Drug Use Investigation for AVOLVE(BPH)

GlaxoSmithKline1,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Prostatic Hyperplasia

Interventions

DutasterideDRUG

Collection of safety data

Eligibility

Sex: MALEMin age: 15 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 1 year

Data from ClinicalTrials.gov

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