Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112151
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2005-05-27
Brief Title:
TEAM Testosterone Supplementation and Exercise in Elderly Men
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Testosterone Supplementation and Exercise in Elderly Men
Status:
COMPLETED
Status Verified Date:
2020-08
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:
The purpose of this study is to evaluate the effects of testosterone supplementation AndroGel on body composition strength endurance cognition and function in older men
Detailed Description:
Studies suggest that testosterone T replacement in healthy elderly men has beneficial effects on body composition muscle bone memory and behavior but the risks of chronic treatment especially on the prostate heart and sleep quality are not entirely clear Therefore it is most desirable to supplement into the lowest effective range in elderly men However the effects of lower than usual replacement T doses have not been well studied Furthermore the possible important interaction of exercise to enhance the positive effects of T supplementation yet mitigate the possible side effects has not been studied in older men
This one-year study will enroll 150 men with low-normal to slightly below normal serum total T levels Participants will be randomized into one of 6 treatment groups to receive T supplementation AndroGel of 25mgday 50 mgday or a placebo crossed with progressive resistance training PRT exercise 3 times a week versus none At the end of the study participants in the exercise-control group will be offered PRT
Please see link below for updated version of full protocol
This one-year study will enroll 150 men with low-normal to slightly below normal serum total T levels Participants will be randomized into one of 6 treatment groups to receive T supplementation AndroGel of 25mgday 50 mgday or a placebo crossed with progressive resistance training PRT exercise 3 times a week versus none At the end of the study participants in the exercise-control group will be offered PRT
Please see link below for updated version of full protocol
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG019339 | NIH | None | httpsreporternihgovquickSearchR01AG019339 |