Tuberculosis
Conditions
Keywords
Oral contraceptive, GSK3036656, Fixed sequence, Ethinyl Estradiol, Levonorgestrel, Drug interaction
Brief summary
The purpose of this study is to provide data showing if there are any effects of GSK3036656 on a combined oral contraceptive containing Ethinyl Estradiol (EE) and Levonorgestrel (LNG), which will help inform future studies on suitable contraceptive measures to be used.
Interventions
DRUGMicrogynon
Participants received 1 dose of Microgynon (0.03 mg EE/0.15 mg LNG) on Day 1 of Treatment Period 1 and 1 dose co-administered with GSK3036656 20 mg on Day 15 of Treatment Period 3.
DRUGGSK3036656
Participants received 1 loading dose of 40 mg on Day 4 and a dose of 20 mg on Days 5 to 14 once daily in Treatment Period 2. In Treatment Period 3, participants received one 20 mg dose along with Microgynon (0.03 mg EE/0.15 mg LNG) on Day 15 after which a 20 mg dose on Days 17 and 18 once daily.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Open-label
Intervention model description
Fixed sequence
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Age: 1. Participant was 18 to 65 years of age, inclusive, at the time of signing the informed consent. Type of Participant and Disease Characteristics: 2. Participants were healthy or compensated, 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). 3. Creatinine clearance was \>= 75 mL/min. 4. Echocardiogram was normal or showed normal left ventricular function; at most trace to mild valvular regurgitation was allowed, with no valvular stenosis. Weight: 5. Body weight was \>= 45.0 kg (99 lbs), and body mass index was within the range 18.5 to 31.0 kg/m² (inclusive). Sex: 6. Female participants were of Nonchildbearing Potential (WONCBP). Women in the following categories were considered WONCBP: Permanently sterile due to one of the following procedures: 1. Documented hysterectomy. 2. Documented bilateral salpingectomy. 3. Documented bilateral oophorectomy. Postmenopausal females. A postmenopausal state was defined as no menses for 12 months without an alternative medical cause. * A high follicle-stimulating hormone (FSH) level in the postmenopausal range could have been used to confirm a postmenopausal state in women not using hormonal contraception or hormone replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation with \>1 FSH measurement was required within the screening period. * Females on HRT and whose menopausal status was in doubt discontinued HRT \>= 30 days prior to the start of Treatment Period 1 to allow confirmation of postmenopausal status before study enrolment. Informed Consent: 7. Participant was capable of giving signed informed consent, which included compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
Exclusion criteria
Medical History: 1. History of known cardiac valve abnormalities. Laboratory Assessments: 2. Presence of hepatitis B surface antigen at Screening or within 3 months prior to starting study treatment. 3. Positive hepatitis C antibody test result at Screening or within 3 months prior to starting study treatment, and positive on reflex to hepatitis C RNA. 4. Positive HIV-1 and -2 antigen/antibody immunoassay at Screening. 5. Alanine aminotransferase (ALT) \> 1.5×ULN. A single repeat of ALT was allowed within a single screening period to determine eligibility. 6. Bilirubin \> 1.5×ULN (isolated bilirubin \> 1.5×ULN was acceptable if bilirubin was fractionated and direct bilirubin was \< 35%). 7. Any acute laboratory abnormality at Screening which, in the opinion of the investigator, should have precluded participation in the study of an investigational compound. 8. Participants with haemoglobin \< 8.0 g/dL. 9. Any Grade 2 to 4 laboratory abnormality at Screening-except creatine phosphokinase, lipid abnormalities, and ALT (as above)-excluded a participant unless the investigator provided a compelling explanation and had sponsor assent. A single repeat of any laboratory abnormality was allowed within a single screening period. 10. Positive test result for drugs of abuse (including marijuana), alcohol, or cotinine at Screening or before the first study dose. Prior/Concomitant Therapy: 11. Participants were unable to refrain from using prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's wort), within 7 days prior to the first dose and throughout the study. Levothyroxine and omeprazole were allowed if participants had been on a stable dose for \>= 1 month prior to Treatment Period 1 and maintained the same dose. Microgynon was administered \>= 1 hour after levothyroxine or omeprazole. Other medications were allowed on a case-by-case basis with medical monitor and GSK ganfeborole team approval. 12. Participants received any vaccine within 30 days prior to study treatment. 13. Participants were unwilling to abstain from excessive consumption of caffeine, grapefruit, grapefruit juice, Seville oranges, blood oranges, pomelos, or their juices within 7 days prior to first dose through study end. 14. Participants who had undergone IVF or assisted reproductive techniques within 9 months prior to screening, were currently participating, or planned such procedures during the following year were excluded. Prior/Concurrent Clinical Study Experience: 15. Participants had taken part in another clinical study within 30 days, 5 half-lives + 10 days, or 2× duration of the investigational product's biological effect (whichever was longer). 16. Study participation resulted in donation of blood or blood products \> 500 mL within 56 days. Diagnostic Assessments: 17. Significant arrhythmia or ECG findings, in the opinion of the investigator or GSK Medical Monitor, would have interfered with participant safety. 18.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Drug Concentration (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) After a Single Dose of EE and LNG | At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group | AUC(0-inf) is defined as the area under the concentration-time curve from time 0 extrapolated to infinity and was calculated by using a non-compartmental analysis. |
| Maximum Observed Plasma Concentration (Cmax) After a Single Dose of EE and LNG | At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group | Cmax is defined as the maximum observed plasma concentration determined directly from the concentration-time data and was calculated by using a non-compartmental analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trough Plasma Concentration (Ctau) at Steady State of GSK3036656 With EE/LNG and GSK3036656 Alone | At Day 8, 10, 12, 15 and 16 | Ctau is defined as the concentration reached by the drug immediately before the next dose is administered. |
| Time to Maximum Observed Plasma Drug Concentration (Tmax) at Steady State of GSK3036656 With EE/LNG | At Day 15 | Tmax is defined as a measure of the time required to reach the maximum concentration of the drug, determined directly from the concentration-time data. |
| AUC Versus Time Curve (AUC[0-t]) of EE and LNG Alone and With GSK3036656 | At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group | AUC(0-t) is defined as area under the plasma drug concentration versus time curve from time zero (pre-dose) to last time of quantifiable concentration and was calculated by using a non-compartmental analysis. |
| Tmax of EE and LNG Alone and With GSK3036656 | At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group | Tmax is defined as a measure of the time required to reach the maximum concentration of the drug, determined directly from the concentration-time data. |
| Apparent Terminal Half-life (t1/2) of EE and LNG Alone and With GSK3036656 | At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group | t1/2 is defined as the time required by the plasma concentration to decline by 50% and was calculated by using a non-compartmental analysis. |
| Number of Participants With Serious Adverse Events (SAEs) | From the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) up to Day 18 | A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. |
| Number of Participants With Grade 3 or Higher Severity Adverse Events (AEs) | From Day 1 up to Day 18 | The intensity of AEs was assessed using the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria Version 2.1 where grades are defined based on numeric criteria as follows Grade 3: severe or medically significant; Grade 4: potentially life-threatening; Grade 5: death. A higher grade indicates greater severity. |
| AUC Versus Time Curve From Time Zero During a Dosage Interval of Time at Steady State [AUC(0-tau)] of GSK3036656 With EE/LNG | At Day 15 | AUC(0-tau) is defined as the area under the concentration-time curve over a dosing interval and was calculated by using a non-compartmental analysis. |
| Number of Participants Withdrawn From the Treatment Due to AEs | From Day 1 up to Day 18 | Adverse events resulting in withholding of study intervention administration were included in this outcome measure. |
| Number of Participants Withdrawn From the Study Due to AEs | From Day 1 up to Day 18 | — |
| Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | From Day 1 up to Day 18 | PCI ECG values are defined as any ECG findings which, in the opinion of the investigator or medical monitor would interfere with the safety of the individual participant. The ECG measurements analyzed are PR Interval, QRS Duration, and QTcF Interval. A value was reported as high for a period if it shifted from low or within range (W/in) at the start of the treatment period but was high during or at the end of the same treatment period. A value was reported as low for a period if it shifted from high or W/in at the start of the treatment period but was low during or at the end of the same treatment period. A value was reported as No Change if it remained unchanged (e.g. High to High), or as To W/in Range if it was within range. |
| Number of Participants With Clinical Chemistry Laboratory Values of PCI | From Day 1 up to Day 18 | The chemistry parameters analyzed are homocysteine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), direct bilirubin, bilirubin, calcium, creatine kinase, potassium, protein, sodium, urea, and glucose. A value was reported as high for a period if it shifted from low or within range (W/in) at the start of the treatment period but was high during or at the end of the same treatment period. A value was reported as low for a period if it shifted from high or W/in at the start of the treatment period but was low during or at the end of the same treatment period. A value was reported as No Change if it remained unchanged (e.g. High to High), or as To W/in Range if it was within range. |
| Number of Participants With Haematology Laboratory Values of PCI | From Day 1 up to Day 18 | The analyzed hematology parameters are reticulocytes/erythrocytes, monocytes/leukocytes, erythrocytes, basophils/leukocytes, eosinophils/leukocytes, mean corpuscular hemoglobin, hematocrit, hemoglobin, lymphocytes, neutrophils, and platelets. A value was reported as high for a period if it shifted from low or within range (W/in) at the start of the treatment period but was high during or at the end of the same treatment period. A value was reported as low for a period if it shifted from high or W/in at the start of the treatment period but was low during or at the end of the same treatment period. A value was reported as No Change if it remained unchanged (e.g. High to High), or as To W/in Range if it was within range. |
| Number of Participants With Vital Signs Parameters of PCI | From Day 1 up to Day 18 | The analyzed vital signs are systolic blood pressure, diastolic blood pressure, heart rate, body temperature, and respiration rate. A value was reported as high for a period if it shifted from low or within range (W/in) at the start of the treatment period but was high during or at the end of the same treatment period. A value was reported as low for a period if it shifted from high or W/in at the start of the treatment period but was low during or at the end of the same treatment period. A value was reported as No Change if it remained unchanged (e.g. High to High), or as To W/in Range if it was within range. |
| Number of Participants With Drug-related AEs Following Administration of Microgynon and Following the Administration of GSK3036656 | From Day 1 up to Day 18 | The drug-related AEs were assessed by the investigator to be possibly, probably or definitely related to the study interventions. |
| Cmax at Steady State of GSK3036656 With EE/LNG | At Day 15 | Cmax is defined as the maximum observed plasma concentration determined directly from the concentration-time data and was calculated by using a non-compartmental analysis. |
Countries
Spain
Participant flow
Pre-assignment details
The Combined Participants Group includes all participants from the 3 treatment periods combined. This group was used to summarize Participant Flow and Baseline Characteristics in the study.
Participants by arm
| Arm | Count |
|---|---|
| Combined Participants Group Participants received a dose of Microgynon \[0.03 mg Ethinyl Estradiol (EE)/0.15 mg Levonorgestrel (LNG)\] on Day 1 of Treatment Period 1. In Treatment Period 2, they received GSK3036656 40 mg on Day 4 followed by GSK3036656 20 mg once daily from Day 5 to Day 14. In Treatment Period 3, participants received Microgynon (EE/LNG) along with GSK3036656 20 mg on Day 15, followed by GSK3036656 20 mg once daily from Day 16 to Day 17. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Treatment Period 1 | Withdrawal by Subject | 1 |
| Treatment Period 2 | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Combined Participants Group |
|---|---|
| Age, Continuous | 53.6 YEARS STANDARD_DEVIATION 5.64 |
| Race/Ethnicity, Customized WHITE | 20 Participants |
| Sex: Female, Male Female | 20 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 / 20 | 0 / 19 | 0 / 18 |
| other Total, other adverse events | 4 / 20 | 1 / 19 | 1 / 18 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 | 0 / 18 |
Outcome results
Primary
Area Under the Plasma Drug Concentration (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) After a Single Dose of EE and LNG
AUC(0-inf) is defined as the area under the concentration-time curve from time 0 extrapolated to infinity and was calculated by using a non-compartmental analysis.
Time frame: At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group
Population: The analysis was performed on the Pharmacokinetic (PK) Set which includes all the participants from the Safety Set (SS) who had at least 1 non-missing PK assessment. This population is defined according to the treatment actually received by the participants and comprises only those with the specified PK parameter available for summary computation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: Microgynon Group | Area Under the Plasma Drug Concentration (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) After a Single Dose of EE and LNG | EE, Day 1 | 627.11 hour*picogram per milliliter (h*pg/mL) | Geometric Coefficient of Variation 53 |
| Treatment Period 1: Microgynon Group | Area Under the Plasma Drug Concentration (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) After a Single Dose of EE and LNG | LNG, Day 1 | 24651.76 hour*picogram per milliliter (h*pg/mL) | Geometric Coefficient of Variation 113.2 |
| Treatment Period 3: Microgynon + GSK3036656 Group | Area Under the Plasma Drug Concentration (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) After a Single Dose of EE and LNG | EE, Day 15 | 552.01 hour*picogram per milliliter (h*pg/mL) | Geometric Coefficient of Variation 51 |
| Treatment Period 3: Microgynon + GSK3036656 Group | Area Under the Plasma Drug Concentration (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) After a Single Dose of EE and LNG | LNG, Day 15 | 30334.48 hour*picogram per milliliter (h*pg/mL) | Geometric Coefficient of Variation 94.2 |
Comparison: A confirmatory hypothesis testing to test the effect of GSK3036656 on the AUC(0-inf) of EE.90% CI: [0.55, 1.41]Mixed Models Analysis
Comparison: A confirmatory hypothesis testing to test the effect of GSK3036656 on the AUC(0-inf) of LNG.90% CI: [0.98, 1.23]Mixed Models Analysis
Primary
Maximum Observed Plasma Concentration (Cmax) After a Single Dose of EE and LNG
Cmax is defined as the maximum observed plasma concentration determined directly from the concentration-time data and was calculated by using a non-compartmental analysis.
Time frame: At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group
Population: The analysis was performed on the PK Set which includes all the participants from the SS who had at least 1 non-missing PK assessment. This population is defined according to the treatment actually received by the participants and comprises only those with the specified PK parameter available for summary computation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: Microgynon Group | Maximum Observed Plasma Concentration (Cmax) After a Single Dose of EE and LNG | EE, Day 1 | 50.86 picogram per milliliter (pg/mL) | Geometric Coefficient of Variation 32.7 |
| Treatment Period 1: Microgynon Group | Maximum Observed Plasma Concentration (Cmax) After a Single Dose of EE and LNG | LNG, Day 1 | 2599.85 picogram per milliliter (pg/mL) | Geometric Coefficient of Variation 46.8 |
| Treatment Period 3: Microgynon + GSK3036656 Group | Maximum Observed Plasma Concentration (Cmax) After a Single Dose of EE and LNG | EE, Day 15 | 48.96 picogram per milliliter (pg/mL) | Geometric Coefficient of Variation 24.5 |
| Treatment Period 3: Microgynon + GSK3036656 Group | Maximum Observed Plasma Concentration (Cmax) After a Single Dose of EE and LNG | LNG, Day 15 | 2828.17 picogram per milliliter (pg/mL) | Geometric Coefficient of Variation 45.3 |
Comparison: A confirmatory hypothesis testing to test the effect of GSK3036656 on the Cmax of EE.90% CI: [0.85, 1.09]Mixed Models Analysis
Comparison: A confirmatory hypothesis testing to test the effect of GSK3036656 on the Cmax of LNG.90% CI: [0.97, 1.19]Mixed Models Analysis
Secondary
Apparent Terminal Half-life (t1/2) of EE and LNG Alone and With GSK3036656
t1/2 is defined as the time required by the plasma concentration to decline by 50% and was calculated by using a non-compartmental analysis.
Time frame: At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group
Population: The analysis was performed on the PK Set which includes all the participants from the SS who had at least 1 non-missing PK assessment. This population is defined according to the treatment actually received by the participants and comprises only those with the specified PK parameter available for summary computation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Period 1: Microgynon Group | Apparent Terminal Half-life (t1/2) of EE and LNG Alone and With GSK3036656 | LNG, Day 1 | 41.315 hour |
| Treatment Period 1: Microgynon Group | Apparent Terminal Half-life (t1/2) of EE and LNG Alone and With GSK3036656 | EE, Day 1 | 19.180 hour |
| Treatment Period 3: Microgynon + GSK3036656 Group | Apparent Terminal Half-life (t1/2) of EE and LNG Alone and With GSK3036656 | EE, Day 15 | 10.867 hour |
| Treatment Period 3: Microgynon + GSK3036656 Group | Apparent Terminal Half-life (t1/2) of EE and LNG Alone and With GSK3036656 | LNG, Day 15 | 34.697 hour |
Secondary
AUC Versus Time Curve (AUC[0-t]) of EE and LNG Alone and With GSK3036656
AUC(0-t) is defined as area under the plasma drug concentration versus time curve from time zero (pre-dose) to last time of quantifiable concentration and was calculated by using a non-compartmental analysis.
Time frame: At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group
Population: The analysis was performed on the PK Set which includes all the participants from the SS who had at least 1 non-missing PK assessment. This population is defined according to the treatment actually received by the participants and comprises only those with the specified PK parameter available for summary computation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: Microgynon Group | AUC Versus Time Curve (AUC[0-t]) of EE and LNG Alone and With GSK3036656 | EE, Day 1 | 447.10 h*pg/mL | Geometric Coefficient of Variation 58.7 |
| Treatment Period 1: Microgynon Group | AUC Versus Time Curve (AUC[0-t]) of EE and LNG Alone and With GSK3036656 | LNG, Day 1 | 21182.61 h*pg/mL | Geometric Coefficient of Variation 84.3 |
| Treatment Period 3: Microgynon + GSK3036656 Group | AUC Versus Time Curve (AUC[0-t]) of EE and LNG Alone and With GSK3036656 | EE, Day 15 | 363.00 h*pg/mL | Geometric Coefficient of Variation 43.4 |
| Treatment Period 3: Microgynon + GSK3036656 Group | AUC Versus Time Curve (AUC[0-t]) of EE and LNG Alone and With GSK3036656 | LNG, Day 15 | 23287.77 h*pg/mL | Geometric Coefficient of Variation 91.3 |
Secondary
AUC Versus Time Curve From Time Zero During a Dosage Interval of Time at Steady State [AUC(0-tau)] of GSK3036656 With EE/LNG
AUC(0-tau) is defined as the area under the concentration-time curve over a dosing interval and was calculated by using a non-compartmental analysis.
Time frame: At Day 15
Population: The analysis was performed on the PK Set which includes all the participants from the SS who had at least 1 non-missing PK assessment. This population is defined according to the treatment actually received by the participants and comprises only those with the specified PK parameter available for summary computation.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment Period 1: Microgynon Group | AUC Versus Time Curve From Time Zero During a Dosage Interval of Time at Steady State [AUC(0-tau)] of GSK3036656 With EE/LNG | 8372.42 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 18.8 |
Secondary
Cmax at Steady State of GSK3036656 With EE/LNG
Cmax is defined as the maximum observed plasma concentration determined directly from the concentration-time data and was calculated by using a non-compartmental analysis.
Time frame: At Day 15
Population: The analysis was performed on the PK Set which includes all the participants from the SS who had at least 1 non-missing PK assessment. This population is defined according to the treatment actually received by the participants and comprises only those with the specified PK parameter available for summary computation.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment Period 1: Microgynon Group | Cmax at Steady State of GSK3036656 With EE/LNG | 600.62 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 14.2 |
Secondary
Number of Participants With Clinical Chemistry Laboratory Values of PCI
The chemistry parameters analyzed are homocysteine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), direct bilirubin, bilirubin, calcium, creatine kinase, potassium, protein, sodium, urea, and glucose. A value was reported as high for a period if it shifted from low or within range (W/in) at the start of the treatment period but was high during or at the end of the same treatment period. A value was reported as low for a period if it shifted from high or W/in at the start of the treatment period but was low during or at the end of the same treatment period. A value was reported as No Change if it remained unchanged (e.g. High to High), or as To W/in Range if it was within range.
Time frame: From Day 1 up to Day 18
Population: The analysis was performed on the SS which included all the participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Bilirubin, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Glucose, To W/in Range or No Change | 19 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Protein, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Bilirubin, To W/in Range or No Change | 20 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Homocysteine, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Potassium, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Bilirubin, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | ALT, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Potassium, To W/in Range or No Change | 20 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Calcium, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Homocysteine, To High | 1 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Potassium, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Calcium, To W/in Range or No Change | 20 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Urea, To W/in Range or No Change | 19 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Creatine Kinase, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Calcium, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | AST, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Creatine Kinase, To W/in Range or No Change | 20 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Creatine Kinase, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Homocysteine, To W/in Range or No Change | 19 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Urea, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | AST, To W/in Range or No Change | 20 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Glucose, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Sodium, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | AST, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | ALT, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Sodium, To W/in Range or No Change | 20 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Direct Bilirubin, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Glucose, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Sodium, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Direct Bilirubin, To W/in Range or No Change | 20 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Urea, To High | 1 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Protein, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Direct Bilirubin, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | ALT, To W/in Range or No Change | 20 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Protein, To W/in Range or No Change | 20 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Urea, To W/in Range or No Change | 19 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Homocysteine, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Homocysteine, To W/in Range or No Change | 19 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Homocysteine, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | ALT, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | ALT, To W/in Range or No Change | 19 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | ALT, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | AST, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | AST, To W/in Range or No Change | 16 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | AST, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Direct Bilirubin, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Direct Bilirubin, To W/in Range or No Change | 17 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Direct Bilirubin, To High | 1 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Bilirubin, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Bilirubin, To W/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Bilirubin, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Calcium, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Calcium, To W/in Range or No Change | 19 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Calcium, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Creatine Kinase, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Creatine Kinase, To W/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Creatine Kinase, To High | 1 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Potassium, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Potassium, To W/in Range or No Change | 16 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Potassium, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Protein, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Protein, To W/in Range or No Change | 19 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Protein, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Sodium, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Sodium, To W/in Range or No Change | 19 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Sodium, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Urea, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Urea, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Glucose, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Glucose, To W/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Glucose, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Bilirubin, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Glucose, To W/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Protein, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Direct Bilirubin, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Urea, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Protein, To W/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Direct Bilirubin, To W/in Range or No Change | 17 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Homocysteine, To High | 3 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Protein, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Direct Bilirubin, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Homocysteine, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Sodium, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | AST, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Glucose, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Sodium, To W/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | AST, To W/in Range or No Change | 15 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Homocysteine, To W/in Range or No Change | 15 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Sodium, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | AST, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Glucose, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Creatine Kinase, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Calcium, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Urea, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Creatine Kinase, To W/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Calcium, To W/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | ALT, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Creatine Kinase, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Calcium, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | ALT, To W/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Potassium, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Bilirubin, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Urea, To W/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Potassium, To W/in Range or No Change | 15 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Bilirubin, To W/in Range or No Change | 17 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | ALT, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Clinical Chemistry Laboratory Values of PCI | Potassium, To High | 0 Participants |
Secondary
Number of Participants Withdrawn From the Study Due to AEs
Time frame: From Day 1 up to Day 18
Population: The analysis was performed on the SS which included all the participants who received at least one dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Period 1: Microgynon Group | Number of Participants Withdrawn From the Study Due to AEs | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants Withdrawn From the Study Due to AEs | 1 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants Withdrawn From the Study Due to AEs | 0 Participants |
Secondary
Number of Participants Withdrawn From the Treatment Due to AEs
Adverse events resulting in withholding of study intervention administration were included in this outcome measure.
Time frame: From Day 1 up to Day 18
Population: The analysis was performed on the SS which included all the participants who received at least one dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Period 1: Microgynon Group | Number of Participants Withdrawn From the Treatment Due to AEs | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants Withdrawn From the Treatment Due to AEs | 1 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants Withdrawn From the Treatment Due to AEs | 0 Participants |
Secondary
Number of Participants With Drug-related AEs Following Administration of Microgynon and Following the Administration of GSK3036656
The drug-related AEs were assessed by the investigator to be possibly, probably or definitely related to the study interventions.
Time frame: From Day 1 up to Day 18
Population: The analysis was performed on the SS which included all the participants who received at least one dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Period 1: Microgynon Group | Number of Participants With Drug-related AEs Following Administration of Microgynon and Following the Administration of GSK3036656 | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Drug-related AEs Following Administration of Microgynon and Following the Administration of GSK3036656 | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Drug-related AEs Following Administration of Microgynon and Following the Administration of GSK3036656 | 0 Participants |
Secondary
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI)
PCI ECG values are defined as any ECG findings which, in the opinion of the investigator or medical monitor would interfere with the safety of the individual participant. The ECG measurements analyzed are PR Interval, QRS Duration, and QTcF Interval. A value was reported as high for a period if it shifted from low or within range (W/in) at the start of the treatment period but was high during or at the end of the same treatment period. A value was reported as low for a period if it shifted from high or W/in at the start of the treatment period but was low during or at the end of the same treatment period. A value was reported as No Change if it remained unchanged (e.g. High to High), or as To W/in Range if it was within range.
Time frame: From Day 1 up to Day 18
Population: The analysis was performed on the SS which included all the participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Period 1: Microgynon Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | QRS Duration, To Low | 3 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | QTcF Interval, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | QRS Duration, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | QRS Duration, To W/in Range or No Change | 17 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | PR Interval, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | QTcF Interval, To W/in Range or No Change | 20 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | PR Interval, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | PR Interval, To W/in Range or No Change | 20 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | QTcF Interval, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | QRS Duration, To W/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | PR Interval, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | PR Interval, To W/in Range or No Change | 19 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | PR Interval, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | QRS Duration, To Low | 1 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | QRS Duration, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | QTcF Interval, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | QTcF Interval, To W/in Range or No Change | 19 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | QTcF Interval, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | PR Interval, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | PR Interval, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | QTcF Interval, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | PR Interval, To W/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | QTcF Interval, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | QRS Duration, To W/in Range or No Change | 15 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | QRS Duration, To Low | 3 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | QTcF Interval, To W/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI) | QRS Duration, To High | 0 Participants |
Secondary
Number of Participants With Grade 3 or Higher Severity Adverse Events (AEs)
The intensity of AEs was assessed using the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria Version 2.1 where grades are defined based on numeric criteria as follows Grade 3: severe or medically significant; Grade 4: potentially life-threatening; Grade 5: death. A higher grade indicates greater severity.
Time frame: From Day 1 up to Day 18
Population: The analysis was performed on the SS which included all the participants who received at least one dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Period 1: Microgynon Group | Number of Participants With Grade 3 or Higher Severity Adverse Events (AEs) | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Grade 3 or Higher Severity Adverse Events (AEs) | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Grade 3 or Higher Severity Adverse Events (AEs) | 0 Participants |
Secondary
Number of Participants With Haematology Laboratory Values of PCI
The analyzed hematology parameters are reticulocytes/erythrocytes, monocytes/leukocytes, erythrocytes, basophils/leukocytes, eosinophils/leukocytes, mean corpuscular hemoglobin, hematocrit, hemoglobin, lymphocytes, neutrophils, and platelets. A value was reported as high for a period if it shifted from low or within range (W/in) at the start of the treatment period but was high during or at the end of the same treatment period. A value was reported as low for a period if it shifted from high or W/in at the start of the treatment period but was low during or at the end of the same treatment period. A value was reported as No Change if it remained unchanged (e.g. High to High), or as To W/in Range if it was within range.
Time frame: From Day 1 up to Day 18
Population: The analysis was performed on the SS which included all the participants who received at least one dose of study medication. Only participants for whom haematology data were available were included in the analysis of this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Erythrocytes, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Eosinophils/Leukocytes, To W/in Range or No Change | 19 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Hemoglobin, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Reticulocytes/Erythrocytes, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Platelets, To W/in Range or No Change | 20 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Basophils/Leukocytes, To Low | 7 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Reticulocytes/Erythrocytes, To W/in Range or No Change | 19 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Neutrophils, To W/in Range or No Change | 20 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Hematocrit, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Reticulocytes/Erythrocytes, To High | 1 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Eosinophils/Leukocytes, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Hematocrit, To W/in Range or No Change | 20 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Mean Corpuscular Hemoglobin, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Basophils/Leukocytes, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Hematocrit, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Mean Corpuscular Hemoglobin, To W/in Range or No Change | 20 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Neutrophils, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Mean Corpuscular Hemoglobin, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Monocytes/Leukocytes, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Basophils/Leukocytes, To W/in Range or No Change | 13 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Lymphocytes, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Monocytes/Leukocytes, To W/in Range or No Change | 20 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Platelets, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Lymphocytes, To W/in Range or No Change | 20 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Monocytes/Leukocytes, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Eosinophils/Leukocytes, To Low | 1 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Lymphocytes, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Erythrocytes, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Platelets, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Hemoglobin, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Erythrocytes, To W/in Range or No Change | 20 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Neutrophils, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Haematology Laboratory Values of PCI | Hemoglobin, To W/in Range or No Change | 20 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Hematocrit, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Basophils/Leukocytes, To Low | 1 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Basophils/Leukocytes, To W/in Range or No Change | 17 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Basophils/Leukocytes, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Eosinophils/Leukocytes, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Eosinophils/Leukocytes, To W/in Range or No Change | 14 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Eosinophils/Leukocytes, To High | 4 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Monocytes/Leukocytes, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Monocytes/Leukocytes, To W/in Range or No Change | 17 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Monocytes/Leukocytes, To High | 1 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Erythrocytes, To Low | 5 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Erythrocytes, To W/in Range or No Change | 13 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Erythrocytes, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Reticulocytes/Erythrocytes, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Reticulocytes/Erythrocytes, To W/in Range or No Change | 16 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Reticulocytes/Erythrocytes, To High | 2 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Mean Corpuscular Hemoglobin, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Mean Corpuscular Hemoglobin, To W/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Mean Corpuscular Hemoglobin, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Hematocrit, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Hematocrit, To W/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Hemoglobin, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Hemoglobin, To W/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Hemoglobin, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Lymphocytes, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Lymphocytes, To W/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Lymphocytes, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Neutrophils, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Neutrophils, To W/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Neutrophils, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Platelets, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Platelets, To W/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Platelets, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Erythrocytes, To W/in Range or No Change | 17 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Platelets, To W/in Range or No Change | 17 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Hemoglobin, To W/in Range or No Change | 17 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Erythrocytes, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Neutrophils, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Hemoglobin, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Monocytes/Leukocytes, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Basophils/Leukocytes, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Lymphocytes, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Monocytes/Leukocytes, To W/in Range or No Change | 17 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Basophils/Leukocytes, To Low | 1 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Lymphocytes, To W/in Range or No Change | 17 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Monocytes/Leukocytes, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Platelets, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Lymphocytes, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Eosinophils/Leukocytes, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Basophils/Leukocytes, To W/in Range or No Change | 16 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Neutrophils, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Mean Corpuscular Hemoglobin, To W/in Range or No Change | 17 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Eosinophils/Leukocytes, To W/in Range or No Change | 15 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Mean Corpuscular Hemoglobin, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Mean Corpuscular Hemoglobin, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Platelets, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Hematocrit, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Reticulocytes/Erythrocytes, To High | 1 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Neutrophils, To W/in Range or No Change | 17 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Hematocrit, To W/in Range or No Change | 17 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Reticulocytes/Erythrocytes, To W/in Range or No Change | 16 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Reticulocytes/Erythrocytes, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Hematocrit, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Erythrocytes, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Eosinophils/Leukocytes, To Low | 2 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Haematology Laboratory Values of PCI | Hemoglobin, To Low | 0 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs)
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Time frame: From the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) up to Day 18
Population: The analysis was performed on the SS which included all the participants who received at least one dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Period 1: Microgynon Group | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Number of Participants With Vital Signs Parameters of PCI
The analyzed vital signs are systolic blood pressure, diastolic blood pressure, heart rate, body temperature, and respiration rate. A value was reported as high for a period if it shifted from low or within range (W/in) at the start of the treatment period but was high during or at the end of the same treatment period. A value was reported as low for a period if it shifted from high or W/in at the start of the treatment period but was low during or at the end of the same treatment period. A value was reported as No Change if it remained unchanged (e.g. High to High), or as To W/in Range if it was within range.
Time frame: From Day 1 up to Day 18
Population: The analysis was performed on the SS which included all the participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Period 1: Microgynon Group | Number of Participants With Vital Signs Parameters of PCI | Diastolic Blood Pressure, To w/in Range or No Change | 20 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Vital Signs Parameters of PCI | Systolic Blood Pressure, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Vital Signs Parameters of PCI | Pulse Rate, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Vital Signs Parameters of PCI | Respiratory Rate, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Vital Signs Parameters of PCI | Diastolic Blood Pressure, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Vital Signs Parameters of PCI | Respiratory Rate, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Vital Signs Parameters of PCI | Respiratory Rate, To w/in Range or No Change | 20 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Vital Signs Parameters of PCI | Temperature, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Vital Signs Parameters of PCI | Diastolic Blood Pressure, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Vital Signs Parameters of PCI | Temperature, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Vital Signs Parameters of PCI | Systolic Blood Pressure, To High | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Vital Signs Parameters of PCI | Pulse Rate, To Low | 0 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Vital Signs Parameters of PCI | Temperature, To w/in Range or No Change | 20 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Vital Signs Parameters of PCI | Systolic Blood Pressure, To w/in Range or No Change | 20 Participants |
| Treatment Period 1: Microgynon Group | Number of Participants With Vital Signs Parameters of PCI | Pulse Rate, To w/in Range or No Change | 20 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Systolic Blood Pressure, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Diastolic Blood Pressure, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Diastolic Blood Pressure, To w/in Range or No Change | 19 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Diastolic Blood Pressure, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Pulse Rate, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Pulse Rate, To w/in Range or No Change | 19 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Respiratory Rate, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Respiratory Rate, To w/in Range or No Change | 19 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Respiratory Rate, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Systolic Blood Pressure, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Systolic Blood Pressure, To w/in Range or No Change | 19 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Pulse Rate, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Temperature, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Temperature, To w/in Range or No Change | 19 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Temperature, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Pulse Rate, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Temperature, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Systolic Blood Pressure, To w/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Diastolic Blood Pressure, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Temperature, To w/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Systolic Blood Pressure, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Diastolic Blood Pressure, To w/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Pulse Rate, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Respiratory Rate, To w/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Respiratory Rate, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Temperature, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Respiratory Rate, To High | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Pulse Rate, To w/in Range or No Change | 18 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Diastolic Blood Pressure, To Low | 0 Participants |
| Treatment Period 3: Microgynon + GSK3036656 Group | Number of Participants With Vital Signs Parameters of PCI | Systolic Blood Pressure, To Low | 0 Participants |
Secondary
Time to Maximum Observed Plasma Drug Concentration (Tmax) at Steady State of GSK3036656 With EE/LNG
Tmax is defined as a measure of the time required to reach the maximum concentration of the drug, determined directly from the concentration-time data.
Time frame: At Day 15
Population: The analysis was performed on the PK Set which includes all the participants from the SS who had at least 1 non-missing PK assessment. This population is defined according to the treatment actually received by the participants and comprises only those with the specified PK parameter available for summary computation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Period 1: Microgynon Group | Time to Maximum Observed Plasma Drug Concentration (Tmax) at Steady State of GSK3036656 With EE/LNG | 0.95 hour |
Secondary
Tmax of EE and LNG Alone and With GSK3036656
Tmax is defined as a measure of the time required to reach the maximum concentration of the drug, determined directly from the concentration-time data.
Time frame: At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group
Population: The analysis was performed on the PK Set which includes all the participants from the SS who had at least 1 non-missing PK assessment. This population is defined according to the treatment actually received by the participants and comprises only those with the specified PK parameter available for summary computation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Period 1: Microgynon Group | Tmax of EE and LNG Alone and With GSK3036656 | EE, Day 1 | 0.967 hour |
| Treatment Period 1: Microgynon Group | Tmax of EE and LNG Alone and With GSK3036656 | LNG, Day 1 | 0.967 hour |
| Treatment Period 3: Microgynon + GSK3036656 Group | Tmax of EE and LNG Alone and With GSK3036656 | EE, Day 15 | 1.433 hour |
| Treatment Period 3: Microgynon + GSK3036656 Group | Tmax of EE and LNG Alone and With GSK3036656 | LNG, Day 15 | 0.967 hour |
Secondary
Trough Plasma Concentration (Ctau) at Steady State of GSK3036656 With EE/LNG and GSK3036656 Alone
Ctau is defined as the concentration reached by the drug immediately before the next dose is administered.
Time frame: At Day 8, 10, 12, 15 and 16
Population: The analysis was performed on the PK Set which includes all the participants from the SS who had at least 1 non-missing PK assessment. This population is defined according to the treatment actually received by the participants and comprises only those with the specified PK parameter available for summary computation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: Microgynon Group | Trough Plasma Concentration (Ctau) at Steady State of GSK3036656 With EE/LNG and GSK3036656 Alone | Day 8 | 226.92 ng/mL | Geometric Coefficient of Variation 17.9 |
| Treatment Period 1: Microgynon Group | Trough Plasma Concentration (Ctau) at Steady State of GSK3036656 With EE/LNG and GSK3036656 Alone | Day 10 | 235.54 ng/mL | Geometric Coefficient of Variation 27.5 |
| Treatment Period 1: Microgynon Group | Trough Plasma Concentration (Ctau) at Steady State of GSK3036656 With EE/LNG and GSK3036656 Alone | Day 12 | 243.40 ng/mL | Geometric Coefficient of Variation 21.9 |
| Treatment Period 3: Microgynon + GSK3036656 Group | Trough Plasma Concentration (Ctau) at Steady State of GSK3036656 With EE/LNG and GSK3036656 Alone | Day 15 | 251.26 ng/mL | Geometric Coefficient of Variation 40.3 |
| Treatment Period 3: Microgynon + GSK3036656 Group | Trough Plasma Concentration (Ctau) at Steady State of GSK3036656 With EE/LNG and GSK3036656 Alone | Day 16 | 254.91 ng/mL | Geometric Coefficient of Variation 23 |