Participants Sought for National Trial
UC San Diego School of Medicine is seeking volunteers for a national study to test the effects of testosterone as a treatment for several conditions affecting the health of older men. Low serum testosterone may contribute to a number of problems experienced by older men, including decreased ability to walk, loss of muscle mass and strength, decreased vitality, decreased sexual function, impaired cognition, cardiovascular disease and anemia. The Testosterone Trial will test whether these conditions can be improved with testosterone therapy.
“Low testosterone levels can adversely affect the health of older men in several critical areas,” said Elizabeth Barrett-Connor, MD, Distinguished Professor and Chief, Division of Epidemiology, Department of Family and Preventive Medicine. “If this treatment proves effective, we may be able to help older men with low testosterone remain healthy and independent longer than would have been possible.”
Funded primarily by the National Institute on Aging (NIA) and coordinated by the University of Pennsylvania School of Medicine, the Testosterone Trial will be conducted at 12 sites across the country. Overall, the study will involve 800 men; UC San Diego School of Medicine is seeking to recruit about 70 men from the area for the trial.
- The Testosterone Trial will include five separate studies: Men 65 and older with low serum testosterone and at least one of the following conditions – anemia, decreased physical function, low vitality, impaired cognition or reduced sexual function – will be randomly assigned to participate in a treatment group or a control group
- Treatment groups will be given a testosterone gel that is applied to the torso, abdomen or upper arms
- Control groups will receive a placebo gel
- Serum testosterone will be measured monthly for the first three months and quarterly thereafter, up to one year
- Participants will be tested on a wide range of measures to evaluate physical function, vitality, cognition, cardiovascular disease and sexual function.
“Testosterone products have been marketed for many years as treatments for a variety of conditions,” said Evan C. Hadley, MD, director of NIA’s Division of Geriatrics and Clinical Gerontology. “We hope this trial will establish whether testosterone therapy results in clear benefits for older men.”
Men in the San Diego County area who are interested in participating in the trial should call UC San Diego’s study center at (877) 219-6610 or visit: www.ttrial.org
More information about the study and criteria for participation is available at: http://www.clinicaltrials.gov/ct2/show/NCT00799617?term=testosterone+aging&rank=40.
The NIA is the primary source of support for this trial. Additional funding is being provided by the National Heart, Lung, and Blood Institute, the National Institute on Neurological Disorders and Stroke, the Eunice Kennedy Shriver National Institute of Child Health and Human Development and Solvay Pharmaceuticals, which is also supplying the study drug.
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