NCT00117312

Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Participants responding well in Study FE200486 CS06 (NCT00117949) were given the opportunity to continue treatment with degarelix under a clinical study until FE200486 was available on the market or until the study was discontinued. Study FE200486 CS06A was to provide knowledge of the long-term safety and tolerability of FE200486.

Detailed description

The data include participants from both the main study (FE200486 CS06; NCT00117949) and the extension study FE200486 CS06A.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Degarelix	One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.
DRUG	Degarelix	One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.
DRUG	Degarelix	One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.
DRUG	Degarelix	One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.

Timeline

• Start date: 2002-10-01
• Primary completion: 2005-11-01
• Completion: 2005-11-01
• First posted: 2005-07-06
• Last updated: 2011-05-23
• Results posted: 2009-03-20

Locations

12 sites across 1 country: United States