NCT05237141 Etonogestrel Implant as Emergency Contraception
| NCT ID | NCT05237141 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Colorado, Denver |
| Condition | Contraception |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 12 participants in total. It began in 2022-04-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05237141 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Contraception. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05237141 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05237141 currently recruiting?
Yes, NCT05237141 is actively recruiting participants. Contact the research team at emily.graves@cuanschutz.edu for enrollment information.
Where is the NCT05237141 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT05237141 clinical trial?
NCT05237141 is sponsored by University of Colorado, Denver. The trial plans to enroll 12 participants.