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Clinical trial

A Study of the Efficacy and Safety of a Single Ulipristal Treatment Course for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas

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Last updated:1st Apr 2014

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


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas
Enrollment: 144
Study Start Date: April 2014
Study Completion Date: April 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
Ulipristal acetate 5 mg
- Experimental: Ulipristal acetate 10 mg
- Placebo Comparator: Placebo

Category Value
Study start date 2014-04-01

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