Beksinska Mags, Greener Ross, Mphili Nonhlanhla, Smit Jenni, Kilbourne-Brook Maggie, Coffey Patricia S
a MRU (MatCH Research Unit), Department of Obstetrics and Gynaecology, Faculty of Health Sciences , University of the Witwatersrand , Durban , South Africa.
b PATH , Seattle , WA , USA.
Eur J Contracept Reprod Health Care. 2019 Jun;24(3):233-239. doi: 10.1080/13625187.2019.1610940. Epub 2019 May 21.
We aimed to assess the functional performance and safety of a modified Woman's Condom (WC2) against the existing FC2 female condom. This randomized clinical trial enrolled 287 women in one South African site. The primary outcome of the study was the rate of female condom failure. Participants were asked to use five of each female condom type and to collect information on use in a condom log at home and were interviewed after use of each FC type. Noninferiority was demonstrated for the WC2 with respect to the reference condom FC2 for all condom functions. The WC2 was found to be superior to the FC2 reference condom for clinical failure ( = .000), total female condom failure ( = .001), misdirection ( = .000) and slippage ( = .004). The WC2 female condom performs as well as the FC2 female condom and offers good stability during use. Results from this study will inform further refinement of this female condom design, resulting in a new and potentially less expensive Woman's Condom.
我们旨在评估改良版女性避孕套（WC2）相对于现有FC2女性避孕套的功能表现和安全性。这项随机临床试验在南非的一个地点招募了287名女性。该研究的主要结局是女性避孕套失败率。参与者被要求每种女性避孕套各使用五个，并在家用避孕套使用记录中收集使用信息，且在使用每种FC型避孕套后接受访谈。在所有避孕套功能方面，WC2相对于对照避孕套FC2显示出非劣效性。发现WC2在临床失败（P = .000）、女性避孕套总失败（P = .001）、误置（P = .000）和滑脱（P = .004）方面优于FC2对照避孕套。WC2女性避孕套的性能与FC2女性避孕套相当，且在使用过程中具有良好的稳定性。这项研究的结果将为进一步改进这种女性避孕套设计提供依据，从而产生一种新的、可能成本更低的女性避孕套。
