Endocrine Society Tells FDA Testosterone Therapy Should Only Be for Men with Hypogonadism

Contact: Aaron Lohr
Director, Media Relations
Phone: 202.971.3654
alohr@endocrine.org
Contact: Jenni Glenn Gingery
Manager, Media Relations
Phone: 202.971.3655
jgingery@endocrine.org

Washington, DC—The Endocrine Society testified today at a meeting of the Food and Drug Administration (FDA) discussing the appropriate population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with its use. Though testosterone use has sharply increased among older men in the past decade, the Society told the FDA that testosterone therapy should be limited to men who meet the diagnostic guidelines for hypogonadism.

Testosterone is a key male sex hormone involved in maintaining sex drive, sperm production and bone health. Since testosterone levels tend to naturally decline as men age, lower levels of the hormone do not necessarily mean that an individual has hypogonadism, a condition that results from low testosterone. Clinical manifestations of hypogonadism may include decreased libido, erectile dysfunction, breast enlargement and infertility.

Testifying before the FDA joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on behalf of the Endocrine Society, Ronald Swerdloff, MD, professor at the David Geffen School of Medicine at UCLA, said testosterone treatment should be limited to men who have clinical manifestations of hypogonadism and consistently low testosterone levels.

“The Endocrine Society also recommends that more data be collected on men of different ages to better establish the serum testosterone thresholds for specific organ-related symptoms and signs, and to determine which clinical manifestations will benefit from replacement testosterone therapy,” Swerdloff testified.

The Society further recommended that a large-scale, well-controlled study be conducted to assess long term cardiovascular and prostate risks associated with testosterone replacement treatment.

Dr. Swerdloff was an author of the Endocrine Society’s clinical practice guideline, “Testosterone Therapy in Adult Men with Androgen Deficiency Syndromes.”

# # #

Founded in 1916, the Endocrine Society is the world’s oldest, largest and most active organization devoted to research on hormones and the clinical practice of endocrinology. Today, the Endocrine Society’s membership consists of over 17,000 scientists, physicians, educators, nurses and students in more than 100 countries. Society members represent all basic, applied and clinical interests in endocrinology. The Endocrine Society is based in Washington, DC. To learn more about the Society and the field of endocrinology, visit our site at www.endocrine.org. Follow us on Twitter at https://twitter.com/#!/EndoMedia.