NCT00819156

Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer

An Open-label, Randomised, Multi-centre, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Six Different Dosing Regimens in Patients With Prostate Cancer Treated for 12 Months

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing six different doses. The patients participating in the trial were treated with degarelix every month for a year. During the treatment the patients had to visit the clinic for investigations. Blood samples for testosterone, dihydrotestosterone, luteinizing hormone, follicle stimulating hormone, and Prostate Specific Antigen were taken and analysed throughout the trial.

Detailed description

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	degarelix	Degarelix was given as subcutaneous injections.

Timeline

• Start date: 2004-02-01
• Primary completion: 2005-06-01
• Completion: 2005-09-01
• First posted: 2009-01-08
• Last updated: 2023-11-30
• Results posted: 2009-03-31

Locations

39 sites across 8 countries: Belgium, Germany, Hungary, Netherlands, Poland, Romania, Russia, South Africa