Drug Use Investigation for AVOLVE(BPH)

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.

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Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Urogenital Diseases

Age range

15 year and older

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dutasteride

Drug

Collection of safety data

Primary outcomes

The number of adverse events in Japanese subjects with BPH treated with dutasteride capsules

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2014
First posted: Jun 20, 2011
Registry last updated: Jul 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed