Study to evaluate the bioequivalence and safety of Etonogestrel Implant in Healthy Female Participants

Not Applicable

Not yet recruiting

• Registration Number: CTRI/2024/08/072277
• Lead Sponsor: oop Therapeutics LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 - 35 day 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/m2 to 30.0 kg/m2, and weight =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:

a. Vasectomized partner (at least 6 months before enrollment)

b. Double barrier method (e.g., diaphragm with spermicide; condoms with spermicide)

c. Abstinence (must agree to use a double barrier method if they become sexually active during the study)

Exclusion Criteria

1. Postmenopausal females.

2. Weight greater than 130% of ideal body weight.

3. Pregnancy, a positive pregnancy test at Screening or Study Day -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 colposcopic 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 contraceptive (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 greater than 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 (e.g., activated protein C (APC) resistance, anti-cardiolipin antibodies, or coagulopathy).

23. Participants at increased risk for infectious endocarditis (e.g., prosthetic heart valves, rheumatic heart disease, previous endoc

Study & Design

• Study Type: BA/BE
• Study Design: Not specified