Assessing the Need for Clinical Trials of Testosterone Replacement Therapy in Older Men

Type: Consensus Study
Topics: Biomedical and Health Research, Diseases, Public Health
Board: Board on Health Sciences Policy

Activity Description

This study reviewed and assessed the current state of knowledge related to the potential beneficial and adverse health effects of testosterone replacement therapy (TRT) in older men, and made recommendations regarding clinical trials of TRT intervention that are needed including the parameters that should be considered in study design and conduct.

The committee reviewed and considered epidemiologic data on normal levels of testosterone during the lifespan and the associations with morbidity and mortality; the risks and benefits of testosterone replacement therapy; the potential public health impact of TRT in the United States; and the ethical issues related to the conduct of a clinical trial of TRT. The committee's report included recommendations on the design and conduct of a large-scale clinical trial on testosterone replacement therapy in older men if such a study is deemed to be advisable.

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