Long Term Evaluation of Scapular-inserted Contraceptive Implants (NCT07201402) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Long Term Evaluation of Scapular-inserted Contraceptive Implants
United States62 participantsStarted 2026-03-15
Plain-language 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.e., drug levels) and side effect profiles of participants who have an etonogestrel contraceptive implant inserted at this alternative scapular site over the course of at least two years.
Who can participate
Age range18 Years β 45 Years
SexFEMALE
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Inclusion criteria
β. Provision of signed and dated informed consent form
β. Stated willingness to comply with all study procedures and availability for the duration of the study
β. Sex assigned at birth must be Female
β. Aged 18-45 years
β. 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
β. Interest and willingness to use an etonogestrel contraceptive implant
β. Negative pregnancy test at the time of study enrollment and not planning to become pregnant in the next 36 months
β. 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
Exclusion criteria
β. Self-reported contraindications 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
β. Current breast cancer or personal history of breast cancer
What they're measuring
1
Serum etonogestrel concentrations
Timeframe: Every 6 months after insertion of the etonogestrel implant for up to 36 months (3 years)