Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223860
Status:
COMPLETED
Last Update Posted:
2008-03-11
First Post:
2005-09-14
Brief Title:
Provocative Testing Using LHRH and hCG of the Pituitary-Gonadal Axis in Persons With Spinal Cord Injury
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Provocative Testing Using LHRH and hCG of the Pituitary-Gonadal Axis in Persons With Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1630 subjects with SCI had exaggerated LH responses and 630 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None