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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypogonadism; Spinal Cord Injury
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 1	Drug: Human chorionic gonadotropin (hCG); Drug: Luteinizing hormone releasing hormone (LHRH)

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• 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

Study record dates

Study Major Dates

• Study Start: July 1, 2001
• Primary Completion (ACTUAL): December 1, 2007
• Study Completion (ACTUAL): December 1, 2007

Study Registration Dates

• First Submitted: September 14, 2005
• First Submitted That Met QC Criteria: September 14, 2005
• First Posted (ESTIMATE): September 22, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): March 11, 2008
• Last Update Submitted That Met QC Criteria: March 5, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: Spinal Cord Injury; Pituitary; Testosterone; Hypothalamus; Hypogonadal; Testes
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Gonadal Disorders; Trauma, Nervous System; Spinal Cord Diseases; Hypothalamic Diseases; Wounds and Injuries; Pituitary Diseases; Hypogonadism; Spinal Cord Injuries; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Reproductive Control Agents; Hormones; Chorionic Gonadotropin; Prolactin Release-Inhibiting Factors
• Other Study ID Numbers: B2648