CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 133 enrolled
Drug / intervention
Degarelix +1 moredrug
Likely dose
Degarelix 240 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.

Search/NCT00468286
NCT00468286Phase 2Completed

An Open-Label, Multi-Centre, Randomised Parallel-Group Dose-Finding Study, Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy

Ferring Pharmaceuticals·interventional·Posted May 2, 2007·Updated Mar 23, 2011

In Brief

A Phase 2 clinical trial evaluating Degarelix for Prostate Cancer. Completed, enrolled 133 participants across 29 sites in 5 countries.

Detailed Summary

The study will have two treatment groups, evaluating two Degarelix doses. First dose is the initial dose followed by a maintenance dose given every three months. The initial dose given to suppress the testosterone level and the three month maintenance dose to maintain the suppressed testosterone level over one year of treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesCanada, Czechia, Hungary, Romania, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2, 2007
Enrollment StartMay 1, 2007
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.2 years ago

Interventions

Degarelixdrug

Experimental Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.

Degarelixdrug

Experimental Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.