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Scientific task force to examine usefulness of testosterone replacement therapy in older men

A multi-disciplinary task force, led by the Institute of Medicine (IOM) and supported by the National Institute on Aging (NIA), will evaluate the pros and cons of conducting clinical trials of testosterone replacement therapy in older men. The year-long task force, announced today by the NIA and IOM, will make recommendations regarding the design, safety, and ethics of clinical trials of this intervention, including whether such studies are even warranted.

The task force was conceived, in part, because of growing concerns about an increase in the number of older men apparently using testosterone replacement therapy (TRT) in the absence of adequate scientific information about its risks and benefits, said NIA Director Richard Hodes, M.D.

"In forming this partnership with the IOM, the NIA is moving forward in two directions: One, to determine the extent and nature of the risks and benefits, and two, to explore the scientific and ethical questions that must be asked before any clinical trials of this intervention can be safely and prudently conducted," Dr. Hodes said.

The task force, which will consist of prominent scientists specializing in epidemiology, endocrinology, urology, oncology and other relevant fields, will review and assess the current state of knowledge concerning testosterone replacement therapy (TRT) and prepare an evidence-based report outlining the benefits and adverse effects of this intervention, the potential public health impact of TRT in the United States, and the ethical issues involved in the conduct of a clinical trial of TRT. The committee will conduct four meetings and one workshop in the next 12 months.

"Although some older men who have tried these supplements report feeling 'more energetic' or 'younger,' testosterone supplementation remains a scientifically unproven method for preventing or relieving any physical and psychological changes that men with normal testosterone levels may experience, as they get older. Until
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Contact: Doug Dollemore
dollemod@nia.nih.gov
301-496-1752
NIH/National Institute on Aging
6-Nov-2002


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