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testosterone therapy for older men
benefits for ageing men from hormone treatments The Endocrine Society is the largest and most active professional organization of endocrinologists in the world, today the society announced its support for the Institute of Medicine (IOM) report titled Testosterone and Aging: Clinical Research Directions.
This 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 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.
- 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. Furthermore, 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.
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.
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