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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
NCT02147197 · View on ClinicalTrials.gov ↗
Study Summary
This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02147197
The ClinicalTrials.gov registry entry for NCT02147197 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 157 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allergan, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02147197 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, Georgia, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02147197?
The interventions under investigation include: Placebo (DRUG), Ulipristal acetate (UPA) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02147197?
This trial is sponsored by Allergan, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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