At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 404 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
Degarelix 10 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 Dose-Finding, Multi-Centre, Double-Blind, Randomised, Parallel, Placebo-Controlled Trial to Investigate Efficacy and Safety of Degarelix in Men With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)
In Brief
A Phase 2 clinical trial evaluating Placebo, Degarelix 10 mg, and 2 other interventions for Lower Urinary Tract Symptoms (LUTS). Completed, enrolled 404 participants across 47 sites in 6 countries.
Detailed Summary
A dose-finding, multi-centre, double-blind, randomised, parallel, placebo-controlled trial to investigate efficacy and safety of degarelix in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLower Urinary Tract Symptoms (LUTS)
CountriesBelgium, Canada, Czechia, Italy, Poland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2009
Enrollment StartAug 2009
Primary CompletionMar 2011
Study CompletionJun 2011
TodayJul 2026
First PostedJul 28, 2009
Enrollment StartAug 1, 2009
Primary CompletionMar 1, 2011
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.9 years ago
Interventions
Placebodrug
Mannitol 50 mg/mL solution
Degarelix 10 mgdrug
10 mg degarelix, 40 mg/mL solution
Degarelix 20 mgdrug
20 mg degarelix, 40 mg/mL solution
Degarelix 30 mgdrug
30 mg degarelix, 40 mg/mL solution