Anabolic Therapies: New Hope for Treating Secondary Disabilities of SCI
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Purpose
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 assessment
| Condition | Intervention | Phase |
|---|---|---|
|
Hypogonadism Spinal Cord Injury |
Drug: Testosterone Replacement Therapy Patch 5mg daily |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Testosterone Replacement Therapy in Chronic Spinal Cord Injury |
- Changes to body composition, metabolism, strength and cardiovascular autonomic control [ Time Frame: 12/31/2013 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2003 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Arm 1 |
Drug: Testosterone Replacement Therapy Patch 5mg daily
Testosterone Replacement Therapy Patch 5mg daily
Other Name: Androderm Testosterone Transdermal System
|
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 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 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 (> 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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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 (Total > 4 ng/ml)]
- 10 subjects with eugonadism (Total > 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
Contacts and Locations| United States, New Jersey | |
| Kessler Institute for Rehabilitation | |
| West Orange, New Jersey, United States, 07052 | |
| United States, New York | |
| VA Medical Center, Bronx | |
| Bronx, New York, United States, 10468 | |
| Principal Investigator: | William Bauman, MD | VA Medical Center, Bronx |
More Information
Additional Information:
Publications:
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00266864 History of Changes |
| Other Study ID Numbers: | B2648-C |
| Study First Received: | December 15, 2005 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Eugonadism Hypogonadism Spinal Cord Injury Testes Testosterone |
Additional relevant MeSH terms:
|
Hypogonadism Spinal Cord Injuries Gonadal Disorders Endocrine System Diseases Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries Testosterone Testosterone enanthate Testosterone undecanoate |
Testosterone 17 beta-cypionate Methyltestosterone Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anabolic Agents |
ClinicalTrials.gov processed this record on May 19, 2013