Endocrine Society Seeks to Conduct Studies for Testosterone Therapy Risks

The Endocrine Society, the world's oldest, largest and most active organization devoted to research on hormones and the clinical practice of endocrinology, issued a statement yesterday that called for the evaluation of the benefits and risks of testosterone therapy.

Their concern is in regards to the safety of testosterone therapy in older men with a history of heart disease. They believe that prior to being treated for declining levels of testosterone, such patients need to be fully evaluated. The Veterans Health Care System as well as the National Institutes of Health recently uncovered evidence that men who received testosterone treatments and had preexisting heart issues experienced a higher rate of such cardiovascular events. As a result of these findings, the U.S. Food and Drug Administration declared it plans to further study the benefits and risks of testosterone therapy.

Testosterone is clinically approved for the treatment of hypogonadism, which negatively affects the functional activity of the gonads in men and women. The testosterone treatment is more common in men. Hypogonadism is known to contribute to diseases in the testes, pituitary, and hypothalamus. Although testosterone is approved to treat for the effects of hypogonadism, it has yet to be approved for age-related symptoms of lower testosterone levels.

The National Institute on Aging is currently conducting a randomized trial that is examining 800 older men with low testosterone levels. The study is expected to provide important safety data for the issue brought forth by the Endocrine Society.

A statement from the Endocrine Society acknowledged that testosterone therapy is safe for young men with hypogonadal conditions, but older men who are experience issues to do age-related effects should be extensively evaluated and notified of the potential cardiovascular risks. Treatment for low testosterone is not suggested for men who have had a cardiovascular event within the last six months.

To read more about this issue, visit the Endocrine Society's Clinical Practice Guideline on testosterone therapy as well as this EurekAlert! article.