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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Benign Prostatic Hyperplasia

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline


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).

Clinical Details

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

Study design: Time Perspective: Prospective


Minimum age: N/A. Maximum age: N/A. Gender(s): Male.


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

Locations and Contacts

Additional Information

Starting date: December 2004
Last updated: October 13, 2008

Page last updated: August 20, 2015

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