It has long been recognized that co-morbidities associated with the multiple metabolic syndrome (MMS), 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-morbidities evident in this population are due directly to their immobility or are the result of...
Date First Received: December 15, 2005
Last Updated: August 14, 2008
Verified by: Department of Veterans Affairs, August 2008
Clinical Trial Phase: Phase 2/Phase 3 | Start Date: August 2003
Overall Status: Recruiting
Estimated Enrollment: 50
Brief Summary
Official Title: “Testosterone Replacement Therapy in Chronic Spinal Cord Injury”
Condition Keyword(s):
Intervention(s):
It has long been recognized that co-morbidities associated with the multiple metabolic syndrome (MMS), 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-morbidities 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 sessment
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Study Primary Completion Date: December 2011
Detailed Clinical Trial 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 4 ng/ml will start testosterone replacement therapy after a 6-month baseline period. Once treatment begins subjects will place a testosterone replacement patch (5mg/day) on various sites of the body dailu. 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 irriations 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 (> 4ng/ml) 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.
Intervention(s) in this Clinical Trial
- Drug: Testosterone Replacement Therapy Patch 5mg daily
- Testosterone Replacement Therapy Patch 5mg daily
Arms, Groups and Cohorts in this Clinical Trial
- Other: 1
Outcome Measures for this Clinical Trial
Primary Measures
- Changes to body composition, metabolism, strength and cardiovascular autonomic control
- Time Frame: 12/31/2011
Safety Issue?: No
- Time Frame: 12/31/2011
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Males 18-60 years of age
- Chronic SCI
- Normal PSA levels and rectal exam
- No known cardiovascular disease
- 40 subjects with hypogonadism [low serum total testosterone (Ttotal 4 ng/ml)]
- 10 subjects with eugonadism (Ttotal > 4ng/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
- PSA above normal
- Abnormal DRE at baseline suggestive of malignancy
- Current alcohol or drug abuse
- Significant psychological disorders
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 60 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Department of Veterans Affairs
Overall Clinical Trial Officials and Contacts
William Bauman, MD Principal Investigator VA Medical Center, Bronx
Overall Contact: William Bauman, MD william.bauman@va.gov
Related Publications
Citations Reporting Results
Snyder PJ, Peachey H, Berlin JA, Rader D, Usher D, Loh L, Hannoush P, Dlewati A, Holmes JH, Santanna J, Strom BL. Effect of transdermal testosterone treatment on serum lipid and apolipoprotein levels in men more than 65 years of age. Am J Med. 2001 Sep;111(4):255-60.
Bauman WA, Spungen AM, Raza M, Rothstein J, Zhang RL, Zhong YG, Tsuruta M, Shahidi R, Pierson RN Jr, Wang J, et al. Coronary artery disease: metabolic risk factors and latent disease in individuals with paraplegia. Mt Sinai J Med. 1992 Mar;59(2):163-8.
Del Rio G, Carani C, Velardo A, Zizzo G, Procopio M, Coletta F, Marrama P, Ghigo E. Effect of testosterone replacement therapy on the somatotrope responsiveness to GHRH alone or combined with pyridostigmine and on sympathoadrenal activity in patients with hypogonadism. J Endocrinol Invest. 1995 Oct;18(9):690-5.
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00266864
Study ID Number: B2648C
ClinicalTrials.gov Identifier: NCT00266864
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
