Long-term testing of an etonogestrel implant placed over the shoulder blade

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional protocol examines long-term outcomes after inserting the etonogestrel contraceptive implant at an alternative scapular (shoulder blade) site instead of the usual upper arm location. Participants assigned female at birth aged 18–45 who choose an implant will have it placed over the scapula and return for scheduled visits over at least two years to measure blood drug concentrations and record side effects and local reactions. The study includes serial pharmacokinetic sampling and standardized safety assessments, and requires participants to avoid medications or supplements that strongly affect CYP3A metabolism. The trial is led by Yale University with a collaborating site at the University of Colorado Anschutz and support from NICHD.

Why it matters

Who can join: the full rules

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
12. Allergy to lidocaine

Where it's running

• University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting
• Yale University School of Medicine
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Aaron Lazorwitz, MD — Yale University
• Study coordinator: Professional Research Assistant
• Email: birthcontrolgene@yale.edu
• Phone: 203-785-5074

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.