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NCT03118297 · ClinicalTrials.gov registry record · Phase 3
Intervention to End Recurrent Unscheduled Bleeding Trial
A Phase 3 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 3
- Development phase
- 65
- Enrollment target
NCT03118297 is a Phase 3 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 65 participants.
The verdict
NCT03118297, a Phase 3 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 65 participants
- Enrollment target
Study Summary
The subdermal etonogestrel (ENG) implant, a long-acting reversible contraceptive (LARC) method, is among the most effective forms of reversible contraception and thus, an important tool in the quest to reduce unintended pregnancy. However, despite overall increases in LARC use in the United States from 1.5% in 2002 to 7.2% in 2011, and 11.6% most recently in 2015, implant use continues to make up a small proportion of LARC use. While evidence to explain this low uptake of implants is lacking, one potential reason is patient and provider concerns about unpredictable bleeding. As a result of this, many studies have been performed in attempts to discover therapies for unscheduled bleeding in progestin-only contraceptive users. Some of these studies include those investigating selective progesterone receptor modulators, such as mifepristone and ulipristal acetate (UPA), which did find some benefit. Although a previous study showed mixed benefit, the investigators feel that this medication has demonstrated both biologic plausibility as well as clinically important outcomes. This previous study may not be entirely translatable to the proposed research as therapies were used for different indications (prophylaxis vs. treatment) and different progestins and delivery systems were studied. Therefore, the investigators believe UPA should not be discounted as a potential therapy. UPA may provide an additional safe and effective option for treatment of irregular bleeding with implants in women. In addition, UPA is currently available in outpatient pharmacies in the U.S. as a single 30mg oral tablet. The investigators propose to investigate UPA for the treatment of unscheduled and troublesome bleeding in ENG implant users.
Interventions
- DRUG Placebo oral capsule
- DRUG Ulipristal Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2017-05-01 |
| Est. Completion | 2018-01-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03118297
The ClinicalTrials.gov registry entry for NCT03118297 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03118297 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03118297 about?
NCT03118297 is a clinical study titled "Intervention to End Recurrent Unscheduled Bleeding Trial". The subdermal etonogestrel (ENG) implant, a long-acting reversible contraceptive (LARC) method, is among the most effective forms of reversible contraception and thus, an important tool in the quest to reduce unintended pregnancy. However, despite overall increases in LARC use in the United States f...
What is the current status of trial NCT03118297?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 2017-05-01. Estimated completion is 2018-01-31.
What interventions are being tested in trial NCT03118297?
The interventions under investigation include: Placebo oral capsule (DRUG), Ulipristal Acetate (DRUG).
Who is sponsoring clinical trial NCT03118297?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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