CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 137 enrolled
Drug / intervention
Degarelixdrug
Likely dose
Degarelix subcutaneous injection every 28 daysAI-extracted
Key inclusion· 1
  • ✓Completed the FE200486 CS12 study
Key exclusion· 1
  • ✕Withdrawn from the FE200486 CS12 study

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00215683
NCT00215683Phase 3Completed
CompareCT.gov

An Open-Label, Multi-Centre, Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer.

Ferring Pharmaceuticals·interventional·Posted Sep 22, 2005·Updated Apr 1, 2015

In Brief

A Phase 3 clinical trial evaluating Degarelix for Prostate Cancer. Completed, enrolled 137 participants across 34 sites in 7 countries.

Detailed Summary

This was an extension study for the study FE200486 CS12 (NCT00819156). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.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 (including one year in the main study).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesBelgium, Germany, Hungary, Netherlands, Romania, Russia, South Africa
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartFeb 1, 2005
Primary CompletionOct 1, 2009
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 20.8 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.