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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Collaborator: |
Kessler Institute for Rehabilitation |
| Information provided by: | 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: | Treatment, Non-Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study |
| 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
|
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| Contact: Shevana Swaby, BS | (718) 584-9000 ext 3123 | shevana.swaby@va.gov |
| Contact: Chris Cirnigliaro, MS | (973) 731-3900 ext 2755 | ccirnig@yahoo.com |
| United States, New Jersey | |
| Kessler Instsitute for Rehabilitation | Recruiting |
| West Orange, New Jersey, United States, 07052 | |
| Contact: Chris Cirnigliaro, MS 973-731-3600 ext 2755 christopher.cirnigliaro@va.gov | |
| United States, New York | |
| VA Medical Center, Bronx | Active, not recruiting |
| Bronx, New York, United States, 10468 | |
| Principal Investigator: | William Bauman, MD | VA Medical Center, Bronx |
More Information
| Responsible Party: | Department of Veterans Affairs ( Bauman, William - Principal Investigator ) |
| Study ID Numbers: | B2648C |
| Study First Received: | December 15, 2005 |
| Last Updated: | December 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00266864 History of Changes |
| Health Authority: | United States: Federal Government |
|
Eugonadism Hypogonadism Spinal Cord Injury Testes Testosterone |
|
Antineoplastic Agents, Hormonal Spinal Cord Diseases Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Nervous System Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Wounds and Injuries Endocrine System Diseases Central Nervous System Diseases Disorders of Environmental Origin |
Trauma, Nervous System Methyltestosterone Hormones Pharmacologic Actions Testosterone 17 beta-cypionate Spinal Cord Injuries Anabolic Agents Testosterone Hypogonadism Therapeutic Uses Androgens |