Provocative Testing Using LHRH and hCG of the Pituitary-Gonadal Axis in Persons With Spinal Cord Injury.
Information source: Department of Veterans Affairs
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypogonadism; Spinal Cord Injury
Intervention: Human chorionic gonadotropin (hCG) (Drug); Luteinizing hormone releasing hormone (LHRH) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s): William Bauman, MD, Principal Investigator, Affiliation: VA Medical Center, Bronx
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.
Clinical Details
Official title: Provocative Testing Using LHRH and hCG of the Pituitary-Gonadal Axis in Persons With Spinal Cord Injury
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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 risk of cardiovascular disease. Impotence and infertility are common in
patients with SCI. Of the many possible explanations of poor semen quality, one possible
etiology is dysfunction of the hypothalamic-pituitary-testicular axis. Early reports have
been inconclusive with regard to testicular function. These apparent discrepancies could, at
least in part, be attributed to varying factors in population selection, including health
and nutrition parameters, medication effects, and level and duration of injury, or to
differences in methodology. Recently, two large population studies found a sizeable
proportion of persons with SCI having testosterone deficiency. Huang et al. (1993) found
significantly elevated luteinizing hormone (LH) responses to LH releasing hormone (LHRH) in
subjects with SCI compared to controls. Of those studied with LHRH stimulation, 16/30
subjects with SCI had exaggerated LH responses and 6/30 had elevated follicular stimulation
hormone (FSH) responses. Bulat et al., (1995) have shown that persons with tetraplegia tend
to have increased gonadotropin release to standard provocative stimulation compared with
able-bodied controls or those with paraplegia. In a preliminary report, testicular
stimulation with standard doses of hCG for 2 days was similar in 10 subjects with SCI and 8
able-bodied controls.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Male.
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.
Locations and Contacts
VA Medical Center, Bronx, Bronx, New York 10468, United States
Additional Information
Click here for more information about this study: Provocative Testing Using LHRH and hCG of the Pituitary-Gonadal Axis in Persons With Spinal Cord Injury
Starting date: July 2001
Last updated: March 5, 2008
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