Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266864
Status:
COMPLETED
Last Update Posted:
2017-11-01
First Post:
2005-12-15
Brief Title:
Testosterone Replacement Therapy in Chronic Spinal Cord Injury
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Testosterone Replacement Therapy in Chronic Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2017-09
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:
It has long been recognized that co-morbidity associated with multiple metabolic syndrome such as adverse body composition insulin resistance and autonomic nervous system impairment may lead to significant increase in cardiovascular morbidity and mortality It is unclear whether the co-morbidity evident in this population are due directly to their immobility or are the result of unfavorable changes in their underlying hormonal milieu The purpose of this study is to determine the effect of testosterone replacement therapy in hypogonadal males on
body composition ie lean tissue and fat mass glucose tolerance resting energy expenditure autonomic-cardiovascular integrity muscular strength psychological assessment
body composition ie lean tissue and fat mass glucose tolerance resting energy expenditure autonomic-cardiovascular integrity muscular strength psychological assessment
Detailed Description:
This study is 24 months in duration Men who have consented to pre-screening serum testosterone draw and are found to have total testosterone levels averaging 113 nmoll will start testosterone replacement therapy after a 6-month baseline period Once treatment begins subjects will place a testosterone replacement patch 5 or 10 mgday on various sites of the body daily Subjects will visit the lab after 26 12 and 18 months of therapy for testing however they will stop taking the patch at the 12 month visit If needed a steroid cream will be provided to the subjects should any skin irritations occur If the patch causes persistent skin irritations despite use of the steroid cream then a testosterone gel may be used Detailed instructions and precautions using the gel are outlined in the consent form and will be reviewed with the subject
Those men who have consented to pre-screening serum testosterone and are found to have normal levels of total testosterone testosterone total 114 nmoll are eligible to participate as a control subject for the full 24-month period of the study These subjects visit the lab at baseline BL 12 and 24 months for the same testing as those in the treatment group
Those men who have consented to pre-screening serum testosterone and are found to have normal levels of total testosterone testosterone total 114 nmoll are eligible to participate as a control subject for the full 24-month period of the study These subjects visit the lab at baseline BL 12 and 24 months for the same testing as those in the treatment group
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