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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00223860
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : March 11, 2008
Sponsor:
Information provided by:
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Hypogonadism Spinal Cord Injury Drug: Human chorionic gonadotropin (hCG) Drug: Luteinizing hormone releasing hormone (LHRH) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Provocative Testing Using LHRH and hCG of the Pituitary-Gonadal Axis in Persons With Spinal Cord Injury
Study Start Date : July 2001
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Gonadorelin

Arm Intervention/treatment
1 Drug: Human chorionic gonadotropin (hCG)
Drug: Luteinizing hormone releasing hormone (LHRH)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223860


Locations
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United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
US Department of Veterans Affairs
Investigators
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Principal Investigator: William Bauman, MD VA Medical Center, Bronx
Additional Information:
Publications of Results:
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Responsible Party: Bauman, William - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00223860    
Other Study ID Numbers: B2648
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: March 11, 2008
Last Verified: March 2008
Keywords provided by VA Office of Research and Development:
Hypogonadal
Hypothalamus
Pituitary
Spinal Cord Injury
Testes
Testosterone
Additional relevant MeSH terms:
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Spinal Cord Injuries
Pituitary Diseases
Hypogonadism
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Hypothalamic Diseases
Brain Diseases
Endocrine System Diseases
Gonadal Disorders
Chorionic Gonadotropin
Hormones
Prolactin Release-Inhibiting Factors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents