Long Term Evaluation of Scapular-inserted Contraceptive Implants

Yale University

Status and phase: Not yet enrolling; Phase 2

Conditions: Contraception

Treatments: Drug: Scapular-site insertion of etonogestrel contraceptive implant

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07201402

R56HD117869 (U.S. NIH Grant/Contract)

2000040944

Details and patient eligibility

About

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.

Enrollment: 62 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Reproductive age females

Experimental group

Description:

All study participants will be reproductive age females interested in using an etonogestrel contraceptive implant

Treatment:

Drug: Scapular-site insertion of etonogestrel contraceptive implant