Provocative Testing Using LHRH and hCG of the Pituitary-Gonadal Axis in Persons With Spinal Cord Injury.
Completed · Not applicable
Conditions studied: Hypogonadism, Spinal Cord Injury
In brief
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 from the hypothalamic pituitary system (part of the brain that plays a role in testosterone release) or from the male testes. Studies to date are inconclusive. This study, will examine if persons with SCI has a normal hormonal regulation of the male hormone testosterone in comparison to persons who are able-bodied. This will help understand the physical and metabolic changes that occur in persons with SCI.
Key facts
- Study ID
- NCT00223860
- Run by
- US Department of Veterans Affairs
- People needed
- 100
- Starts
- 2001-07-01
- Expected to finish
- 2007-12-01
- Last updated by the study team
- 2008-03-11
Who can join
Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- VA Medical Center, Bronx — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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