Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.
NCT00527488 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2015-05-04
Summary
This exploratory study will be conducted open label in a single investigational clinical unit. Altogether 52 patients with benign prostate hyperplasia (BPH) will be randomly assigned to receive 4 different treatments with degarelix.
Conditions
- BPH
Interventions
- DRUG
-
Degarelix
Two doses of 16 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days.
- DRUG
-
Degarelix
One dose of 32 mg administered as a single administration will be evaluated for 42 days.
- DRUG
-
Degarelix
Two doses of 32 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days.
- DRUG
-
Degarelix
One dose of 64 mg administered as a single administration will be evaluated for 42 days.
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
- 55 Years
- Max Age
- 75 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-10-31
- Primary Completion
- 2009-03-31
- Completion
- 2009-05-31
Countries
- Germany
Study Locations
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