STANDARDIZED PROTOCOLS FOR CONDOM BREAKAGE AND SLIPPAGE TRIALS - A PROPOSAL

In the absence of well-controlled studies on the clinical effectivenes s of condoms against pregnancy and sexually transmitted diseases, brea kage and slippage data may provide the best indication of the protecti on offered by condom use. According to the recent literature, condom b reakage rates range from 0% to 12%, with many US studies falling in th e 2% to 5% range. Few studies have collected slippage data. In additio n to discussing methodological issues associated with these studies, w e propose a standardized protocol for future condom breakage and slipp age trials and discuss how results may be used to estimate perfect-use and typical-use pregnancy rates.