For information on enrolling in this study, call 205-934-2294
BIRMINGHAM, Ala. - The University of Alabama at Birmingham (UAB) Division of Preventive 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.
"We are conducting this study because low testosterone levels can adversely affect the health of older men in several critical areas," said Cora E. Lewis, M.D., principal investigator of the study at UAB. "If this treatment proves effective, we may be able to help older men with low testosterone remain healthy and independent longer than otherwise would have been possible.
"Because we were a site for the major study of female hormones in postmenopausal women, the Women's Health Initiative, we are very anxious to participate in this study to answer critically important questions on the potential benefits of testosterone in men," Lewis.
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; UAB is seeking to recruit about 70 men 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.
"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. "We hope this trial will establish whether testosterone therapy results in clear benefits for older men."
Men in the Birmingham area who are interested in participating in the trial should call the UAB study center at 205-934-2294. Men living within a 50-mile radius of Birmingham are especially encouraged to participate. More information about the study and criteria for participation is available at www.clinicaltrials.gov/ct2/show/NCT00799617.
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 also is supplying the study drug.
About the UAB Division of Preventive Medicine
The UAB Division of Preventive Medicine is dedicated to medicine and the health of the public through research, teaching and dissemination and translation of knowledge for improved health outcomes. From its inception in 1967, the division has played a key role in the many groundbreaking trials contributing to the knowledge of medical and health systems, behavioral aspects of disease, epidemiology, prevention, control and disease outcomes. Special concern for health disparities and a desire to promote women's health guide many division activities. A research-oriented division, it also has active programs for the training of post-doctoral fellows and clinical scholars.