Actively Recruiting

Phase 4
Age: 18Years - 40Years
FEMALE
Healthy Volunteers
NCT05237141

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

Age: 18Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Colorado Denver

Aurora, Colorado, United States, 80045

Actively Recruiting

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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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Etonogestrel Implant as Emergency Contraception | DecenTrialz