Pharmacovigilance Study To Evaluate Safety Of AVODART In Subjects With Benign Prostate Hyperplasia
This study has 4 phases: screening phase (visit 1), treatment phase (visit 2 - 6 mths after treatment initiation), and end of treatment phase (visit 3 - end of year 1). Only in the case a serious adverse event (SAE) arises, will there be a follow up phase (visit 4).
Benign Prostatic Hyperplasia
|Study Design:||Time Perspective: Prospective|
|Official Title:||A Pharmacovigilance Study to Evaluate Safety of AVODART (Dutasteride) Administration 0,5 mg Once Daily, for 52 Weeks, in Subjects With Benign Prostate Hyperplasia|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593593
|Study Director:||GSK Clinical Trials, MD||GlaxoSmithKline|