 2.5 Milliseconds | Standard Deviation 7.67 |
Secondary
Period 2: Change From Baseline in Hematology Parameter: Erythrocytes
Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 21 | 0.106 10^12 cells per liter | Standard Deviation 0.1093 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameter: Erythrocytes | Day 24 | 0.134 10^12 cells per liter | Standard Deviation 0.1675 |
Secondary
Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 21 | -0.51 Picograms | Standard Deviation 0.394 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Day 24 | -0.10 Picograms | Standard Deviation 0.377 |
Secondary
Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Blood samples were collected at indicated time points for the analysis of hematology parameter erythrocytes mean corpuscular volume. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 21 | -0.50 Femtoliters | Standard Deviation 0.516 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Day 24 | 0.04 Femtoliters | Standard Deviation 0.818 |
Secondary
Period 2: Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected at indicated time points for the analysis of hematology parameter hematocrit. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 21 | 0.0071 Proportion of red blood cells in blood | Standard Deviation 0.01046 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameter: Hematocrit | Day 24 | 0.0118 Proportion of red blood cells in blood | Standard Deviation 0.01711 |
Secondary
Period 2: Change From Baseline in Hematology Parameter: Hemoglobin
Blood samples were collected at indicated time points for the analysis of hematology parameter hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameter: Hemoglobin | Day 21 | 1.2 Grams per liter | Standard Deviation 3.63 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameter: Hemoglobin | Day 24 | 3.8 Grams per liter | Standard Deviation 5.45 |
Secondary
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Blood samples were collected at indicated time points for the analysis of hematology parameters including Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, Day 21 | 0.001 10^9 cells per liter | Standard Deviation 0.013 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Basophils, Day 24 | 0.000 10^9 cells per liter | Standard Deviation 0.015 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, Day 21 | 0.001 10^9 cells per liter | Standard Deviation 0.0209 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Eosinophils, Day 24 | -0.005 10^9 cells per liter | Standard Deviation 0.0414 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, Day 21 | -0.43 10^9 cells per liter | Standard Deviation 0.905 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Leukocytes, Day 24 | -0.88 10^9 cells per liter | Standard Deviation 0.901 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, Day 21 | -0.095 10^9 cells per liter | Standard Deviation 0.2468 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Lymphocytes, Day 24 | -0.101 10^9 cells per liter | Standard Deviation 0.1617 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, Day 21 | -0.045 10^9 cells per liter | Standard Deviation 0.0609 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Monocytes, Day 24 | -0.064 10^9 cells per liter | Standard Deviation 0.0676 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, Day 21 | -0.285 10^9 cells per liter | Standard Deviation 0.7448 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Neutrophils, Day 24 | -0.708 10^9 cells per liter | Standard Deviation 0.7253 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, Day 21 | 12.2 10^9 cells per liter | Standard Deviation 31.07 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | Platelets, Day 24 | 6.8 10^9 cells per liter | Standard Deviation 27.18 |
Secondary
Period 2: Change From Baseline in Pulse Rate
Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as the average of the triplicate predose assessments. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Pulse Rate | Day 15, n=19 | 5.8 Beats per minute | Standard Deviation 5.06 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Pulse Rate | Day 21, n=18 | 1.8 Beats per minute | Standard Deviation 5.71 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Pulse Rate | Day 24, n=17 | 0.9 Beats per minute | Standard Deviation 5.48 |
Secondary
Period 2: Change From Baseline in Respiratory Rate
Respiratory rate was assessed at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Respiratory Rate | Day 15, n=19 | 1.7 Breaths per minute | Standard Deviation 3.07 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Respiratory Rate | Day 21, n=18 | 0.6 Breaths per minute | Standard Deviation 2.15 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Respiratory Rate | Day 24, n=17 | 0.9 Breaths per minute | Standard Deviation 3.61 |
Secondary
Period 2: Change From Baseline in Temperature
Temperature was assessed at indicated time-points. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Temperature | Day 15, n=19 | 0.15 Degree Celsius | Standard Deviation 0.434 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Temperature | Day 21, n=18 | 0.02 Degree Celsius | Standard Deviation 0.537 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Temperature | Day 24, n=17 | 0.25 Degree Celsius | Standard Deviation 0.505 |
Secondary
Period 2: Change From Baseline in Urine Concentration: Urine pH
Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Urine Concentration: Urine pH | Day 24, n=17 | 0.24 pH | Standard Deviation 0.4 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Urine Concentration: Urine pH | Day 21, n=18 | 0.39 pH | Standard Deviation 0.583 |
Secondary
Period 2: Change From Baseline in Urine Concentration: Urine Specific Gravity
Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Urine Concentration: Urine Specific Gravity | Day 21, n=18 | -0.0028 Ratio | Standard Deviation 0.0115 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Urine Concentration: Urine Specific Gravity | Day 24, n=17 | -0.0021 Ratio | Standard Deviation 0.00888 |
Secondary
Period 2: Change From Baseline in Urine Concentration: Urine Urobilinogen
Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Urine Concentration: Urine Urobilinogen | Day 21, n=18 | 3.0098 Micromoles per liter | Standard Deviation 5.79402 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Urine Concentration: Urine Urobilinogen | Day 24, n=17 | 0.0000 Micromoles per liter | Standard Deviation 4.78853 |
Secondary
Period 2: Change From Baseline in Vital Signs: SBP and DBP
SBP and DBP were assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline is defined as as the average of the triplicate pre-dose assessments. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 11, Pre-dose) and at Days 15, 21 and 24
Population: Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 15, n=19 | 4.4 Millimeters of mercury | Standard Deviation 6.51 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 21, n=18 | 1.6 Millimeters of mercury | Standard Deviation 4.89 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Vital Signs: SBP and DBP | SBP, Day 24, n=17 | 5.9 Millimeters of mercury | Standard Deviation 6.95 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 15, n=19 | 3.0 Millimeters of mercury | Standard Deviation 5.08 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 21, n=18 | 3.5 Millimeters of mercury | Standard Deviation 3.38 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Change From Baseline in Vital Signs: SBP and DBP | DBP, Day 24, n=17 | 6.1 Millimeters of mercury | Standard Deviation 5.27 |
Secondary
Period 2: Cmax and Ctau of GSK3640254
Blood samples were collected at indicated time points for the analysis of Cmax and Ctau of GSK3640254. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 21: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8 and 12 and 24 hours post dose
Population: PK Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Cmax and Ctau of GSK3640254 | Cmax | 1.780 Micrograms per milliliter | Geometric Coefficient of Variation 30.4 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Cmax and Ctau of GSK3640254 | Ctau | 0.9663 Micrograms per milliliter | Geometric Coefficient of Variation 27.1 |
Secondary
Period 2: Effect of GSK3640254 on PD of EE/LNG- Serum Progesterone Level
Serum samples were collected for the analysis progesterone concentration levels when GSK3640254 is co-administered with EE/LNG.
Time frame: At Days 11, 21 and 22
Population: PD concentration Population. Only those participants with data available at specified time points has been presented (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Effect of GSK3640254 on PD of EE/LNG- Serum Progesterone Level | Day 11, n=21 | 3.906 Nanomoles per liter | Standard Deviation 1.2178 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Effect of GSK3640254 on PD of EE/LNG- Serum Progesterone Level | Day 21, n=17 | 3.618 Nanomoles per liter | Standard Deviation 0.9386 |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Effect of GSK3640254 on PD of EE/LNG- Serum Progesterone Level | Day 22, n=17 | 3.988 Nanomoles per liter | Standard Deviation 1.4316 |
Secondary
Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method.
The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters (ketones, glucose, bilirubin, occult blood, nitrite and blood protein) can be read as positive, trace, 1+, 2+, 3+ and 4+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented.
Time frame: Baseline (Day 10) and at Days 21 and 24
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine Ketone, Baseline, Trace | 1 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine Ketone, Baseline, 1+ | 1 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine Ketone, Day 21, Trace | 1 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine Ketone, Day 24, 2+ | 1 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine leukocyte esterase, Baseline, 1+ | 2 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine leukocyte esterase, Day 21, 1+ | 1 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine Nitrite, Day 21, Positive | 1 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine Nitrite, Day 24, Positive | 1 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine occult blood, Baseline, Trace | 1 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine occult blood, Baseline, 1+ | 2 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine occult blood, Baseline, 3+ | 1 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine occult blood, Day 21, Trace | 3 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine occult blood, Day 21, 3+ | 1 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine occult blood, Day 24, Trace | 1 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine occult blood, Day 24, 1+ | 2 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine occult blood, Day 24, 2+ | 1 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine occult blood, Day 24, 3+ | 1 Participants |
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Number of Participants With Abnormal Urinalysis Parameters Using Dipstick Method. | Urine Protein, Baseline, Trace | 1 Participants |
Secondary
Period 2: t1/2 of EE
Blood samples were collected at indicated time points for the analysis of t1/2 of EE. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 22: 24 hours; Day 23: 48 hours and Day 24: 72 hours
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: t1/2 of EE | 20.215 Hours | Geometric Coefficient of Variation 17.4 |
Secondary
Period 2: t1/2 of LNG
Blood samples were collected at indicated time points for the analysis of t1/2 of LNG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours; Day 22: 24 hours; Day 23: 48 hours and Day 24: 72 hours
Population: PK Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: t1/2 of LNG | 30.100 Hours | Geometric Coefficient of Variation 4.2 |
Secondary
Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254
Blood samples were collected at indicated time points for the analysis of Tmax of GSK3640254. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 21: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8 and 12 and 24 hours post dose
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254 | 4.500 Hours |
Secondary
Period 2: Tmax of EE
Blood samples were collected at indicated time points for the analysis of Tmax of EE. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours and Day 22: 24 hours; Day 23: 48 hours and Day 24: 72 hours
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Tmax of EE | 2.000 Hours |
Secondary
Period 2: Tmax of LNG
Blood samples were collected at indicated time points for the analysis of Tmax of LNG. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Day 21: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 7, 12 hours; Day 22: 24 hours; Day 23: 48 hours and Day 24: 72 hours
Population: PK Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Portia (0.3 mg EE/ 0.15 mg LNG) | Period 2: Tmax of LNG | 2.000 Hours |