Provocative Testing Using LHRH and hCG of the Pituitary-Gonadal Axis in Persons With Spinal Cord Injury.

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Male

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Chorionic Gonadotropin; Hormones; Prolactin Release-Inhibiting Factors

Criteria

Inclusion Criteria:

1. SCI with serum total testosterone 3.0 ng/ml (SCI eugonadal, n=25),

2. SCI with serum total testosterone <3.0 ng/ml (SCI hypogonadal, n=25),

3. able-bodied controls with serum total testosterone 3.0 ng/ml (control eugonadal, n=25), and

4. 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 Criteria:

1. acute illness,

2. active thyroid disease,

3. pyschotropic medications,

4. anti-hypertensive medications (centrally acting, i.e., guanethidine, reserpine, methyldopa, b-adrenergic blockers, clonidine, etc.),

5. H2-blockers,

6. digoxin,

7. alcoholism,

8. anti-convulsant medications (dilantin or barbiturates)

9. diuretics (thiazides or spironolactone),

10. chemotherapeutic agents,

11. antibiotics,

12. opiates,

13. hormones (other than replacement doses),

14. history of pituitary or testicular surgery. Abstinence from alcoholic beverages will be required for 48 hours prior to study.