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NCT Number: NCT05237141

Etonogestrel Implant as Emergency Contraception

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.

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Key information

Conditions

Contraception

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Aaron Lazorwitz, MD

PRINCIPAL_INVESTIGATOR

Eva Dindinger, BA

CONTACT

[email protected]

303-724-8482

MA

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Etonogestrel implant

Drug

Implant insertion in second menstrual cycle prior to ovulation

Primary outcomes

  1. Serum progesterone

    Time frame: 7 days

    Serial measurements of serum progesterone will be conducted after insertion of the etonogestrel implant to assess for evidence of potential ovulation (>3ng/mL)

  2. Ovarian follicle size

    Time frame: 7 days

    Serial transvaginal ultrasound measurements of the leading or dominant follicle will be conducted after insertion of the etonogestrel implant. Ovulation will be defined by follicle rupture with complete disappearance or at least a 50% reduction in the mean size of the leading follicle.

Secondary outcomes

  1. Luteinizing hormone

    Time frame: 7 days

    Serial measurements of serum luteinizing hormone will be conducted after insertion of the etonogestrel implant. These LH concentrations will be used to support the primary outcomes in assessing ovulation.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Graves, BS

CONTACT

[email protected]

303-724-3514

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Etonogestrel Implant as Emergency Contraception: A Pilot Pharmacodynamic Study

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2022
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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