Drug Use Investigation for AVOLVE(BPH)

Completed

• Conditions: Prostatic Hyperplasia
• Interventions: Drug: Dutasteride

• Registration Number: NCT01376284
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The study is designed to investigate the safety and efficacy of dutasteride capsules 0.5 mg collected from the required number of Japanese subjects with benign prostatic hyperplasia (BPH) in order to identify concerns or problems, if any, about the efficacy and safety of its use at post-marketing clinical settings.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-16
• Study First Posted: 2011-06-20
• Primary Completion: 2013-10
• Study Completion: 2014-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-24
• Last Update Posted: 2014-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1000

Inclusion Criteria

• Must be male subjects
• Use dutasteride capsules for the first time

Exclusion Criteria

• Subjects who is hypersensitivity to dutasteride or 5α reductase inhibitor
• Subjects with severe hepatic function disorder
• Dutasteride capsules shall not be used to female or child

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects prescribed dutasteride capsules	Dutasteride	Subjects with BPH prescribed dutasteride capsules during study period

Primary Outcome Measures

Name	Time	Method
The number of adverse events in Japanese subjects with BPH treated with dutasteride capsules	1 year