Drug Use Investigation for AVOLVE(BPH)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2014-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Prostatic Hyperplasia

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects prescribed dutasteride capsules

Subjects with BPH prescribed dutasteride capsules during study period

Dutasteride

Intervention Type DRUG

Collection of safety data

Interventions

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Dutasteride

Collection of safety data

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No