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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: Completed Phase 3 study, sponsored by Washington University School of Medicine.
NCT03118297 is a Phase 3 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 65 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate the effectiveness of ulipristal acetate (15mg) in decreasing bleeding/spotting days due to the ENG implant over a 30-day period as compared to placebo.
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 |
What the finished NCT03118297 record still lists
NCT03118297 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03118297 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03118297's enrollment target sits among peer trials
65 1797th of 2000 higher than 202 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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