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A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas

NCT02147158 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2019-06-04

Study results available
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Summary

This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids

Conditions

  • Leiomyoma
  • Uterine Hemorrhage

Interventions

DRUG

Ulipristal acetate (UPA)

Ulipristal acetate (UPA) tablet.

DRUG

Placebo

Matching placebo tablet.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Anna Chan · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-29
Primary Completion
2016-11-24
Completion
2016-11-24
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02147158 on ClinicalTrials.gov