Status:
COMPLETED
Effects On Dihydrotestosterone Regulated Gene Expression In Benign Prostatic Hyperplasia Or Prostate Cancer
Lead Sponsor:
GlaxoSmithKline
Conditions:
Benign Prostatic Hyperplasia
Prostate Cancer
Eligibility:
MALE
50+ years
Phase:
PHASE4
Brief Summary
Dutasteride is used in the treatment of benign prostate enlargement (BPH).It inhibits conversion of testosterone (T) into the more potent dihydrotestosterone (DHT) to stop prostate (and possibly prost...
Detailed Description
A randomized, open-label, parallel-group pilot study, to assess the pharmacodynamic effect on dihydrotestosterone regulated gene expression, longitudinally and in a dose dependent manner, of 0.5mg or ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Symptomatic BPH, or:
- Biopsy proven, localised (cT1 or cT2) prostate cancer scheduled for radical operation
- Able to swallow oral medication
- Exclusion criteria:
- Inability to void spontaneously (eg. dependence on catheter etc.)
- History of (prior) prostate cancer Previous prostatic surgery
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00375765
Start Date
April 1 2005
End Date
July 1 2007
Last Update
January 19 2017
Active Locations (2)
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1
GSK Investigational Site
Nijmegen, Netherlands, 6525 GA
2
GSK Investigational Site
Nijmegen, Netherlands, 6532 SZ