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Scientists Recommend New Design for Female Condom ResearchAs the result of a USAID-supported workshop organized by the nonprofit organization CONRAD, scientists have proposed a new design for studies testing the effectiveness of innovations in the female condom. For a female condom to gain regulatory approval in the United States, the U.S. Food and Drug Administration (FDA) currently requires that the product be tested in a large -- and often expensive -- phase III contraceptive-effectiveness trial. CONRAD held the workshop specifically so that experts on female condoms and semen biomarkers could explore acceptable alternatives to this type of trial. The experts identified the well-studied biomarker prostate-specific antigen (PSA) as the most promising marker to pursue for this application. The new study design uses PSA to show the presence of semen in the vagina, which should be a more reliable indicator of clinical condom failure than is the incidence of pregnancy or a sexually transmitted infection. A report of the workshop and the details of the study design are published in the journal Contraception. The authors of the report are affiliated with the following institutions:
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