Status:
COMPLETED
Provocative Testing Using LHRH and hCG of the Pituitary-Gonadal Axis in Persons With Spinal Cord Injury.
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Hypogonadism
Spinal Cord Injury
Eligibility:
MALE
18-65 years
Phase:
NA
Brief Summary
There is evidence that has shown that serum testosterone levels are low in persons with chronic spinal cord injury (SCI). The question arises as to whether the defect in testosterone production is fro...
Detailed Description
Absolute or relative testosterone deficiency is associated with loss of lean body tissue and gain of fat, with associated adverse carbohydrate, lipid, and energy expenditure changes that increase the ...
Eligibility Criteria
Inclusion
- SCI with serum total testosterone 3.0 ng/ml (SCI eugonadal, n=25),
- SCI with serum total testosterone \<3.0 ng/ml (SCI hypogonadal, n=25),
- able-bodied controls with serum total testosterone 3.0 ng/ml (control eugonadal, n=25), and
- able-bodied controls with serum total testosterone \<3.0 ng/ml (control hypogonadal, n=25). All SCI and control subjects will be screened for serum gonadotropin levels within the normal range as an inclusion criterion.
Exclusion
- acute illness,
- active thyroid disease,
- pyschotropic medications,
- anti-hypertensive medications (centrally acting, i.e., guanethidine, reserpine, methyldopa, b-adrenergic blockers, clonidine, etc.),
- H2-blockers,
- digoxin,
- alcoholism,
- anti-convulsant medications (dilantin or barbiturates)
- diuretics (thiazides or spironolactone),
- chemotherapeutic agents,
- antibiotics,
- opiates,
- hormones (other than replacement doses),
- history of pituitary or testicular surgery. Abstinence from alcoholic beverages will be required for 48 hours prior to study.
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00223860
Start Date
July 1 2001
End Date
December 1 2007
Last Update
March 11 2008
Active Locations (1)
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1
VA Medical Center, Bronx
The Bronx, New York, United States, 10468