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NCT04291001 · ClinicalTrials.gov registry record · Early Phase 1
Ovarian Function With ENG Implant and UPA Use
A Early Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 40
- Enrollment target
NCT04291001 is a Early Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 40 participants.
The verdict
NCT04291001, a Early Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
Same day initiation of the etonogestrel (ENG) implant and oral ulipristal acetate (UPA) would overcome contraceptive access barriers to people capable of pregnancy with recent unprotected intercourse to ongoing contraception. Current clinical guidelines recommend delaying implant initiation for at least 1 week following UPA, as well as waiting 7 days before relying on the implant for contraception after initiation alone. This pilot will assess the effects of the implant alone and the implant inserted with same-day as UPA usage on ovarian activity. A total of 40 people capable of pregnancy desiring the implant, who are not at risk for pregnancy during the study timeline, will be recruited. Participants will be randomized to implant alone or same-day implant + oral UPA. Participants will have daily ultrasounds and blood draws to assess timing of ovulation for 1 week and then an exit visit at 14 days after randomization. The primary outcome is the incidence of ovulation in the 2 randomized treatment groups. Participants may continue the implant after the study per FDA guidelines and rely on it for contraception after the study is completed.
Interventions
- DEVICE ENG implant
- DRUG oral ulipristal acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-09-04 |
| Est. Completion | 2024-01-12 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04291001
The ClinicalTrials.gov registry entry for NCT04291001 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ENG implant is the first listed.
NCT04291001 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04291001 about?
NCT04291001 is a clinical study titled "Ovarian Function With ENG Implant and UPA Use". Same day initiation of the etonogestrel (ENG) implant and oral ulipristal acetate (UPA) would overcome contraceptive access barriers to people capable of pregnancy with recent unprotected intercourse to ongoing contraception. Current clinical guidelines recommend delaying implant initiation for at l...
What is the current status of trial NCT04291001?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2020-09-04. Estimated completion is 2024-01-12.
What interventions are being tested in trial NCT04291001?
The interventions under investigation include: ENG implant (DEVICE), oral ulipristal acetate (DRUG).
Who is sponsoring clinical trial NCT04291001?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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