Actively Recruiting

Phase 2
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
NCT07201402

Long Term Evaluation of Scapular-inserted Contraceptive Implants

Led by Yale University · Updated on 2026-05-12

62

Participants Needed

2

Research Sites

73 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

E

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

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Long Term Evaluation of Scapular-inserted Contraceptive Implants

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form
  • Willingness to comply with study procedures and be available for the full duration
  • Sex assigned at birth must be female
  • Aged 18 to 45 years
  • Good general health without need for regular intensive medical treatment
  • Interest and willingness to use an etonogestrel contraceptive implant
  • Negative pregnancy test at enrollment and no plans to become pregnant in next 36 months
  • Willingness to avoid medications or supplements that affect CYP3A enzyme during the study
  • Body mass index of 18.5 kg/m2 or higher
Not Eligible

You will not qualify if you...

  • Contraindications to etonogestrel implant based on CDC guidelines including:
    • Current or past breast cancer
    • Malignant liver tumor
    • Allergic reaction to implant components
  • Known liver conditions affecting drug metabolism (e.g., cirrhosis, hepatitis)
  • History of deep vein thrombosis, venous thromboembolism, or arterial thromboembolism
  • Current use of CYP3A inducer or inhibitor medications that cannot be stopped
  • Current use of progestin-only contraceptives containing desogestrel or etonogestrel
  • History of spinal deformities like kyphosis or lordosis
  • History of surgery to non-dominant shoulder or scapula
  • Mobility limitations in non-dominant shoulder
  • Previous trauma to non-dominant scapular area
  • Active skin conditions in non-dominant scapular region
  • Inability to feel scapular bone landmarks due to body habitus

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Not Yet Recruiting

2

Yale University School of Medicine

New Haven, Connecticut, United States, 06520

Actively Recruiting

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Research Team

P

Professional Research Assistant

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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