Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT00223860
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.
Study:
NCT00223860
Study Brief:
Protocol Section:
NCT00223860