NCT07201402 Long Term Evaluation of Scapular-inserted Contraceptive Implants
| NCT ID | NCT07201402 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Yale University |
| Condition | Contraception |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2026-05-08 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 62 participants in total. It began in 2026-05-08 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.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.
Eligibility Criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Sex assigned at birth must be Female 4. Aged 18-45 years 5. 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 6. Interest and willingness to use an etonogestrel contraceptive implant 7. Negative pregnancy test at the time of study enrollment and not planning to become pregnant in the next 36 months 8. 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 9. Body-mass index ≥18.5kg/m2 Exclusion Criteria: 1. 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 1. Current breast cancer or personal history of breast cancer 2. Malignant liver tumor (hepatocellular carcinoma) 3. Allergic reaction to any components of the ENG implant 2. Any self-reported known liver conditions that could affect drug metabolism (e.g., cirrhosis, hepatitis) 3. Personal history of deep vein thrombosis (DVT), venous thromboembolism (VTE), or arterial thromboembolism (ATE). 4. Currently taking and unable or unwilling to abstain from any medications or supplements known to be CYP3A inducers/inhibitors. 5. Current use of a progestin-only contraceptive method containing desogestrel or etonogestrel 6. History of spinal deformity (e.g., kyphosis, lordosis) 7. History of shoulder or scapular surgery on the non-dominant side 8. Non-dominant shoulder mobility limitations 9. Previous trauma to the non-dominant scapular region 10. Active skin conditions (e.g., psoriasis) in the non-dominant scapular region 11. Inability to palpate the bony landmarks of the scapula due to adiposity or other body habitus
Contact & Investigator
Aaron Lazorwitz, MD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT07201402 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Contraception. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07201402 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07201402 currently recruiting?
Yes, NCT07201402 is actively recruiting participants. Contact the research team at birthcontrolgene@yale.edu for enrollment information.
Where is the NCT07201402 trial being conducted?
This trial is being conducted at Aurora, United States, New Haven, United States.
Who is sponsoring the NCT07201402 clinical trial?
NCT07201402 is sponsored by Yale University. The principal investigator is Aaron Lazorwitz, MD at Yale University. The trial plans to enroll 62 participants.