Etonogestrel Implant for Emergency Birth Control

Overseen By Emily Graves, BS

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Colorado, Denver

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals seeking emergency contraception who have regular menstrual cycles, desire an etonogestrel implant, and are not currently pregnant or trying to become pregnant. They must abstain from certain medications, have a BMI of 28kg/m2 or less, and cannot be using other hormonal contraceptives. Those with liver issues, uncontrolled thyroid disorders, or recent use of injectable hormones are excluded.

Inclusion Criteria

Willing to abstain from medications and supplements known to induce/inhibit CYP3A4 during the study

Desires insertion of an etonogestrel contraceptive implant for contraception

Regular menstrual cycles that occur every 21-35 days

Exclusion Criteria

Known or suspected current alcohol dependence syndrome or any illicit drug use that may affect the metabolism of the etonogestrel.

Current use of hormonal oral, patch, intravaginal, or intrauterine contraception

Have a known hypersensitivity or contraindications to etonogestrel.

Treatment Details

Interventions

• Etonogestrel Implant

Trial Overview The study tests if the etonogestrel implant can prevent ovulation when inserted before an LH surge in people with regular cycles. It's a pilot study where participants will receive the implant once their dominant follicle is large enough but before the LH surge occurs.

Participant Groups

Group I: Main cohort Experimental Treatment 1 Intervention

Insertion of etonogestrel contraceptive implant prior to LH surge

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+