Testimony to FDA on Testosterone

Endocrine Society Testimony to the Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee

"We recommend that treatment with testosterone be limited to men who meet established diagnostic guidelines for hypogonadism,, i.e., men who have clinical manifestations AND consistently low testosterone levels, and that treated patients be monitored as recommended by appropriate guidelines. We also recommend 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. Finally, we recommend that a large scale, well controlled study be conducted to assess long term cardiovascular and prostate risks associated with testosterone replacement treatment."

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