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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364

Outcome Description:

Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone <=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Clinical Development Support

Investigator Role:

Study Director

Investigator Affiliation:

Ferring Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

FE200486 CS21

NCT ID:

NCT00295750

Start Date:

February 2006

Completion Date:

October 2007

Related Keywords:

• Prostate Cancer
• Prostate Cancer
• Prostatic Neoplasms