Testosterone Replacement Therapy in Chronic Spinal Cord Injury

Condition(s) targeted: Spinal Cord Injury; Hypogonadism

Intervention: Testosterone Transdermal System (Androderm 5 mg patch) (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Department of Veterans Affairs

Official(s) and/or principal investigator(s):
William Bauman, MD, Principal Investigator, Affiliation: VA Medical Center, Bronx

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

Official title: Testosterone Replacement Therapy in Chronic Spinal Cord Injury

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM)

Secondary outcome: Resting Energy Expenditure

Detailed description: This study is 24 months in duration. Men who have consented to pre-screening serum testosterone draw and are found to have total testosterone levels averaging ≤ 11. 3 nmol/l will start testosterone replacement therapy after a 6-month baseline period. Once treatment begins subjects will place a testosterone replacement patch (5 or 10 mg/day) on various sites of the body daily. Subjects will visit the lab after 2,6, 12, and 18 months of therapy for testing; however they will stop taking the patch at the 12 month visit. If needed, a steroid cream will be provided to the subjects should any skin irritations occur. If the patch causes persistent skin irritations, despite use of the steroid cream, then a testosterone gel may be used. Detailed instructions and precautions using the gel are outlined in the consent form and will be reviewed with the subject. Those men who have consented to pre-screening serum testosterone and are found to have normal levels of total testosterone (testosterone total ≥ 11. 4 nmol/l) are eligible to participate as a control subject for the full 24-month period of the study. These subjects visit the lab at baseline (BL), 12 and 24 months for the same testing as those in the treatment group.

Minimum age: 18 Years. Maximum age: 49 Years. Gender(s): Male.

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

Kessler Institute for Rehabilitation, West Orange, New Jersey 07052, United States

James J. Peters VA Medical Center, Bronx, New York 10468, United States

Click here for more information about this study: Testosterone Replacement Therapy in Chronic Spinal Cord Injury

Starting date: August 2003
Last updated: April 8, 2014