Etonogestrel Implant as Emergency Contraception

Sponsor

University of Colorado, Denver (Other)

Overall Status

Recruiting

CT.gov ID

NCT05237141

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Contraception	Drug: Etonogestrel implant	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Etonogestrel Implant as Emergency Contraception: A Pilot Pharmacodynamic Study

Actual Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Serum progesterone [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)
Ovarian follicle size [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 Outcome Measures

Luteinizing hormone [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Denver	Aurora	Colorado	United States	80045

Sponsors and Collaborators

University of Colorado, Denver

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT05237141

Other Study ID Numbers:

21-5026

First Posted:

Feb 11, 2022

Last Update Posted:

Apr 19, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Emergencies

Etonogestrel

Study Results

No Results Posted as of Apr 19, 2022