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

Primary Purpose

Hypogonadism, Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Human chorionic gonadotropin (hCG)
Luteinizing hormone releasing hormone (LHRH)
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypogonadism focused on measuring Hypogonadal, Hypothalamus, Pituitary, Spinal Cord Injury, Testes, Testosterone

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: 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 Criteria: 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.

Sites / Locations

  • VA Medical Center, Bronx

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 14, 2005
Last Updated
March 5, 2008
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00223860
Brief Title
Provocative Testing Using LHRH and hCG of the Pituitary-Gonadal Axis in Persons With Spinal Cord Injury.
Official Title
Provocative Testing Using LHRH and hCG of the Pituitary-Gonadal Axis in Persons With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism, Spinal Cord Injury
Keywords
Hypogonadal, Hypothalamus, Pituitary, Spinal Cord Injury, Testes, Testosterone

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Human chorionic gonadotropin (hCG)
Intervention Type
Drug
Intervention Name(s)
Luteinizing hormone releasing hormone (LHRH)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Bauman, MD
Organizational Affiliation
VA Medical Center, Bronx
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Bronx
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7557841
Citation
Tsitouras PD, Zhong YG, Spungen AM, Bauman WA. Serum testosterone and growth hormone/insulin-like growth factor-I in adults with spinal cord injury. Horm Metab Res. 1995 Jun;27(6):287-92. doi: 10.1055/s-2007-979961.
Results Reference
result
PubMed Identifier
8487676
Citation
Huang TS, Wang YH, Chiang HS, Lien YN. Pituitary-testicular and pituitary-thyroid axes in spinal cord-injured males. Metabolism. 1993 Apr;42(4):516-21. doi: 10.1016/0026-0495(93)90112-2.
Results Reference
result
Links:
URL
http://www.unitedspinal.org
Description
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