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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05237141
The ClinicalTrials.gov registry entry for NCT05237141 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 454-participant average among 72 other Contraception trials with a reported enrollment target (97% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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