Anabolic Therapies: New Hope for Treating Secondary Disabilities of SCI - NCT00266864-10468 (Clinical Trial 134937)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy134937.aspx
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| City: |
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Bronx |
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State:
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NY |
| Zip Code: |
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10468 |
| Conditions: |
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Hypogonadism - Spinal Cord Injury |
| Purpose: |
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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
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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VA Medical Center, Bronx
Bronx, NY 10468
United States
Primary Contact:
Shevana Swaby, BS
Email: shevana.swaby@va.gov
Phone: (718) 584-9000 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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