At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 157 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 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 157 participants across 28 sites.
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
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMar 2014
First PostedMay 2014
Primary CompletionMar 2016
TodayJul 2026
First PostedMay 26, 2014
Enrollment StartMar 31, 2014
Primary CompletionMar 29, 2016
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 12.1 years ago
Interventions
Ulipristal acetate (UPA)drug
UPA tablet
Placebodrug
Matching placebo tablet.