NCT00451958

A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 386 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Degarelix 80 mg / Degarelix 80 mg
DRUG	Degarelix 160 mg / Degarelix 160 mg
DRUG	Leuprolide 7.5 mg / Degarelix 80 mg
DRUG	Leuprolide 7.5 mg / Degarelix 160 mg

Timeline

• Start date: 2007-03-01
• Primary completion: 2011-10-01
• Completion: 2011-12-01
• First posted: 2007-03-26
• Last updated: 2013-03-21
• Results posted: 2013-03-21

Locations

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