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Recruiting NCT07201402

Long Term Evaluation of Scapular-inserted Contraceptive Implants

Phase II Interventional Contraception

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Scapular-site insertion of etonogestrel contraceptive implant.
Who it may be relevant to
Registry conditions: Contraception. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug 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 measures

  • Serum etonogestrel concentrations [Time frame: Every 6 months after insertion of the etonogestrel implant for up to 36 months (3 years)]
Secondary outcome measures (1)
  • Progestin-related side effects [Time frame: Every 6 months after insertion of the etonogestrel contraceptive implant for up to 36 months (3 years)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 2 centers
  • University of Colorado Anschutz Medical Campus — Aurora
  • Yale University School of Medicine — New Haven

Publications

  • 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

Identifiers

NCT: NCT07201402 · 2000040944 · R56HD117869

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗