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The Endocrine Society responds to Institute of Medicine report on testosterone therapy for older men

re, these trials should be coordinated, in order to provide for standardization of data collection across sites and aggregate data analysis, and pooling of short-term risk.
  • Conduct longer-term studies if short-term efficacy is established.
  • Ensure the safety of research participants.
  • Conduct further research to investigate physiologic regulation, mechanism of action and age-related changes in testosterone levels.

    The IOM recommends that initial studies be conducted in men over the age of 65 who have low serum testosterone levels and at least one symptom that might be related to low testosterone. Endocrinologists have played a crucial and leading role in defining the clinical manifestations of androgen deficiency, developing appropriate and sensitive assay methods to measure testosterone concentrations in blood and developing and testing testosterone formulations for therapy of men with hypogonadism, a condition characterized by low testosterone levels. The Endocrine Society notes that several factors should be considered when setting up the protocol for the measurement of testosterone in study participants. One of the issues addressed in the IOM detailed report pertains to the definition of a "normal range" for testosterone in healthy men. Currently, reference range varies depending on the type and manufacturer of the test used for measurement. Since a primary criterion for selection of study participants is a low testosterone level, it will be crucial to address the problem of lack of standardization in reference range for serum testosterone. Also, it is unclear what level of testosterone should be considered low and associated with disability or symptoms. In addition to this area of concern, it will also be important to include other tests in the laboratory measurements obtained for each study participant. Total testosterone levels may be affected by several factors including the level of protein in the blood that trans
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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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