At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 386 enrolled
Drug / intervention
Degarelix 80 mg / Degarelix 80 mg +3 moredrug
Likely dose
Degarelix 80 mg / Degarelix 80 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, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
In Brief
A Phase 3 clinical trial evaluating Degarelix 80 mg / Degarelix 80 mg, Degarelix 160 mg / Degarelix 160 mg, and 2 other interventions for Prostate Cancer. Completed, enrolled 386 participants across 69 sites in 12 countries.
Detailed Summary
Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.
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
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2007
First PostedMar 2007
Primary CompletionOct 2011
Study CompletionDec 2011
TodayJul 2026
First PostedMar 26, 2007
Enrollment StartMar 1, 2007
Primary CompletionOct 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 19.3 years ago
Interventions
Degarelix 80 mg / Degarelix 80 mgdrug
Degarelix 160 mg / Degarelix 160 mgdrug
Leuprolide 7.5 mg / Degarelix 80 mgdrug
Leuprolide 7.5 mg / Degarelix 160 mgdrug