November 2, 2009
Philadelphia, Pa. -- Penn Medicine will lead a new national $45 million clinical trial to test whether testosterone therapy can favorably affect certain conditions affecting older men. Low serum testosterone may contribute to a number of problems affecting older men, including decreased ability to walk, loss of muscle mass and strength, decreased vitality, decreased sexual function, impaired cognition, cardiovascular disease and anemia. While testosterone normally decreases with age, in some men, low levels of testosterone may contribute to these debilitating conditions.
The Testosterone Trial will include five separate studies. At each of the 12 sites, 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.
The University of Pennsylvania School of Medicine is the lead institution for the trial and will serve as coordinating center. Peter J. Snyder, M.D., Professor of Medicine in the Division of Endocrinology, Diabetes and Metabolism at Penn, is the principal investigator and will oversee trial activities. "This is an unprecedented opportunity for older men to learn more about themselves and at the same time help find out if testosterone will improve some of the afflictions of old age," said Dr. Snyder.
A 2004 report by the Institute of Medicine, "Testosterone and Aging: Clinical Research Directions," noted several important unanswered questions about the effects of testosterone therapy. Researchers aim to answer these questions by testing the effectiveness of testosterone therapy in older men with low testosterone levels and one of the following conditions: impaired walking, low vitality, sexual or cognitive dysfunction. A key consideration is the use of testosterone as a therapy for certain conditions, rather than as a preventive measure.
"This study is important because testosterone products have been marketed for many years as treatments for a variety of conditions," said Evan C. Hadley, M.D., director of NIA's Division of Geriatrics and Clinical Gerontology, which is the primary funder of the trial. "We hope this trial will establish whether testosterone therapy results in clear benefits for older men."
The NIA is the primary source of support for this trial. Additional funding is being provided by the National Heart, Lung, and Blood Institute (NHLBI); the National Institute on Neurological Disorders and Stroke (NINDS); the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and Solvay Pharmaceuticals, which is also supplying the study drug.