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Drug Use Investigation for AVOLVE(BPH)

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

Condition(s) targeted: Prostatic Hyperplasia

Intervention: Dutasteride (Drug)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

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


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.

Clinical Details

Official title: Drug Use Investigation for AVOLVE(BPH)

Study design: Time Perspective: Prospective

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


Minimum age: 15 Years. Maximum age: N/A. Gender(s): Male.


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

Locations and Contacts

Additional Information

Starting date: December 2010
Last updated: July 24, 2014

Page last updated: August 20, 2015

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