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TRADE-Testosterone Replacement and Dutasteride Effectiveness

NCT00194675 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2017-12-05

Study results available
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Summary

The purpose of this research study is to determine whether the combination of the male hormone testosterone \[T\] in gel form and the oral drug dutasteride \[D\], used to shrink large prostate glands can safely reduce the size of the prostate gland and symptoms of prostate enlargement (called benign prostatic hyperplasia \[BPH\]) compared to T treatment alone in men with low testosterone (called hypogonadism).

Conditions

  • Hypogonadism
  • Benign Prostatic Hyperplasia

Interventions

DRUG

Dutasteride

Dutasteride 0.5 mg orally daily

DRUG

Testosterone gel

Testosterone gel 7.5 g daily topical

DRUG

Placebo dutasteride

placebo dutasteride orally daily

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Seattle Institute for Biomedical and Clinical Research

    collaborator OTHER

  • VA Office of Research and Development

    collaborator FED

  • Solvay Pharmaceuticals

    collaborator INDUSTRY

  • University of Washington

    lead OTHER

Principal Investigators

  • Alvin M Matsumoto, MD · VA Puget Sound Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2010-04-30
Completion
2010-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00194675 on ClinicalTrials.gov