Functional performance study of an adapted design of the woman’s condom: a crossover, noninferiority, randomized clinical trial

Abstract

Objectives: We aimed to assess the functional performance and safety of a modified Woman’s Condom (WC2) against the existing FC2 female condom.

Study design: 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.

Results: 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 (p = .000), total female condom failure (p = .001), misdirection (p = .000) and slippage (p = .004).

Conclusion: The WC2 female condom performs as well as the FC2 female condom and offers good stability during use.

Implications: Results from this study will inform further refinement of this female condom design, resulting in a new and potentially less expensive Woman’s Condom.

摘要

目的：评估一种改进型女用避孕套（WC2）与现有FC2女用避孕套的性能和安全性。

研究设计：这项随机临床试验在南非的一个地点招募了287名妇女。这项研究的主要结果是女性避孕套的失败率。参与者使用五种不同类型的女用避孕套, 并在家里收集避孕套使用记录, 并在使用每种FC类型的避孕套后接受采访。

结果：WC2与参考避孕套FC2相比, 其所有功能均表现出非劣效性。WC2的各项性能指标均优于FC2, 在临床失败率（p= .000）、女用避孕套完全失效（p= .001）、精液逆流（p= .000）和脱落（p= .004）等方面, WC2优于FC2标准避孕套。

结论：WC2女用避孕套性能与FC2女用避孕套相同, 使用时稳定性好。

意义：这项研究的结果将进一步完善这种女用避孕套的设计, 从而产生一种新的、更便宜的女用避孕套。

Keywords:

• Female condom
• condom function
• barrier methods
• safety

Acknowledgements

We would like to thank the staff of the clinic site for support of the study in their facility and we would like to thank the study participants for their cooperation and participation and without whose dedication this study would not have been possible.

Disclosure statement

For part of the study period, PSC and MKB led the Protection Options for Women Product Development Partnership (2011–2015), which was dedicated to expanding access to the Woman’s Condom. There are no conflicts of interest for the other authors during the study period.

Additional information

Funding

This trial was funded by the Universal Access to Female Condoms (UAFC) Joint Programme, iPlus Solutions and PATH (through a grant from the Netherlands Ministry of Foreign Affairs).