November 2, 2009

Major U.S. research launched to study effects of low testosterone in older men

News Summary

• The University of Minnesota has been selected to lead a clinical trial site for national research which is studying whether a testosterone therapy can improve certain health conditions affecting older men. Low serum testosterone levels may be tied 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, and anemia. This multi-site study will test whether any of these conditions can be improved with a testosterone gel therapy.
• 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 the University of Minnesota and 11 other sites across the country.  Overall, the study will include 800 men, 70 of which will be recruited by the University of Minnesota.
• The Testosterone Trial will enroll men age 65 and older who have low serum testosterone levels and at least one other symptom including decreased physical function, low vitality, or reduced sexual function. Participants will be given a testosterone or placebo gel and will then be tested on a wide range of measures to evaluate physical function, vitality, cognition, sexual function, and anemia.
• 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.

Quotes

• "We are conducting this study because low testosterone levels may adversely affect the health of older men in several different ways. If this treatment proves effective, we may be able to help older men with low testosterone remain healthy and stay independent longer than would have been possible otherwise." -Kristine Ensrud, M.D.
  
• "This study is important because testosterone products have been marketed for many years as treatments for a variety of conditions. We hope this trial will establish whether testosterone therapy results in clear benefits for older men." -Evan Hadley, M.D.

About the Academic Health Center

The Academic Health Center is home to the University of Minnesota's six health professional schools and colleges as well as several health-related centers and institutes. Founded in 1851, the University is one of the oldest and largest land grant institutions in the country. The AHC prepares the new health professionals who improve the health of communities, discover and deliver new treatments and cures, and strengthen the health economy. For more information, visit www.ahc.umn.edu.

Full Text

MINNEAPOLIS / ST. PAUL (November 2, 2009) The University of Minnesota has been selected to lead a clinical trial site for national research which is studying whether a testosterone therapy can improve certain health conditions affecting older men. Low serum testosterone levels may be tied 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, and anemia. This multi-site study will test whether any of these conditions can be improved with a testosterone gel therapy.

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 the University of Minnesota and 11 other sites across the country.  Overall, the study will include 800 men, 70 of which will be recruited by the University of Minnesota.

 "We are conducting this study because low testosterone levels may adversely affect the health of older men in several different ways," said Kristine Ensrud, M.D., principal investigator at the University of Minnesota. "If this treatment proves effective, we may be able to help older men with low testosterone remain healthy and stay independent longer than would have been possible otherwise."

The Testosterone Trial will enroll men age 65 and older who have low serum testosterone levels and at least one other symptom including decreased physical function, low vitality, or reduced sexual function. Participants will be given a testosterone or placebo gel and will then be tested on a wide range of measures to evaluate physical function, vitality, cognition, sexual function, and anemia.

"This study is important because testosterone products have been marketed for many years as treatments for a variety of conditions," said Evan 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 Twin Cities metropolitan area who are interested in participating in the trial should call Kristi Jacobson at the University of Minnesota clinical center at 612-625-4449. More information about the study and criteria for participation is available online.
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.