Etonogestrel Implant as Emergency Contraception

Etonogestrel Implant as Emergency Contraception: A Pilot Pharmacodynamic Study

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.

Study Overview

• Status: Recruiting
• Conditions: Contraception
• Intervention / Treatment: Drug: Etonogestrel implant

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Emily Graves, BS; Phone Number: 303-724-3514; Email: emily.graves@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Denver
      • Contact: Eva Dindinger, BA; Phone Number: 303-724-8482; Email: Eva.Dindinger@ucdenver.edu
      • Contact: MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Main cohort; Insertion of etonogestrel contraceptive implant prior to LH surge	Drug: Etonogestrel implant; Implant insertion in second menstrual cycle prior to ovulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum progesterone	Serial measurements of serum progesterone will be conducted after insertion of the etonogestrel implant to assess for evidence of potential ovulation (>3ng/mL)	7 days
Ovarian follicle size	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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Luteinizing hormone	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.	7 days

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Etonogestrel
• Other Study ID Numbers: 21-5026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Will share summary data if requested

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No