Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1 participants
OBSERVATIONAL
2010-01-31
2010-07-31
Brief Summary
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The REDUCE trial was a four-year, international, multicenter, randomized, double-blind, placebo-controlled, parallel group study. There were 790 investigators in 42 countries.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Men at increased risk for Prostate Cancer (PCA)
Dutasteride
dutasteride 0.5mg daily.
Placebo
Men taking placebo daily
Interventions
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Dutasteride
dutasteride 0.5mg daily.
Placebo
Men taking placebo daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* serum prostate-specific antigen (PSA) ≥2.5 ng per milliliter and ≤10 ng per milliliter (men aged 50-60 years) or ≥3.0 ng per milliliter and ≤10 ng per milliliter (men aged \>60 years)
* single, negative prostate biopsy (6-12 cores) within 6 months prior to enrollment (independent of the study)
Exclusion Criteria
* a prostate volume \>80 ml, previous prostate surgery
* International Prostate Symptom Score (IPSS) ≥25 or ≥20 if already on alpha-blocker therapy for BPH
50 Years
75 Years
MALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Other Identifiers
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113979
Identifier Type: -
Identifier Source: org_study_id
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