Testosterone Replacement Therapy in Chronic Spinal Cord Injury

Completed · Phase 2/Phase 3

Conditions studied: Spinal Cord Injury, Hypogonadism

In brief

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

Key facts

Study ID

NCT00266864

Run by

VA Office of Research and Development

People needed

31

Starts

2003-08-01

Expected to finish

2012-12-01

Last updated by the study team

2017-11-01

Who can join

Age: 18 and older, up to 49. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Males 18-49 years of age
• Chronic spinal cord injury
• Normal prostate specific antigen levels and digital rectal exam
• No known cardiovascular disease
• Subjects with total testosterone > 4 ng/ml
• Subjects with total testosterone > 4 ng/ml

You may not qualify if…

• Females
• Known coronary heart and/or artery disease, diabetes mellitus
• Previous or current cancer
• Current or previous anabolic steroid use
• Acute inter-current illness
• Abnormal liver function test (>1.5 times normal values) at baseline
• Prostate specific antigen above normal
• Abnormal digital rectal exam at baseline suggestive of malignancy
• Current alcohol or drug abuse
• Significant psychological disorders

Where it is running

• Kessler Institute for Rehabilitation — West Orange, New Jersey, United States
• James J. Peters VA Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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