Status:
RECRUITING
Etonogestrel Implant as Emergency Contraception
Lead Sponsor:
University of Colorado, Denver
Conditions:
Contraception
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief Summary
The investigators propose a single site, single arm, open label mechanism of action pharmacodynamic pilot study of etonogestrel implant insertion prior to an luteinizing hormone (LH) surge. The invest...
Eligibility Criteria
Inclusion
- BMI less than or equal to 28kg/m2
- Intact uterus with at least one ovary
- Regular menstrual cycles that occur every 21-35 days
- If patient is postpartum or post-second trimester abortion, 3 menses (2 cycles) must have occurred prior to enrollment
- If patient had a first trimester abortion or pregnancy loss, she must have one spontaneous menses prior to enrollment
- Desires insertion of an etonogestrel contraceptive implant for contraception
- Not currently pregnant or trying to become pregnant
- Willing to abstain from medications and supplements known to induce/inhibit CYP3A4 during the study
Exclusion
- Have a known hypersensitivity or contraindications to etonogestrel.
- Medical conditions that affect liver function (e.g., hepatitis, cirrhosis; assessed via participant self-report)
- Known or suspected current alcohol dependence syndrome or any illicit drug use that may affect the metabolism of the etonogestrel.
- Uncontrolled thyroid disorder.
- Use of long-acting injectable hormonal contraceptive within the past 9 months
- Current use of hormonal oral, patch, intravaginal, or intrauterine contraception
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05237141
Start Date
April 1 2022
End Date
December 1 2026
Last Update
May 8 2025
Active Locations (1)
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1
University of Colorado Denver
Aurora, Colorado, United States, 80045