At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 60 enrolled
Drug / intervention
Placebo +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 Phase 2, Multi-Center, Three-Arm, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Endometriosis
In Brief
A Phase 2 clinical trial evaluating Placebo and Telapristone acetate for Endometriosis. Completed, enrolled 60 participants across 10 sites.
Detailed Summary
The primary purpose of this study is to determine the safety and efficacy of two oral doses of telapristone acetate administered to premenopausal women with pelvic pain associated with endometriosis confirmed within the last seven years and using prescription analgesics for symptomatic pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometriosis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2012
Enrollment StartMay 2013
Primary CompletionMar 2017
TodayJul 2026
First PostedNov 19, 2012
Enrollment StartMay 2, 2013
Primary CompletionMar 15, 2017
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 13.6 years ago
Interventions
Placebodrug
Placebo matching capsules, orally, once daily for 18 weeks.
Telapristone acetatedrug
Telapristone acetate capsules, orally once daily for 18 weeks.