Testosterone Replacement in Older Men and Atherosclerosis Progression
Recruitment status was Active, not recruiting
As men grow older, their testosterone levels decrease with age. One-third of men, 70 years of age or older, have low testosterone levels. It is known that short-term testosterone replacement is safe, and can increase muscle strength and physical function, but the risks of long-term testosterone replacement in older men with low testosterone levels are incompletely understood.
Atherosclerosis is characterized by thickening of the artery walls, and the narrowing of the blood vessels as cholesterol is deposited in the lining of the arteries. It is the major cause of cardiovascular disease including ischemic heart disease (heart attacks) and stroke. Although, historically, there has been a widespread perception that higher levels of testosterone might increase the risk of atherosclerosis, the evidence from research does not support this. In observational studies, higher testosterone levels have been correlated with more favorable cardiovascular risk factors, and supplementation with testosterone to bring older men into the normal range for healthy younger men appears to improve several cardiovascular risk factors, and may slow the progression of atherosclerosis.
The primary purpose of this study is to look at the effects of testosterone replacement on the progression of atherosclerosis in older men. This study is also being done to find out whether replacement with testosterone in older men with low testosterone levels improves their health-related quality of life.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Effects of Testosterone Replacement on Atherosclerosis Progression in Older Men With Low Testosterone Levels|
- Atherosclerosis progression as assessed by Cardiac CT and Carotid IMT [ Time Frame: Three years ] [ Designated as safety issue: No ]
- Changes in Lipid Profiles [ Time Frame: Three years ] [ Designated as safety issue: No ]
- Changes in Biomarkers of Inflammation [ Time Frame: Three years ] [ Designated as safety issue: No ]
- Changes in Blood Pressure [ Time Frame: Three years ] [ Designated as safety issue: No ]
- Changes in Cognitive Function [ Time Frame: Three years ] [ Designated as safety issue: No ]
- Changes in Muscle Strength [ Time Frame: Three years ] [ Designated as safety issue: No ]
- Changes in Physical Function [ Time Frame: Three years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2003|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Drug: Testosterone Gel (Androgel)
The subjects will receive either 7.5 g testosterone gel to achieve a nominal delivery of 75 mg testosterone daily or placebo gel. Dose adjustments will be made by an unblinded observer.
This will be implemented as follows: Serum testosterone level measured on treatment day 15 will measured in a sample sent separately to the laboratory such that the result will be reported directly to unblinded physician, who will then communicate the decision about dose adjustment (or not) directly to the research pharmacist through e-mail.
|United States, Arizona|
|Kronos Longevity Research Institute|
|Phoenix, Arizona, United States, 85016|
|United States, California|
|Charles R. Drew University of Medicine and Science|
|Los Angeles, California, United States, 90059|
|United States, Massachusetts|
|Boston University / Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Shalender Bhasin, MD||Boston University / Boston Medical Center, Boston, MA|