Long Term Evaluation of Scapular-inserted Contraceptive Implants

Not Applicable

Not yet recruiting

• Conditions: Contraception
• Interventions: Drug: Scapular-site insertion of etonogestrel contraceptive implant

• Registration Number: NCT07201402
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-09-23
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Study Start: 2025-11-01
• Primary Completion: 2027-10
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 62

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. 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

   1. Current breast cancer or personal history of breast cancer
   2. Malignant liver tumor (hepatocellular carcinoma)

2. Known liver conditions that could affect drug metabolism (e.g., cirrhosis, hepatitis)

3. Currently taking and unable or unwilling to abstain from any medications or supplements known to be CYP3A inducers/inhibitors

4. Current use of a progestin-only contraceptive method containing desogestrel or etonogestrel

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reproductive age females	Scapular-site insertion of etonogestrel contraceptive implant	All study participants will be reproductive age females interested in using an etonogestrel contraceptive implant

Primary Outcome Measures

Name	Time	Method
Serum etonogestrel concentrations	Every 6 months after insertion of the etonogestrel implant for up to 36 months (3 years)	Serum etonogestrel concentrations measured using a validated LC-MS assay

Secondary Outcome Measures

Name	Time	Method
Progestin-related side effects	Every 6 months after insertion of the etonogestrel contraceptive implant for up to 36 months (3 years)	Assessment of common progestin-related side effects (e.g., nausea, headaches, bloating) using a questionnaire

Trial Locations

Locations (2)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States