Status:
NOT_YET_RECRUITING
Long Term Evaluation of Scapular-inserted Contraceptive Implants
Lead Sponsor:
Yale University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Contraception
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
This study aims to evaluate long-term outcomes when the etonogestrel contraceptive implant is inserted at an alternative site located over the scapular. The study will evaluate the pharmacokinetics (i...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Sex assigned at birth must be Female
- Aged 18-45 years
- In good general health as evidenced by medical history and no need for regular intensive medical interventions (e.g., inpatient admissions, surgical treatments). The Principal Investigator will be responsible for determining good general health for potential participants with complicated medical histories
- Interest and willingness to use an etonogestrel contraceptive implant
- Negative pregnancy test at the time of study enrollment and not planning to become pregnant in the next 36 months
- Willing to abstain from medications and supplements known to induce/inhibit CYP3A (e.g., rifampin, carbamazepine, ketoconazole, St. John's wort) during the study. In the inducer/inhibitor CYP3A medication is a prescribed medication, individuals must provide the prescriber information for the PI to confirm it is safe for this medication to be abstained during the study
- Body-mass index ≥18.5kg/m2
Exclusion
- Contradictions to the use of the ENG implant based on the CDC Medical Eligibility Criteria guidelines for any conditions with a category 3 or 4 recommendation
- Current breast cancer or personal history of breast cancer
- Malignant liver tumor (hepatocellular carcinoma)
- Known liver conditions that could affect drug metabolism (e.g., cirrhosis, hepatitis)
- Currently taking and unable or unwilling to abstain from any medications or supplements known to be CYP3A inducers/inhibitors
- Current use of a progestin-only contraceptive method containing desogestrel or etonogestrel
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT07201402
Start Date
November 1 2025
End Date
October 1 2027
Last Update
October 1 2025
Active Locations (2)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06520