At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 40 enrolled
Drug / intervention
Proellexdrug
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, 3 Arm, Randomized, Double-Blind Study to Evaluate the Safety, PK and Efficacy of Proellex® Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids
In Brief
A Phase 2 clinical trial evaluating Proellex for Uterine Fibroids. Completed, enrolled 40 participants across 2 sites.
Detailed Summary
To determine the safety, pharmacokinetics and efficacy of 4 doses (3, 6, 12, 24 mg) of Proellex in premenopausal women with uterine fibroids confirmed by ultrasound. Drug will be administered vaginally.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine Fibroids
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 2011
Enrollment StartFeb 2012
Primary CompletionDec 2012
Study CompletionJan 2013
TodayJul 2026
First PostedOct 13, 2011
Enrollment StartFeb 1, 2012
Primary CompletionDec 1, 2012
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.7 years ago
Interventions
Proellexdrug
vaginal suppository, daily, for 12 weeks