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

This study has been completed.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00223860
  Purpose

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 Intervention
Hypogonadism
Spinal Cord Injury
Drug: Human chorionic gonadotropin (hCG)
Drug: Luteinizing hormone releasing hormone (LHRH)

MedlinePlus related topics:   Spinal Cord Injuries    Testicular Disorders   

ChemIDplus related topics:   Testosterone    Methyltestosterone    Oxymesterone    Testosterone enanthate    Testosterone Propionate    Testosterone undecanoate    Chorionic gonadotropin    Choriogonadotropin Alfa    Gonadorelin    Gonadorelin hydrochloride    LH-RH   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacodynamics Study
Official Title:   Provocative Testing Using LHRH and hCG of the Pituitary-Gonadal Axis in Persons With Spinal Cord Injury

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment:   100
Study Start Date:   July 2001
Study Completion Date:   December 2007
Primary Completion Date:   December 2007 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1 Drug: Human chorionic gonadotropin (hCG) Drug: Luteinizing hormone releasing hormone (LHRH)

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
Ages Eligible for Study:   18 Years to 65 Years
Genders 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223860

Locations
United States, New York
VA Medical Center, Bronx    
      Bronx, New York, United States, 10468

Sponsors and Collaborators

Investigators
Principal Investigator:     William Bauman, MD     VA Medical Center, Bronx    
  More 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  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Responsible Party:   Department of Veterans Affairs ( Bauman, William - Principal Investigator )
Study ID Numbers:   B2648
First Received:   September 14, 2005
Last Updated:   March 5, 2008
ClinicalTrials.gov Identifier:   NCT00223860
Health Authority:   United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Hypogonadal  
Hypothalamus  
Pituitary  
Spinal Cord Injury
Testes
Testosterone

Study placed in the following topic categories:
Spinal Cord Diseases
Gonadal Disorders
Testicular Diseases
Wounds and Injuries
Endocrine System Diseases
Central Nervous System Diseases
Disorders of Environmental Origin
Trauma, Nervous System
Methyltestosterone
Chorionic Gonadotropin
Testosterone 17 beta-cypionate
Spinal Cord Injuries
Testosterone
Hypogonadism
Endocrinopathy

Additional relevant MeSH terms:
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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