Drug Use Investigation for AVOLVE(BPH)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01376284

Enrollment

1000

Registered

2011-06-20

Start date

2010-12-31

Completion date

2014-06-30

Last updated

2014-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Hyperplasia

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.

Interventions

DRUGDutasteride

Collection of safety data

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

15 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026