Actively Recruiting
Etonogestrel Implant as Emergency Contraception
Led by University of Colorado, Denver · Updated on 2025-05-08
12
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 investigators will evaluate ovulation rates via serum levels of reproductive hormones and transvaginal ultrasound findings following placement of an etonogestrel implant once the dominant follicle reaches a size of 15mm or greater, but prior to an LH surge, in persons with prior documented regular cycles and confirmed ovulation. The researchers' hypothesis is that ovulation will be inhibited if the etonogestrel implant is placed prior to an LH surge. Based on data from the Food and Drug Administration label for Nexplanon, etonogestrel rises to levels associated with ovulation suppression within 8 hours of placement. Given this rapid increase, it is therefore plausible to assume that ovulation can be inhibited by the implant if placed prior to an LH surge. This study is novel as there have been no published studies evaluating an etonogestrel implant for this indication. The contribution of this proposed research to the literature is significant because current recommendations from the Center for Disease Control (CDC) regarding timing of etonogestrel implant placement are stringent and not patient-centered. Any day insertion of the etonogestrel implant is supported by retrospective data and this pharmacodynamic data would further support the literature for any day insertion without the need for additional emergency contraception. If results support the investigators' hypothesis, it could increase access to contraception and decrease duplicative therapy.
CONDITIONS
Official 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 that occur every 21-35 days
- If postpartum or post-second trimester abortion, at least 3 menses (2 cycles) must have occurred before enrollment
- If first trimester abortion or pregnancy loss, must have 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 current alcohol dependence or illicit drug use that may affect etonogestrel metabolism
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Colorado Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
E
Emily Graves, BS
CONTACT
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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