At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 241 enrolled
Drug / intervention
PGL4001 (ulipristal) and iron +2 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 III, Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of PGL4001 (Ulipristal) Versus Placebo for Pre-Operative Treatment of Symptomatic Uterine Myomas
In Brief
A Phase 3 clinical trial evaluating PGL4001 (ulipristal) and iron and PGL4001 matching placebo and iron for Uterine Myomas. Completed, enrolled 241 participants across 38 sites in 6 countries.
Detailed Summary
This trial will assess the efficacy and safety of PGL4001 with concomitant iron administration versus placebo with concomitant iron administration, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine Myomas
CountriesCzechia, Hungary, India, Romania, Russia, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2008
Enrollment StartOct 2008
Primary CompletionMar 2010
Study CompletionAug 2010
TodayJul 2026
First PostedSep 19, 2008
Enrollment StartOct 1, 2008
Primary CompletionMar 1, 2010
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.8 years ago
Interventions
PGL4001 (ulipristal) and irondrug
tablets
PGL4001 matching placebo and irondrug
tablets
PGL4001 (ulipristal) and irondrug
Tablets