Testosterone Replacement Therapy in Chronic Spinal Cord Injury

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Collaborator: Kessler Institute for Rehabilitation
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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