Last updated: 11/07/2018 07:45:17

Benign Prostatic Hypertrophy Treatment Patterns & Outcomes: Marketscan

GSK study ID
114462
See study documents
Clinicaltrials.gov ID
NCT01323998
See results summary
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: Evaluating the treatment patterns in men with benign prostatic hypertrophy (Marketscan database study)
Trial description: This retrospective study aims to assess treatment patterns within 1 year of initiating BPH treatment, including 5-alpha-reductase inhibitor (5ARI) monotherapy, alpha-blocker (AB) monotherapy, early combination therapy, and delayed combination therapy. The MarketScan database will be utilized for this study (2000-2008)
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants by treatment cohort with and without a benign prostatic hypertrophy (BPH) diagnosis

Timeframe: 4 years

Secondary outcomes:
Not applicable
Interventions:
  • Drug: 5ARI
  • Drug: AB
    • Enrollment:
    35032
    Primary completion date:
    2010-07-05
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Kruep EJ, Goodwin BB, Chaudhari S. Evaluation of Recent Trends in Treatment Patterns Among Men with Benign Prostatic Hyperplasia. Am J Mens Health. 2013;7(3):214-219.
    Medical condition
    Prostatic Hyperplasia
    Product
    dutasteride
    Collaborators
    Not applicable
    Study date(s)
    April 2010 to May 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Male
    Age
    50+ years
    Accepts healthy volunteers
    No
    • Male
    • aged 50 years or older
    • diagnosis of prostate or bladder cancer during the study period
    • any prostate-related surgical procedure within 1 month of the index prescription date
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Male
    • aged 50 years or older
    • a diagnostic claim for BPH
    • at least one prescription claim for a 5ARI or AB in the enrollment period
    • continuous eligibility for 6 months prior to and 12 months after index prescription date
    Exclusion criteria:
    • diagnosis of prostate or bladder cancer during the study period
    • any prostate-related surgical procedure within 1 month of the index prescription date
    • prescription claim for finasteride 1 mg for male pattern baldness during the study period

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    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
    2010-07-05
    Actual study completion date
    2010-07-05

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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