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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Collaborator: |
Kessler Institute for Rehabilitation |
| Information provided by (Responsible Party): | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00266864 |
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 II Phase III |
| 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 |
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2003 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1 |
Drug: Testosterone Replacement Therapy Patch 5mg daily
Testosterone Replacement Therapy Patch 5mg daily
Other Name: Androderm Testosterone Transdermal System
|
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:
Exclusion Criteria:
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
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00266864 History of Changes |
| Other Study ID Numbers: | B2648C |
| Study First Received: | December 15, 2005 |
| Last Updated: | October 25, 2011 |
| Health Authority: | United States: Federal Government |
|
Eugonadism Hypogonadism Spinal Cord Injury Testes Testosterone |
|
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 |