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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 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.

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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

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

FieldValue
Enrollment Target 157 participants
Start Date 2014-03-31
Est. Completion 2016-03-29
Phase Phase 3

Sponsor

Allergan

314 total trials

What the Registry Record Tells You About NCT02147197

The ClinicalTrials.gov registry entry for NCT02147197 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 157 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 86-participant average among 8 other Leiomyoma trials with a reported enrollment target (83% higher). The listed sponsor is Allergan, which has 314 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.