NCT01071915

Efficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate Cancer

An Open-label, Multi-Centre Trial, Bridging Efficacy and Safety of Degarelix One-Month Dosing Regimen in Korean Patients With Prostate Cancer Requiring Androgen Ablation Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multi-centre single arm trial to investigate efficacy and safety of degarelix in Korean patients with prostate cancer for bridging between CS21 trial (NCT00295750) results.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Degarelix 240/80 mg	The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-02-19
• Last updated: 2013-02-12
• Results posted: 2013-02-12

Locations

11 sites across 1 country: South Korea