Long Term Evaluation of Scapular-inserted Contraceptive Implants

NCT07201402 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2000040944R56HD117869
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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

Keywords

contraceptive implant; scapular insertion site; etonogestrel

Outcome Measures

Primary Outcomes (1)

• Serum etonogestrel concentrations

  Serum etonogestrel concentrations measured using a validated LC-MS assay

  Every 6 months after insertion of the etonogestrel implant for up to 36 months (3 years)

Secondary Outcomes (1)

• Progestin-related side effects

  Every 6 months after insertion of the etonogestrel contraceptive implant for up to 36 months (3 years)

Study Arms (1)

Reproductive age females

EXPERIMENTAL

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

Drug: Scapular-site insertion of etonogestrel contraceptive implant

Interventions

Scapular-site insertion of etonogestrel contraceptive implant DRUG

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

Reproductive age females

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Sex assigned at birth must be Female
• Aged 18-45 years
• 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
• Interest and willingness to use an etonogestrel contraceptive implant
• Negative pregnancy test at the time of study enrollment and not planning to become pregnant in the next 36 months
• 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
• Body-mass index ≥18.5kg/m2

You may not qualify if:

• 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
• Current breast cancer or personal history of breast cancer
• Malignant liver tumor (hepatocellular carcinoma)
• Allergic reaction to any components of the ENG implant
• Any self-reported known liver conditions that could affect drug metabolism (e.g., cirrhosis, hepatitis)
• Personal history of deep vein thrombosis (DVT), venous thromboembolism (VTE), or arterial thromboembolism (ATE).
• Currently taking and unable or unwilling to abstain from any medications or supplements known to be CYP3A inducers/inhibitors.
• Current use of a progestin-only contraceptive method containing desogestrel or etonogestrel
• History of spinal deformity (e.g., kyphosis, lordosis)
• History of shoulder or scapular surgery on the non-dominant side
• Non-dominant shoulder mobility limitations
• Previous trauma to the non-dominant scapular region
• Active skin conditions (e.g., psoriasis) in the non-dominant scapular region
• Inability to palpate the bony landmarks of the scapula due to adiposity or other body habitus

Sponsors & Collaborators

• Yale University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

RECRUITING

Related Publications (1)

• Clure C, Sheeder J, Lazorwitz A. Pilot study of a novel, alternative subdermal scapular insertion site for the etonogestrel contraceptive implant. Contraception. 2024 Jul;135:110442. doi: 10.1016/j.contraception.2024.110442. Epub 2024 Mar 27.

  PMID: 38552822 BACKGROUND

Study Officials

• Aaron Lazorwitz, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Professional Research Assistant

CONTACT

203-785-5074; birthcontrolgene@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Obstetrics, Gynecology and Reproductive Sciences

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: May 8, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study protocol and SAP will be uploaded to clinicaltrials.gov within one year of completion of all study procedures and made available indefinitely
• Access Criteria: Access to IPD uploaded to NICHD DASH will be handled via the existing DASH access protocols

Locations

US (2)