Pharmacovigilance Study To Evaluate Safety Of AVODART In Subjects With Benign Prostate Hyperplasia

A Pharmacovigilance Study to Evaluate Safety of AVODART (Dutasteride) Administration 0,5 mg Once Daily, for 52 Weeks, 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).

Inclusion Criteria:

• Subject should fulfil criteria for the subscription of AVODART as these are mentioned in the SPC
• Subject should be diagnosed with benign prostate hyperplasia
• Subject's prostate volume should be equal or greater than 30 cm3

Exclusion Criteria:

• Known hypersensitivity to any of the AVODART compounds
• Suffers from a serious illness which either is not properly controlled or as per investigator´s judgment could interfere with the subject´s compliance into the trial
• Receives treatment with enzyme inhibitors CYP3A4 and CYP3A5.
• History of severe liver failure