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The Effect of Testosterone on Mood and Quality of Life

NCT00202462 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2008-10-01

No results posted yet for this study

Summary

We hypothesize that testosterone replacement will improve mood and quality of life in older men with low testosterone and mild depression. Study subjects will receive either testosterone gel or a placebo (inactive) gel for 12 weeks. Neither the subject or the investigator will know whether they are receiving placebo or testosterone gel. At the end of the initial 12 week period, all subjects will receive testosterone gel for 12 more weeks. Mood and quality of life measures will be obtained at baseline, at the end of the double-blind phase and at the end of the extension phase (when all subjects receive testosterone.)

Conditions

  • Gonadal Disorders
  • Depressive Disorder
  • Hypogonadism

Interventions

DRUG

Testosterone gel

Testosterone gel 7.5 gm qd

Sponsors & Collaborators

  • American Federation for Aging Research

    collaborator OTHER

  • VA Puget Sound Health Care System

    collaborator FED

  • Geriatric Research Education and Clinical Care

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • Solvay Pharmaceuticals

    collaborator INDUSTRY

  • Seattle Institute for Biomedical and Clinical Research

    lead OTHER

Principal Investigators

  • Molly M Shores, MD · University of Washington VA Puget Sound Health Care System, GRECC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2005-12-31
Completion
2006-11-30

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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 NCT00202462 on ClinicalTrials.gov