NCT00819247

The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer

A Six Month, Multi-centre, Open-labelled, 1:1:1 Randomised, Parallel Group Study Investigating the Efficacy and Safety of Three Dose Regimens of FE 200486 in Prostate Cancer Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial was to select a dose of degarelix (FE 200486). Three groups of patients were treated for six months on different doses. The patients had blood samples taken and measured for Testosterone in order to determine the most efficient dose to provide fast and sustained castration. The patients came to the clinic for 16 visits and dependent on the blood sample results they were invited to return for additional blood samples on a two weekly basis.

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	Given as a subcutaneous injection.

Timeline

• Start date: 2001-03-01
• Primary completion: 2002-05-01
• Completion: 2002-08-01
• First posted: 2009-01-08
• Last updated: 2023-11-09
• Results posted: 2009-03-31

Locations

16 sites across 1 country: United Kingdom