A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy
NCT00451958 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 386
Last updated 2013-03-21
Summary
Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.
Conditions
Interventions
- DRUG
-
Degarelix 80 mg / Degarelix 80 mg
- DRUG
-
Degarelix 160 mg / Degarelix 160 mg
- DRUG
-
Leuprolide 7.5 mg / Degarelix 80 mg
- DRUG
-
Leuprolide 7.5 mg / Degarelix 160 mg
Sponsors & Collaborators
-
Ferring Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Clinical Development Support · Ferring Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-03-31
- Primary Completion
- 2011-10-31
- Completion
- 2011-12-31
Countries
- United States
- Canada
- Czechia
- Germany
- Hungary
- Mexico
- Netherlands
- Puerto Rico
- Romania
- Russia
- Ukraine
- United Kingdom
Study Locations
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