Media Relations
News Releases
For Release Upon Receipt - November 9, 2009
Contact:
Allison Rubin, 617-638-8491, afrubin@bu.edu
BOSTON MEDICAL CENTER WILL STUDY TESTOSTERONE IN OLDER MEN
Participants Sought for National Study
(Boston) - Boston Medical Center (BMC) today announced that it 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. Known as The Testosterone Trial, the study will test whether these conditions can be improved with testosterone therapy. BMC is the only site in Boston to participate in this trial.
“This may be the most important study in men’s health in the past 80 years. This study will provide a clear understanding of both the benefits and risks associated with testosterone therapy,” said Shalender Bhasin, MD, BMC’s principal investigator and chief of the department of endocrinology at BMC. “We are conducting this study because low testosterone levels can adversely affect the health of older men in several critical areas. 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 otherwise,” he added.
Funded primarily by the National Institute on Aging 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; BMC is seeking to recruit about 70 men from the area in 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—decreased physical function, low vitality, impaired cognition, anemia, 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 Boston-area who are interested in participating in the trial should call the Boston Medical Center study center at 617-414-2968 or contact www.androtrials.org. Men living within a 50-mile radius of BMC are especially encouraged to participate. 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.
Boston Medical Center is a private, not-for-profit, 626-licensed bed, academic medical center affiliated with Boston University School of Medicine. Committed to providing high-quality health care to all, the hospital offers a full spectrum of pediatric and adult care services including primary and family medicine and advanced specialty care with an emphasis on community-based care. Boston Medical Center offers specialized care for complex health problems and is a leading research institution. Boston Medical Center and Boston University School of Medicine are partners in the Boston HealthNet—15 community health centers focused on providing exceptional health care to residents of Boston. For more information, please visit www.bmc.org.
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