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Gays Not Allowed to Participate in Some Trials

Studies with sexual function end point are particularly likely to exclude lesbians and gay men

WEDNESDAY, March 17 (HealthDay News) -- Some clinical trials explicitly exclude lesbians and gay men, according to a letter published in the March 18 issue of the New England Journal of Medicine.

To identify studies explicitly excluding lesbians and gay men, Brian L. Egleston, Ph.D., of the Fox Chase Cancer Center in Philadelphia, and colleagues searched the database using the terms "couples," "erectile dysfunction" and "hypoactive."

The researchers identified 243 studies, including 37 (15 percent) containing explicit exclusionary language that restricted trials to heterosexual participants. They found that the trials most likely to exclude lesbians and gay men were industry-sponsored, multiregional and phase 3. Variables not associated with exclusionary criteria included the year the study opened, whether the study was open to people older than 65 years, and whether the study accepted healthy volunteers.

"Our results indicate that exclusion of lesbians and gay men from clinical trials in the United States is not uncommon, particularly in studies with sexual function as an end point," the authors conclude. "It is likely that most gay and lesbian patients are unaware that their sexual orientation is being used as a screening factor for participation in clinical trials. Researchers should be held to careful scientific reasoning when they develop exclusion criteria that are based on sexual orientation."

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