At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 57 enrolled
Drug / intervention
Degarelixdrug
Likely dose
Degarelix subcutaneous injection every 28 daysAI-extracted
Key inclusion· 1
- ✓Completed the parent study FE200486 CS14 through visit 22
Key exclusion· 1
- ✕Withdrawn from the parent study FE200486 CS14
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer
In Brief
A Phase 3 clinical trial evaluating Degarelix for Prostate Cancer. Completed, enrolled 57 participants across 22 sites in 2 countries.
Detailed Summary
This was an extension study for the study FE200486 CS14 (NCT00116779). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained. The study was terminated when all ongoing participants had been treated for at least 5 years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2005
First PostedJul 2005
Primary CompletionSep 2009
Study CompletionNov 2009
TodayJul 2026
First PostedJul 6, 2005
Enrollment StartMar 1, 2005
Primary CompletionSep 1, 2009
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 21.0 years ago
Interventions
Degarelixdrug
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study.