NCT00946920

A Trial of Degarelix in Patients With Prostate Cancer

An Open-Label, Multi-Centre, Randomised, Parallel-Arm One-Year Trial, Comparing the Efficacy and Safety of Degarelix Three-Month Dosing Regimen With Goserelin Acetate in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 859 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in patients with prostate cancer.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Degarelix	The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
DRUG	Goserelin acetate	The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2009-07-27
• Last updated: 2014-06-02
• Results posted: 2014-06-02

Locations

126 sites across 14 countries: United States, Belgium, Canada, Czechia, Finland, Germany, Hungary, Mexico, Netherlands, Poland, Romania, Russia, Ukraine, United Kingdom