Comparison of self-reported female condom failure and biomarker-confirmed semen exposure

Contraception
Terri L WalshMark A Weaver

Abstract

To investigate whether rates of self-reported Woman's Condom (WC) clinical failure and semen exposure from a functionality study are comparable to results from a contraceptive efficacy substudy. We structured our comparative analysis to assess whether functionality studies might credibly supplant contraceptive efficacy studies when evaluating new female condom products. Couples not at risk of pregnancy in the functionality (breakage/slippage/invagination/penile misdirection) study and women in the contraceptive efficacy study completed condom self-reports and collected precoital and postcoital vaginal samples for up to four uses of the WC. Both studies used nearly identical self-report questions and the same self-sampling procedures and laboratory for prostatic specific antigen (PSA), a well-studied semen biomarker. We compared condom failure and semen exposure proportions using generalized estimating equations methods accounting for within-couple correlation. Ninety-five (95) efficacy substudy participants used 334 WC and 408 functionality participants used 1572 WC. Based on self-report, 19.2% WC (64 condoms) clinically failed in the efficacy substudy compared to 12.3% WC (194 condoms) in the functionality study (p=.03). Of th...Continue Reading

References

Oct 17, 1998·Sexually Transmitted Diseases·M L LawsonR Blackwell
Feb 13, 2003·American Journal of Epidemiology·M Louise LawsonAmy Bloom
Feb 13, 2003·American Journal of Epidemiology·Maurizio MacalusoAmy Bloom
Jul 26, 2006·Sexually Transmitted Diseases·Maria F GalloMyron S Cohen
Mar 17, 2007·Contraception·Mags BeksinskaMargaret Usher-Patel
May 24, 2007·Contraception·Christine K MauckUNKNOWN Biomarkers of Semen Exposure Clinical Working Group
May 16, 2008·American Journal of Clinical Pathology·Patricia R SlevWilliam L Roberts
Apr 4, 2009·Contraception·Christine K MauckCarol Joanis
Oct 1, 2014·Journal of Women's Health·Margaret Christine SneadAthena P Kourtis
Jul 18, 2017·Contraception·Andrzej KulczyckiMaurizio Macaluso

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