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TOM: Testosterone in Older Men With Sarcopenia

NCT00240981 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 209

Last updated 2017-02-23

Study results available
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Summary

The purpose of this study is to determine whether testosterone replacement in older men with low testosterone levels will increase muscle strength, improve physical performance and overall sense of well being, and reduce fatigue.

Conditions

Interventions

DRUG

Topical testosterone gel 1% (active formulation)

Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.

DRUG

Topical gel (placebo formulation)

Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Shalender Bhasin, MD · Boston University Medical Center, Section of Endocrinology, Diabetes, and Nutrition

  • Shehzad Basaria, MD · Boston University Medical Center, Section of Endocrinology, Diabetes, and Nutrition

  • Wildon Farwell, MD, MPH · VA Boston Healthcare System (Jamaica Plain Campus)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00240981 on ClinicalTrials.gov