Last updated: 11/03/2018 16:41:10

Evaluating the impact of early versus delayed 5 alpha reductase inhibitor treatment on the risk of emergent surgery in men with benign prostatic hyperplasia

GSK study ID
114461
See study documents
Clinicaltrials.gov ID
NCT01332487
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Evaluating the impact of early versus delayed 5 alpha reductase inhibitor treatment on the risk of emergent surgery in men with benign prostatic hyperplasia
Trial description: This retrospective study aims to assess the impact of early vs delayed 5-alpha-reductase inhibitor (5ARI) therapy in patients with BPH on alpha-blocker (AB) therapy and the risk of acute urinary retention (AUR), prostate-related surgery, and emergency surgery (defined as prostate surgery occurring within 30 days of AUR). 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 who experienced progression of disease

Timeframe: Up to 5 months

Secondary outcomes:

Number of Participants with the Indicated Time between Acute Urinary Retention and Subsequent Surgery

Timeframe: 6 months

Interventions:
Drug: 5ARI + AB
Enrollment:
4068
Observational study model:
Cohort
Primary completion date:
2010-11-08
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Prostatic Hyperplasia
Product
dutasteride
Collaborators
Not applicable
Study date(s)
August 2010 to August 2010
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Male
Age
50+ years
Accepts healthy volunteers
No
  • Male
  • aged 50 years or older
  • prostate or bladder cancer during the study period
  • any prostate-related surgical procedure within 5 months of the index prescription date
Inclusion and exclusion criteria
Inclusion criteria:
  • Male
  • aged 50 years or older
  • diagnostic claim for BPH
  • prescription claim for an AB and a 5ARI in the observation period (5ARI must occur within a 6-month window after the AB).
  • continuously eligible for 6 months prior to and 12 months after index prescription date
Exclusion criteria:
  • prostate or bladder cancer during the study period
  • any prostate-related surgical procedure within 5 months of the index prescription date
  • prescription claim for finasteride 1 mg for male pattern baldness during the study period
  • 5ARI therapy prior to initiation of AB therapy

Trial location(s)

No location data available.

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
Finalized
Actual primary completion date
2010-11-08
Actual study completion date
2010-11-08

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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