Recruiting
Phase 2

Etonogestrel

Sponsor:

Yale University

Code:

NCT07201402

Conditions

Contraception

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Scapular-site insertion of etonogestrel contraceptive implant

Study Details

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.

Conditions

Contraception

Study ID

NCT07201402

Start date

May 8, 2026

Status verified date

Jul, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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

Study Design

Enrollment

62 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Reproductive age females

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

Interventions

Scapular-site insertion of etonogestrel contraceptive implant

Participants will undergo insertion of the etonogestrel contraceptive implant subdermally over the inferior edge of their non-dominant scapula

Primary outcome measure

  • Serum etonogestrel concentrations [ Time Frame: Every 6 months after insertion of the etonogestrel implant for up to 36 months (3 years) ]

Central Contacts and Locations

Central contacts

Professional Research Assistant

203-785-5074birthcontrolgene@yale.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Cara Clure, MD

Yale University School of Medicine

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

More Information

Sponsor

Yale University

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

  • contraceptive implant
  • scapular insertion site
  • etonogestrel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-07-27.