Last updated: 11/07/2018 07:45:17
Benign Prostatic Hypertrophy Treatment Patterns & Outcomes: Marketscan
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2010-07-05
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)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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