NCT00295750

The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 620 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study was a three-arm, active-control, multi-centre, parallel group study.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Degarelix	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.
DRUG	Degarelix	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.
DRUG	Leuprolide 7.5 mg	Leuprolide (Lupron Depot) 7.5mg IM (in the muscle every 28 days starting at day 0.

Timeline

• Start date: 2006-02-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2006-02-24
• Last updated: 2012-12-19
• Results posted: 2009-04-16

Locations

35 sites across 12 countries: United States, Canada, Czechia, Germany, Hungary, Mexico, Netherlands, Puerto Rico, Romania, Russia, Ukraine, United Kingdom