Critical next steps for female condom research : report from a workshop

In addition to a standard slippage and breakage study the United States Food and Drug Administration (USFDA) currently requires a contraceptive effectiveness trial to be carried out as part of the pathway to regulatory approval for new female condoms. In an attempt to explore acceptable alternatives to expensive and resource-consuming Phase 3 contraceptive effectiveness trials the United States Agency for International Development (USAID) recently requested that CONRAD organize a 1-day meeting of investigators in the female condom and semen biomarker fields. The charge to the group was to devise a study design that would validate a biomarker against a biological end point such as pregnancy or a sexually transmitted infection (STI) so that the validated marker could be used to augment a slippage and breakage study for approval of new female condoms eliminating the need for the currently required contraceptive effectiveness trial. The meeting was entitled "Critical Next Steps for Female Condom Research - A Meeting/Workshop" and was convened by CONRAD in Arlington VA on July 8 2008 with USAID support. Afterward a working group of clinical researchers continued deliberations via teleconference and wrote the following report. After exploring the pros and cons of several biological markers prostate-specific antigen (PSA) was identified as the most promising one to pursue for this application because of the extensive previous work involving that marker. (excerpt)