At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 451 enrolled
Drug / intervention
PGL4001 5 mg +1 moredrug
Likely dose
PGL4001 5 mgfrom 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 III, Multicentre, Randomized, Double-blind Clinical Study, Investigating the Efficacy and Safety of Repeated 12-week Courses of Daily 5mg or 10mg Doses of PGL4001 for the Long-term Management of Symptomatic Uterine Fibroids
In Brief
A Phase 3 clinical trial evaluating PGL4001 5 mg and PGL4001 10 mg for Uterine Fibroids. Completed, enrolled 451 participants across 49 sites in 11 countries.
Detailed Summary
Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine Fibroids
CountriesBelgium, Czechia, France, Germany, Hungary, Italy, Latvia, Lithuania, Romania, Ukraine, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2012
First PostedJun 2012
Primary CompletionJan 2015
TodayJul 2026
First PostedJun 27, 2012
Enrollment StartJun 1, 2012
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 14.0 years ago
Interventions
PGL4001 5 mgdrug
PGL4001 5 mg daily administration
PGL4001 10 mgdrug
PGL4001 10mg daily administration