At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 432 enrolled
Drug / intervention
Ulipristal acetate (UPA) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the Intermittent Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas
In Brief
A Phase 3 clinical trial evaluating Ulipristal acetate (UPA) and Placebo for Leiomyoma and Uterine Hemorrhage. Completed, enrolled 432 participants across 63 sites in 2 countries.
Detailed Summary
This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeiomyoma, Uterine Hemorrhage
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJan 2014
First PostedMay 2014
Primary CompletionNov 2016
TodayJul 2026
First PostedMay 26, 2014
Enrollment StartJan 29, 2014
Primary CompletionNov 24, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.1 years ago
Interventions
Ulipristal acetate (UPA)drug
Ulipristal acetate (UPA) tablet.
Placebodrug
Matching placebo tablet.