At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 620 enrolled
Drug / intervention
Degarelix +2 moredrug
Likely dose
Leuprolide 7.5 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.
An Open-label, Multi-Centre, Randomized, Parallel-group Study, Investigating the Efficacy and Safety of Degarelix One Month Dosing Regimens; 160 mg (40 mg/ml) and 80 mg (20mg/ml), in Comparison to LUPRON DEPOT® 7.5 mg in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
In Brief
A Phase 3 clinical trial evaluating Degarelix and Leuprolide 7.5 mg for Prostate Cancer. Completed, enrolled 620 participants across 35 sites in 12 countries.
Detailed Summary
The study was a three-arm, active-control, multi-centre, parallel group study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesCanada, Czechia, Germany, Hungary, Mexico, Netherlands, Puerto Rico, Romania, Russia, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2006
First PostedFeb 2006
Primary CompletionOct 2007
TodayJul 2026
First PostedFeb 24, 2006
Enrollment StartFeb 1, 2006
Primary CompletionOct 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 20.4 years ago
Interventions
Degarelixdrug
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days for 364 days.
Degarelixdrug
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days for 364 days.
Leuprolide 7.5 mgdrug
Leuprolide (Lupron Depot) 7.5mg IM (in the muscle every 28 days starting at day 0.