None listed
Conditions
Interventions
Intervention1: LSP-9759 (etonogestrel implant, 68 mg).: A single, rod-shaped implant.
This is an open-label, randomized, parallel design, in vivo/ex vivo,
bioequivalence study in healthy, premenopausa
Sponsors
Loop Therapeutics LLC
Eligibility
Inclusion criteria
Inclusion criteria: 1.Must be able, and willing, to give written Informed Consent prior to study participation in accordance with legal requirements and in a language that the participant understands. 2.Healthy, premenopausal, nonpregnant females, ages 18 to 45 years (inclusive), who are not using other hormonal contraceptive methods. 3.Have a regular menstrual cycle (21-35day cycles) without hormonal contraceptive use and at time of planned implantation (Study Day 1) be on Days 1-5 of menstrual cycle. 4.Body Mass Index (BMI) of 18.5 kg per meter square to 30.0 kg per meter square, and weight more than or equal to 45 kg. 5.Participants must be in good physical and mental health as determined by vital signs, clinical laboratory testing, physical examination, breast examination, and medical history. 6.Participants must have a negative chlamydia and gonorrhea test at Screening. 7.If heterosexually active, WOCBP must agree to use contraception considered medically adequate and appropriate throughout the course of the study and for 1 month after the removal of the implant. Acceptable contraception methods are: Bilateral tubal ligation (at least 01 year before enrollment) or Vasectomized partner (at least 6 months before enrollment) or Double barrier method (example diaphragm with spermicide; condoms with spermicide) or Abstinence (must agree to use a double barrier method if they become sexually active during the study)
Exclusion criteria
Exclusion criteria: 1.Postmenopausal females. 2.Weight more 130 percent of ideal body weight. 3.Pregnancy, a positive pregnancy test at Screening or Study Day minus 1 or lactation or plans to become pregnant during the study. 4.Vaginal delivery, cesarean delivery, or abortion within six weeks prior to implantation. 5.Known or suspected uterine or cervical neoplasia, now or in the past. 6.Known or suspected breast cancer or other progestin-sensitive cancer, now or in the past. 7.Undiagnosed vaginal discharge or undiagnosed/abnormal uterine bleeding. 8.Participants with abnormal Pap smears that require colposcopic evaluations as defined by the Fourth American Society of Colposcopy and Cervical Pathology (ASCCP) sponsored guidelines for management of cervical cancer abnormalities during the next 6 months are excluded. Participants with abnormal Pap smear and who have undergone colposcopy evaluation which has determined that a cervical procedure is not necessary during the 6 months following the colposcopy are allowed. 9.Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections. 10.Past or present history of acute liver disease or liver tumor (benign or malignant). 11.A previously inserted intrauterine device (hormonal or non-hormonal) that has not been removed within 8 weeks prior to Study Day 1. 12.Use of long-acting injectable contraceptives (depo-medroxyprogesterone) with a dose given within six months prior to Study Day 1 and at least 2 menstrual periods prior to Study Day 1. 13.Prior implanted contraception with removal less than 3 months prior to Study Day 1. 14.Prior use of oral contraceptives within 1 month to Study Day 1. 15.History or evidence of any clinically significant (as determined by the investigator) cardiovascular (including hypertension), gastrointestinal, endocrine, gynecologic, ophthalmologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary (including asthma or emphysema), neurologic, dermatologic, psychiatric (including depression), renal, and or other major disease or malignancy (excluding non-melanoma skin cancer). 16.Clinically significant findings from clinical laboratory tests at screening. 17.Participant has a positive test for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) or syphilis (VDRL) at screening or has been previously treated for hepatitis B, hepatitis C,or HIV infection. 18.Clinically significant electrocardiogram (ECG) findings or QTcF more 450 msec at Screening. 19.Participant has a known hypersensitivity reaction or contraindication to progesterone or any components of the formulation. 20.History of thrombophlebitis, venous or arterial thromboembolic diseases (thrombosis, pulmonary embolism, stroke or myocardial infarction). 21.History of surgery to the veins or arteries of the lower extremities or findings on physical exam such as presence of significant varicosities and peripheral edema. 22.Past, present, family history, known hereditary or acquired predisposition for venous and/or arterial thromboembolism (example activated protein C (APC) resistance, anti-cardiolipin antibodies, or coagulopathy). 23.Participants at increased risk for infectious endocarditis (example prosthetic heart valves, rheumatic heart disease, previous endocarditis). 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: AUC0-t and Cmax will be determined for etonogestrel To conclude bioequivalence, the 90% confidence interval of the T/R ratio must fall within bioequivalence limits of 80.00 to 125.00 percentTimepoint: A total of 21 pharmacokinetic samples (7.0 mL each) will be collected from each participant, using pre-labeled 07 mL K2EDTA vacutainers from Day 1 to Day 183. | — |
Secondary
| Measure | Time frame |
|---|---|
| Residual amount of etonogestrel from the removed implant at month 6 Safety endpoints: Adverse events, physical exam, vital sign measurements, clinical safety laboratory assessments, pregnancy testing, injection site assessments, and implant site inspections.Timepoint: PK samplesat Pre-Dose (up to 2 hours prior to implantation) & at 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168,240,336, 504 (Study Day 22), 672 (Study Day 29), 1344 (Study Day 57), 2016 (Study Day 85), 2688 (Study Day 113), 3360 (Study Day 141) & 4368 (Study Day 183) hours post dose. After 26 weeks of treatment the implant will be removed and the residual amount of etonogestrel will be assessed. | — |
Countries
India
Contacts
Public ContactDr Missamma Mulagala
Vimta Labs Limited
Outcome results
None listed