Actively Recruiting
Etonogestrel Implant as Emergency Contraception: A Pilot Pharmacodynamic Study
Led by University of Colorado, Denver · Updated on 2025-05-08
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of the etonogestrel contraceptive implant as a form of emergency contraception by studying its effect on ovulation when inserted before the luteinizing hormone (LH) surge. The study focuses on individuals with regular menstrual cycles and confirmed ovulation, investigating whether the implant can prevent ovulation if placed once the dominant ovarian follicle reaches 15mm or larger but before the LH surge begins. This pilot pharmacodynamic study is unique as it addresses a gap in published data and could impact current contraceptive timing recommendations. Participants will receive the etonogestrel implant inserted during their second menstrual cycle prior to ovulation. The study is an open-label, single-arm trial, meaning all participants undergo the same intervention without a comparison group or blinding. Researchers will monitor hormone levels and ovarian follicle size following implant placement to assess ovulation inhibition. During the 7-day study period after implant insertion, participants will have serum progesterone and luteinizing hormone levels measured and undergo transvaginal ultrasounds to monitor ovarian follicle size. The study will evaluate these hormonal and imaging markers to determine if ovulation is suppressed. Participants must abstain from certain medications affecting hormone metabolism and will be monitored for adherence and safety throughout the trial, which includes a follow-up period ending in December 2026.
CONDITIONS
Brief Title
Etonogestrel Implant as Emergency Contraception
Who Can Participate
Eligibility Criteria
You may qualify if you...
- BMI less than or equal to 28kg/m2
- Intact uterus with at least one ovary
- Regular menstrual cycles occurring every 21 to 35 days
- If postpartum or post-second trimester abortion, at least 3 menses (2 cycles) before enrollment
- If first trimester abortion or pregnancy loss, at least one spontaneous menses before enrollment
- Desire insertion of an etonogestrel contraceptive implant for contraception
- Not currently pregnant or trying to become pregnant
- Willing to avoid medications and supplements that affect CYP3A4 during the study
You will not qualify if you...
- Known hypersensitivity or contraindications to etonogestrel
- Medical conditions affecting liver function, such as hepatitis or cirrhosis
- Known or suspected alcohol dependence or illicit drug use affecting etonogestrel metabolism
- Uncontrolled thyroid disorder
- Use of long-acting injectable hormonal contraception within the past 9 months
- Current use of hormonal oral, patch, intravaginal, or intrauterine contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 7 days
Participants receive the insertion of the etonogestrel contraceptive implant prior to the LH surge in their second menstrual cycle before ovulation.
1 visit (implant insertion) and follow-up visits for up to 7 days
Trial Site Locations
Total: 1 location
1
University of Colorado Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
E
Emily Graves, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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