At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 301 enrolled
Drug / intervention
PGL4001 +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 III, Randomised, Parallel Group, Double-blind, Double-dummy, Active Comparator-controlled, Multicenter Study to Assess the Efficacy and Safety of PGL4001 vs GnRH-agonist for Pre-operative Ttt of Symptomatic Uterine Myomas
In Brief
A Phase 3 clinical trial evaluating PGL4001 and leuprorelin for Uterine Myomas. Completed, enrolled 301 participants across 46 sites in 9 countries.
Detailed Summary
This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, 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
CountriesAustria, Belgium, France, Germany, Israel, Italy, Netherlands, Poland, Spain
Collaborators--
Timeline
Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2008
First PostedAug 2008
Primary CompletionJan 2010
Study CompletionJun 2010
TodayJul 2026
First PostedAug 25, 2008
Enrollment StartAug 1, 2008
Primary CompletionJan 1, 2010
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.9 years ago
Interventions
PGL4001drug
tablets
leuprorelindrug
solution for injection