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