Drug Use Investigation for AVOLVE(BPH)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Prostatic Hyperplasia

Treatments: Drug: Dutasteride

Study type: Observational

Funder types: Industry

Identifiers

NCT01376284

114125

Details and patient eligibility

About

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.

Enrollment: 1,000 patients

Sex: Male

Ages: 15+ years old

Volunteers: No 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

Trial design

1,000 participants in 1 patient group

Subjects prescribed dutasteride capsules

Description:

Subjects with BPH prescribed dutasteride capsules during study period

Treatment:

Drug: Dutasteride