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NCT Number: NCT07201402

Long Term Evaluation of Scapular-inserted Contraceptive Implants

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.

Recruiting

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Serum etonogestrel concentrations

    Time frame: 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 outcomes

  1. Progestin-related side effects

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Professional Research Assistant

CONTACT

[email protected]

203-785-5074

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Prospective Long-term Study of Etonogestrel Contraceptive Implant Insertion at an Alternative Scapular Site

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 1, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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