NCT00215657

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: 131 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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 (FDA regulated intervention is therefore ticked "YES"). The data include participants from both the main study (FE200486 CS07; NCT00818623) and the extension study FE200486 CS07A.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Degarelix	Degarelix 120 mg (20 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
DRUG	Degarelix	Degarelix 120 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
DRUG	Degarelix	Degarelix 160 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
DRUG	Degarelix	Degarelix 200 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
DRUG	Degarelix	Degarelix 200 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
DRUG	Degarelix	Degarelix 240 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
DRUG	Degarelix	Degarelix 240 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).
DRUG	Degarelix	Degarelix 320 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).

Timeline

• Start date: 2003-03-01
• Primary completion: 2006-03-01
• Completion: 2006-03-01
• First posted: 2005-09-22
• Last updated: 2011-05-20
• Results posted: 2009-06-12