Long Term Evaluation of Scapular-inserted Contraceptive Implants
NCT ID: NCT07201402
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
62 participants
INTERVENTIONAL
2025-11-30
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Reproductive age females
All study participants will be reproductive age females interested in using an etonogestrel contraceptive implant
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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. Current breast cancer or personal history of breast cancer
2. Malignant liver tumor (hepatocellular carcinoma)
2. Known liver conditions that could affect drug metabolism (e.g., cirrhosis, hepatitis)
3. Currently taking and unable or unwilling to abstain from any medications or supplements known to be CYP3A inducers/inhibitors
4. Current use of a progestin-only contraceptive method containing desogestrel or etonogestrel
18 Years
45 Years
FEMALE
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Yale University
OTHER
Responsible Party
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Aaron Lazorwitz
Associate Professor of Obstetrics, Gynecology and Reproductive Sciences
Principal Investigators
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Aaron Lazorwitz, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2000040944
Identifier Type: -
Identifier Source: org_study_id
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