Low levels of testosterone, the major male hormone, may contribute to a number of problems in older men, such as decreased physical and sexual function, impaired cognition, low vitality, cardiovascular disease and anemia. Researchers at Yale School of Medicine will test whether these conditions can be improved with testosterone therapy.
The Testosterone Trial (T-Trial) is a large-scale clinical study that is being conducted at Yale and 11 other sites across the nation. Funded primarily by the National Institute on Aging (NIA), part of the National Institutes of Health, the T-Trial is coordinated by the University of Pennsylvania and will involve 800 men age 65 and older with low testosterone levels.
“As men age, testosterone levels decline, which may lead to many conditions that are often attributed to age alone,” said Thomas M. Gill, M.D., professor of medicine at Yale and a specialist in the health of older adults. “The T-Trial is designed to provide definitive evidence on whether testosterone can reverse these conditions. If we find that it is a beneficial therapy, this would provide men and their doctors with the information they need to make treatment decisions. One of our main goals is to help older men with low testosterone remain healthy and independent longer than would have been possible otherwise.”
The T-Trial will include separate studies focusing on five conditions: decreased physical function, low vitality, reduced sexual function, impaired cognition and anemia. Men 65 years or older with low serum testosterone and at least one of these conditions will be randomly assigned to a treatment groups or a control group. Men in the treatment group will be given a testosterone gel that is applied to the torso, abdomen, or upper arm, while men in the control group 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, sexual function and cardiovascular disease.
Men in and around Connecticut who are interested in participating in the trial should call the Yale study center at 203-737-5672 or toll free 1-877-523-5672 or contact Ttrial@yale.edu. Men living within a 50-mile radius of Yale School of Medicine and New Haven are especially encouraged to participate. More information about the study and criteria for participation are available at www.ttrial.org
Additional funding for the trial is 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.
