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A drug for women tested mostly in men

Yale Medicine Magazine, 2016 - Winter


Some scientists see a major flaw in a recent study of the effects of alcohol consumption on a drug intended only for women.

The study of interactions between alcohol and Addyi, the first drug to treat female sexual dysfunction, enrolled 23 men—and two women.

“There is no valid reason to ignore the well-established biological and behavioral differences between men and women when conducting biomedical research,” said Carolyn M. Mazure, Ph.D., director of Women’s Health Research at Yale. “Yet it continues to happen.”

Sprout Pharmaceuticals, which markets Addyi, said in a statement that the study was designed with FDA guidance. “More men than women agreed to enroll in this kind of study,” the statement said, adding that Sprout plans to conduct additional studies on the effects of alcohol in women.

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