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NCT05237141 · ClinicalTrials.gov registry record · Phase 4
Etonogestrel Implant as Emergency Contraception
A Phase 4 study of Contraception, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT05237141: Recruiting Phase 4 study of Contraception, sponsored by University of Colorado, Denver.
NCT05237141 is a Phase 4 study of Contraception that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 12 participants, below the 454-participant average among 72 other Contraception trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05237141, a Phase 4 study of Contraception, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Serial measurements of serum progesterone will be conducted after insertion of the etonogestrel implant to assess for evidence of potential ovulation (\>3ng/mL)
Conditions Studied
Interventions
- DRUG Etonogestrel implant
Study Locations (1)
Colorado
- University of Colorado Denver - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-04-01 |
| Est. Completion | 2026-12 |
| Phase | Phase 4 |
What NCT05237141 shows while recruiting
NCT05237141 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 454-participant average among 72 other Contraception trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Contraception appearing as the primary indexed condition, and to 1 intervention - of which Etonogestrel implant is the first listed.
NCT05237141 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05237141 about?
NCT05237141 is a clinical study titled "Etonogestrel Implant as Emergency Contraception". 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 ult...
What is the current status of trial NCT05237141?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2022-04-01. Estimated completion is 2026-12.
What conditions does trial NCT05237141 study?
This clinical trial studies the following conditions: Contraception.
What interventions are being tested in trial NCT05237141?
The interventions under investigation include: Etonogestrel implant (DRUG).
Who is sponsoring clinical trial NCT05237141?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05237141 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Contraception
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05237141's enrollment target sits among peer trials
12 70th of 72 higher than 2 of 72 other Contraception trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Contraception trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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