November 17, 2003, Chevy Chase, MD - The Endocrine Society, the largest and most active professional organization of endocrinologists in the world, today announced its support for the Institute of Medicine (IOM) report titled Testosterone and Aging: Clinical Research Directions. The report was drafted by a panel of experts formed in November 2002 to review and assess the current state of knowledge related to the health risks and benefits of testosterone therapy in aging men. It sets forth recommendations for clinical trials of testosterone therapy, including specific parameters that should be considered in study design and conduct.

The Endocrine Society agrees with the panel's key conclusions and believes that it is critical that the medical community determine whether testosterone treatment results in clear benefits for aging men before long-term trials are conducted. Additionally, the Society agrees that testosterone therapy should be evaluated initially as a therapeutic, not as a preventive measure for aging men. Finally, it is reasonable that clear short-term benefits of testosterone therapy be established in testosterone deficient men over the age of 65 before committing the time, energy and cost of a properly powered study of the long-term benefits and risks of testosterone therapy in this age group.

The Endocrine Society supports the IOM panel in their efforts to help the public and the medical community better understand the existing body of knowledge on testosterone therapy and develop directions for future clinical studies on testosterone therapy for older men.

The Endocrine Society supports the IOM recommendations for future clinical trials on testosterone, which include:

• Conduct clinical trials on older men with low testosterone levels.
• Begin with short-term, randomized double-blind, placebo-controlled efficacy trials to determine the benefits of testosterone therapy in older men. Furthermo
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Contact: Marisa Lavine
mlavine@endo-society.org
301-941-0255
The Endocrine Society & The Hormone Foundation
17-Nov-2003


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