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

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ClinicalTrials.gov Identifier: NCT00593593

Recruitment Status : Completed

First Posted : January 15, 2008

Last Update Posted : October 15, 2008

Sponsor:

Information provided by:

GlaxoSmithKline

Study Description

Brief Summary:

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).

Condition or disease
Benign Prostatic Hyperplasia

Study Design

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Study Type :	Observational
Enrollment :	1000 participants
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
Study Start Date :	December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Enlarged Prostate (BPH)

Drug Information available for: Dutasteride

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593593

Sponsors and Collaborators

GlaxoSmithKline

Investigators

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Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

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Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00593593 History of Changes
Other Study ID Numbers:	104244 Avodart-pv/GR
First Posted:	January 15, 2008 Key Record Dates
Last Update Posted:	October 15, 2008
Last Verified:	October 2008

Keywords provided by GlaxoSmithKline:


benign prostate hyperplasia Dutasteride pharmacovigilance

Additional relevant MeSH terms:

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Dutasteride Prostatic Hyperplasia Hyperplasia Pathologic Processes Prostatic Diseases Genital Diseases, Male 5-alpha Reductase Inhibitors	Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

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