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SIX-MONTH CONTRACEPTIVE EFFICACY TRIALS ARE ADEQUATE FOR BARRIER METHODS

This article was originally published in The Gray Sheet

Executive Summary

SIX-MONTH CONTRACEPTIVE EFFICACY TRIALS ARE ADEQUATE FOR BARRIER METHODS of preventing pregnancy, scientists participating in an April 6-8 FDA/National Institutes of Health/Centers for Disease Control and Prevention workshop on contraceptive efficacy and sexually transmitted disease prevention concluded. Speaking on the final day of the meeting, Jeffrey Spieler, of U.S.A.I.D., said "for all barrier methods, male and female barriers...the group agreed that six-month clinical trials [for prevention of pregnancy] would be sufficient" to gather the necessary safety and efficacy data to bring a product to market.
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