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Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

NCT00345969 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-02-22

Study results available
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Summary

The primary aim of this study is to determine, in hypogonadal older men with physical frailty, whether exercise training combined with testosterone replacement therapy can improve skeletal muscle strength, and lean mass, to a greater degree than exercise training alone.

Conditions

  • Physical Frailty
  • Hip Fracture
  • Elective Hip Replacement
  • Hypogonadism

Interventions

DRUG

Transdermal Testosterone gel (1%)

Transdermal testosterone replacement therapy with Androgel(TM). Daily application of gel at 5 mg, 7.5 gm, or 10 gm for six months. Target serum total testosterone level between 500-900 ng/dl.

BEHAVIORAL

Supervised exercise training

Supervised exercise training performed on site at academic medical center exercise facility. Exercise training consisted of 2 months of flexibility, balance, treadmill walking, and physical therapy-type exercises, followed by 4 months of progressive resistance training.

Sponsors & Collaborators

  • Solvay Pharmaceuticals

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Ellen F. Binder, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2009-02-28
Completion
2009-08-31

Countries

  • United States

Study Locations

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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 NCT00345969 on ClinicalTrials.gov