Performance of the Reality polyurethane female condom and a synthetic latex prototype: a randomized crossover trial among South African women

Contraception
Mags E BeksinskaCarol Joanis

Abstract

This multisite, randomized, crossover trial comparing the performance of the Reality female condom (FC1) with a new synthetic latex prototype (FC2) was conducted in Durban, South Africa. In total, 276 women were enrolled and 201 women completed the study. Altogether, 1910 FC1 condoms and 1,881 FC2 condoms were used. Total breakage was 0.73% in FC1 and 0.85% in FC2 (95% confidence interval, -0.64 to 0.87). The number of clinical breakages (those that could result in a pregnancy or sexually transmitted infection) was similar for each condom type (FC1, n=9; FC2, n=8). Incorrect penetration (penis between condom and vaginal wall) was 1.26% and 0.64% for FC1 and FC2, respectively. Outer ring displacements (outer ring pushed into the vagina partially or fully) were comparable for both condoms (FC1, 3.14%; FC2, 2.98%). Slippage (condom came out of the vagina) was rare and reported in 0.37% or less of devices used. Total clinical failure was 5.24% in FC1 and 4.3% in FC2. The FC1 and FC2 performed comparably within this trial.

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Citations

Feb 22, 2012·Sexual Health·Mags E BeksinskaJoanne E Mantell
Feb 22, 2012·Sexual Health·Maria F GalloPatricia S Coffey
Nov 3, 2010·Substance Abuse : Official Publication of the Association for Medical Education and Research in Substance Abuse·Donald A CalsynMelinda Godinez
Apr 3, 2008·The Journal of Clinical Investigation·R John AitkenMichael J K Harper
Feb 24, 2011·AIDS Education and Prevention : Official Publication of the International Society for AIDS Education·Joanne E MantellZena A Stein
Jul 9, 2008·The European Journal of Contraception & Reproductive Health Care : the Official Journal of the European Society of Contraception·Maria Lameiras FernandezMarika L Foltz
Jan 2, 2009·The European Journal of Contraception & Reproductive Health Care : the Official Journal of the European Society of Contraception·Mags BeksinskaJabu Linda
Apr 14, 2012·The European Journal of Contraception & Reproductive Health Care : the Official Journal of the European Society of Contraception·Huang ZirongPei Hongbo
Sep 11, 2012·Current Problems in Pediatric and Adolescent Health Care·Lauren B HartmanLoris Y Hwang
Feb 12, 2011·Contraception·Carol JoanisJenni Smit
Mar 15, 2011·Contraception·Mags BeksinskaWilliam Potter
Nov 27, 2009·International Journal of Gynaecology and Obstetrics : the Official Organ of the International Federation of Gynaecology and Obstetrics·Li-Yan HouYi-Min Cheng
Nov 19, 2008·Contraception·Jill L SchwartzMarianne M Callahan
Mar 17, 2007·Contraception·Mags BeksinskaMargaret Usher-Patel
Dec 17, 2008·BJOG : an International Journal of Obstetrics and Gynaecology·S Rowlands
Dec 3, 2014·International Journal of Gynaecology and Obstetrics : the Official Organ of the International Federation of Gynaecology and Obstetrics·Xianmi WangYimin Cheng
Dec 3, 2014·Contraception·Mags BeksinskaCarol Joanis
Dec 19, 2012·Reproductive Health Matters·Mags BeksinskaWilliam Potter
Jun 18, 2014·Human Reproduction Update·UNKNOWN ESHRI Capri Workshop Group
Sep 20, 2019·International Journal of STD & AIDS·Mags BeksinskaVirginia Maphumulo
Feb 3, 2018·Archives of Sexual Behavior·Aaron J SieglerPatrick S Sullivan

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