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Medical News and Perspectives
February 26, 2003

Many Questions, Few Answers for Testosterone Replacement Therapy

JAMA. 2003;289(8):971-972. doi:10.1001/jama.289.8.971

Washington—The Web site advertisement would pique the interest of just about any man. As an animated gas gauge needle drops, questions appear. "Fatigued?" asks the ad. "Depressed mood? Low sex drive? Could be your testosterone is running on empty!"

The ad is from Unimed Pharmaceuticals Inc, the Marietta, Ga, marketer of a testosterone gel whose sales quadrupled to $144 million worldwide in 2001.

Approved by the US Food and Drug Administration (FDA) for hypogonadism, or clinically low testosterone in otherwise healthy men, testosterone replacement products are arousing concern from researchers who question a lack of data on long-term safety. So much so, in fact, that the Institute of Medicine (IOM) has been called on to help design large-scale studies.

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