Background: The Woman's Condom, a second-generation female condom, is poised for introduction in China.
Study design: This single-arm couples' use study was conducted in China in 2010 to assess performance and safety of the Woman's Condom and feasibility of mobile phone technology to record adherence data.
Results: Sixty couples were enrolled in this study, and 59 couples completed all four of the condom uses, resulting in 234 condom uses. Two condoms were opened but not used. Total breakage was 0.85% (two non-clinical breakages). Misdirection (2%), invagination (0.85%) and slippage (1%) were consistent with data on condom failure from other studies. Total clinical failure was 4%. Fifteen mild and no serious adverse events were reported during the study.
Conclusions: This study has shown that in China, the Woman's Condom performs well. Mobile phones cannot yet replace the use of a coital log and questionnaire. Further work on effectiveness is required.