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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Benign Prostatic Hyperplasia

Study type: Observational

Funder types: Industry

Identifiers

NCT00593593

104244

Avodart-pv/GR

Details and patient eligibility

About

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).

Sex: Male

Volunteers: No Healthy Volunteers

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