Status:
COMPLETED
Testosterone Replacement Therapy in Chronic Spinal Cord Injury
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Kessler Institute for Rehabilitation
Conditions:
Spinal Cord Injury
Hypogonadism
Eligibility:
MALE
18-49 years
Phase:
PHASE2
PHASE3
Brief Summary
It has long been recognized that co-morbidity associated with multiple metabolic syndrome, such as adverse body composition, insulin resistance and autonomic nervous system impairment, may lead to sig...
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 ≤ 11.3 nmol/l will start testosterone rep...
Eligibility Criteria
Inclusion
- Males 18-49 years of age
- Chronic spinal cord injury
- Normal prostate specific antigen levels and digital rectal exam
- No known cardiovascular disease
- Subjects with total testosterone \> 4 ng/ml
- Subjects with total testosterone \> 4 ng/ml
Exclusion
- 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
- Prostate specific antigen above normal
- Abnormal digital rectal exam at baseline suggestive of malignancy
- Current alcohol or drug abuse
- Significant psychological disorders
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00266864
Start Date
August 1 2003
End Date
December 1 2012
Last Update
November 1 2017
Active Locations (2)
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1
Kessler Institute for Rehabilitation
West Orange, New Jersey, United States, 07052
2
James J. Peters VA Medical Center
The Bronx, New York, United States, 10468