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NCT02147197 · ClinicalTrials.gov registry record · Phase 3
A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas
A Phase 3 study of Leiomyoma and Uterine Hemorrhage, sponsored by Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 157
- Enrollment target
- 20
- Study locations
NCT02147197: Completed Phase 3 study of Leiomyoma and Uterine Hemorrhage, sponsored by Allergan.
NCT02147197 is a Phase 3 study of Leiomyoma and Uterine Hemorrhage that has completed, run by Allergan. The registered enrollment target is 157 participants, above the 86-participant average among 8 other Leiomyoma trials with a reported enrollment target (83% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02147197, a Phase 3 study of Leiomyoma and Uterine Hemorrhage, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 157 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids
Primary Outcome
Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e. no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in the 12-week Treatment Period.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ulipristal acetate (UPA)
Study Locations (20)
Florida
- Watson Investigational Site 106 - Clearwater
- Watson Investigational Site 122 - Lake Worth
- Watson Investigational Site 130 - Miami
- Watson Investigational Site 105 - New Port Richey
- Watson Investigational Site 104 - Orlando
- Watson Investigational Site 120 - Orlando
Georgia
- Watson Investigational Site 103 - Atlanta
- Watson Investigational Site 123 - Atlanta
- Watson Investigational Site 111 - Augusta
Colorado
- Watson Investigational Site 112 - Denver
- Watson Investigational Site 115 - Lakewood
Arizona
- Watson Investigational Site 125 - Tucson
California
- Watson Investigational Site 102 - San Diego
Connecticut
- Watson Investigational Site 116 - Milford
District of Columbia
- Watson Investigational Site 114 - Washington D.C.
Idaho
- Watson Investigational Site 124 - Idaho Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2014-03-31 |
| Est. Completion | 2016-03-29 |
| Phase | Phase 3 |
What the finished NCT02147197 record still lists
NCT02147197 is an interventional study that assigns participants to a tested intervention. The registered 157 participants enrollment target is mid-sized for trials with a published cap, above the 86-participant average among 8 other Leiomyoma trials with a reported enrollment target (83% higher).
The record links to 2 conditions, with Leiomyoma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02147197 names 20 study sites across 12 states, led by Florida, Georgia, Colorado.
Frequently Asked Questions
What is clinical trial NCT02147197 about?
NCT02147197 is a clinical study titled "A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas". This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids
What is the current status of trial NCT02147197?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 157 participants. The study started on 2014-03-31. Estimated completion is 2016-03-29.
What conditions does trial NCT02147197 study?
This clinical trial studies the following conditions: Leiomyoma, Uterine Hemorrhage.
What interventions are being tested in trial NCT02147197?
The interventions under investigation include: Placebo (DRUG), Ulipristal acetate (UPA) (DRUG).
Who is sponsoring clinical trial NCT02147197?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02147197 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02147197's enrollment target sits among peer trials
157 1st of 8 higher than 8 of 8 other Leiomyoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leiomyoma 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.
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