Last updated: 01/30/2020 10:40:06

Meta analysis of the efficacy and tolerability of dutasteride in BPH treatment

GSK study ID
116764
See study documents
Clinicaltrials.gov ID
Not applicable
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: Meta analysis of the efficacy and tolerability of dutasteride in BPH treatment
Trial description: To perform a meta-analysis of published data on the efficacy and tolerability of dutasteride in BPH treatment. The data of finasteride will be also included in the analysis to provide a comparison.
Primary endoint: Improvement of symptom index
Secondary endpoint: Improvement of maximal urinary flow
Improvement of Quality of Life
Change of Prostate volume
Safety and tolerability
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

IPSS

Timeframe: 6 months

Secondary outcomes:

Qmax

Timeframe: 6 months

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2014-03-03
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Secondary prevention of long-term organ damage
Product
dutasteride
Collaborators
Not applicable
Study date(s)
November 2012 to March 2014
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Male
Age
55 - 80 Year
Accepts healthy volunteers
none
  • Medline, Embase and Cochrane Collaboration Library search through 1994 to 2011
  • Randomized clinical trials related to 5ARI therapy, which were lasted for more than 1 year
  • Abstract only
  • Articles could not provide detailed data in the content
Inclusion and exclusion criteria
Inclusion criteria:
  • Medline, Embase and Cochrane Collaboration Library search through 1994 to 2011 Randomized clinical trials related to 5ARI therapy, which were lasted for more than 1 year
Exclusion criteria:
  • Abstract only Articles could not provide detailed data in the content Review articles Duplicated publication Retrospective analysis

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Statistical analysis plan
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
2014-03-03
Actual study completion date
2014-03-03

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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