Last updated: 11/07/2018 07:13:33

Drug Use Investigation for AVOLVE(BPH)

GSK study ID
114125
See study documents
Clinicaltrials.gov ID
NCT01376284
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Drug Use Investigation for AVOLVE(BPH)
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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

Timeframe: 1 year

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Dutasteride
    • Enrollment:
    1000
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Yukiko Yanagita, Rie Otake, Terufumi Hara, Pascal Yoshida .Safety and Effectiveness of Dutasteride (AvolveĀ® Capsules) in Patients with Benign Prostatic Hyperplasia (BPH): Results of Drug Use Investigation.Jap J Urol Surg.2015;28(7):1271-1280
    Medical condition
    Prostatic Hyperplasia
    Product
    dutasteride
    Collaborators
    Not applicable
    Study date(s)
    December 2010 to June 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Male
    Age
    15+ years
    Accepts healthy volunteers
    No
    • Must be male subjects
    • Use dutasteride capsules for the first time
    • Subjects who is hypersensitivity to dutasteride or 5Ī± reductase inhibitor
    • Subjects with severe hepatic function disorder
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Must be male subjects
    • Use dutasteride capsules for the first time
    Exclusion criteria:
    • Subjects who is hypersensitivity to dutasteride or 5Ī± reductase inhibitor
    • Subjects with severe hepatic function disorder
    • Dutasteride capsules shall not be used to female or child

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2014-20-06

    Plain language summaries

    Not applicable. GSKā€™s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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