Etonogestrel Implant as Emergency Contraception
Primary Purpose
Contraception
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Etonogestrel implant
Sponsored by
About this trial
This is an interventional basic science trial for Contraception
Eligibility Criteria
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
Sites / Locations
- University of Colorado DenverRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Main cohort
Arm Description
Insertion of etonogestrel contraceptive implant prior to LH surge
Outcomes
Primary Outcome Measures
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)
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05237141
First Posted
January 18, 2022
Last Updated
April 18, 2023
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT05237141
Brief Title
Etonogestrel Implant as Emergency Contraception
Official Title
Etonogestrel Implant as Emergency Contraception: A Pilot Pharmacodynamic Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contraception
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Main cohort
Arm Type
Experimental
Arm Description
Insertion of etonogestrel contraceptive implant prior to LH surge
Intervention Type
Drug
Intervention Name(s)
Etonogestrel implant
Intervention Description
Implant insertion in second menstrual cycle prior to ovulation
Primary Outcome Measure Information:
Title
Serum progesterone
Description
Serial measurements of serum progesterone will be conducted after insertion of the etonogestrel implant to assess for evidence of potential ovulation (>3ng/mL)
Time Frame
7 days
Title
Ovarian follicle size
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Luteinizing hormone
Description
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.
Time Frame
7 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Graves, BS
Phone
303-724-3514
Email
emily.graves@cuanschutz.edu
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Dindinger, BA
Phone
303-724-8482
Email
Eva.Dindinger@ucdenver.edu
First Name & Middle Initial & Last Name & Degree
MA
First Name & Middle Initial & Last Name & Degree
Aaron Lazorwitz, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Will share summary data if requested
Learn more about this trial
Etonogestrel Implant as Emergency Contraception
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