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Economic Analyses of the REDUCE Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01337258
First Posted: April 18, 2011
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose

The objective of this project is to conduct a retrospective economic analysis of the use of dutasteride for the prevention of prostate cancer based on data from the REDUCE clinical trial. REDUCE is a 4-year, phase 3, randomized, double-blind, parallel assignment clinical trial of the use of dutasteride compared with no chemopreventive treatment.

The REDUCE trial was a four-year, international, multicenter, randomized, double-blind, placebo-controlled, parallel group study. There were 790 investigators in 42 countries.


Condition Intervention
Neoplasms, Prostate Benign Prostatic Hyperplasia Cancer Drug: Dutasteride Drug: Placebo

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Economic Analyses Alongside the REDUCE Clinical Trial

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Cost of treating prostate-related events [ Time Frame: REDUCE clinical trial, 4 year time period ]
    Prostate Related Events include Benign Prostatic Hyperplasia (BPH), Prostate Cancer (PCA) and Prostatitis


Enrollment: 1
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Men at increased risk for Prostate Cancer (PCA) Drug: Dutasteride
dutasteride 0.5mg daily.
Other Name: Placebo
Drug: Placebo
Men taking placebo daily

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Men at increase risk for prostate cancer ages 50-75 who were enrolled in the REDUCE study
Criteria

Inclusion Criteria:

  • Men aged 50 to 75 years
  • 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:

  • Principal exclusion criteria were more than one prior prostate biopsy
  • high-grade intraepithelial neoplasia (HG-PIN) or atypical small acinar proliferation (ASAP) on the pre-entry prostate biopsy
  • a prostate volume >80 ml, previous prostate surgery
  • International Prostate Symptom Score (IPSS) ≥25 or ≥20 if already on alpha-blocker therapy for BPH
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337258


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01337258     History of Changes
Other Study ID Numbers: 113979
First Submitted: March 4, 2010
First Posted: April 18, 2011
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by GlaxoSmithKline:
cost effectiveness
dutasteride
elevated risk population
Prostate cancer
prevention

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Prostatic Neoplasms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Dutasteride
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs


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