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Testosterone Replacement Therapy in Chronic Spinal Cord Injury

NCT00266864 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2017-11-01

Study results available
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Summary

It has long been recognized that co-morbidity associated with multiple metabolic syndrome, such as adverse body composition, insulin resistance and autonomic nervous system impairment, may lead to significant increase in cardiovascular morbidity and mortality. It is unclear whether the co-morbidity evident in this population are due directly to their immobility or are the result of unfavorable changes in their underlying hormonal milieu. The purpose of this study is to determine the effect of testosterone replacement therapy in hypogonadal males on:

body composition, i.e. lean tissue and fat mass, glucose tolerance, resting energy expenditure, autonomic-cardiovascular integrity, muscular strength, psychological assessment

Conditions

  • Spinal Cord Injury
  • Hypogonadism

Interventions

DRUG

Testosterone Transdermal System (Androderm 5 mg patch)

Testosterone Transdermal System (Androderm 5 mg patch)

Sponsors & Collaborators

  • Kessler Institute for Rehabilitation

    collaborator INDUSTRY

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • William Bauman, MD · VA Medical Center, Bronx

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2012-08-31
Completion
2012-12-31

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 NCT00266864 on ClinicalTrials.gov