International Partnership for Microbicides, Silver Spring, MD.
MRU [Maternal, Adolescent and Child Health Research Unit], Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; and.
J Acquir Immune Defic Syndr. 2020 Sep 1;85(1):58-65. doi: 10.1097/QAI.0000000000002408.
The silicone Dapivirine Vaginal Ring 25 mg, has been developed to provide an additional HIV prevention option for women. If approved for use, women will always be counselled to use condoms when using the vaginal ring for maximum protection. This paper evaluates the compatibility of female condoms with the ring.
This was a 2-period crossover, randomized noninferiority trial. Couples in 2 sites in the United States of America were randomized to FC2 Female Condom (FC2) with and without a placebo silicone ring and asked to use 4 female condoms in each period. The primary noninferiority endpoint was the clinical failure rate during intercourse or withdrawal (self-reported clinical breakage, slippage, misdirection, and invagination). Frequencies and percentages were calculated for each failure mode and differences in performance of the 2 periods, using the female condom without the ring as reference. Noninferiority was defined using an 8% margin at the 5% significance level. Safety and tolerability were also assessed.
Eighty-one couples were enrolled and 79 completed the trial using a total of 596 female condoms (297 and 299 with/without a ring inserted, respectively). Total female condom clinical failure was 14.1% and 15.7% in the presence and absence of a ring, respectively, with a difference of -2.1% (95% confidence interval: -7.8% to 3.6%), thereby demonstrating noninferiority when used with the ring. There were no differences in safety and tolerability between the 2 periods.
Concurrent use of the placebo silicone vaginal ring had no significant effect on female condom functionality or safety outcomes.
硅基 25 毫克 dapivirine 阴道环的研发，旨在为女性提供另一种艾滋病病毒预防选择。如果获准使用，当女性使用阴道环时，始终会被建议同时使用避孕套以获得最大保护。本文评估了女性避孕套与阴道环的兼容性。
这是一项 2 期交叉、随机非劣效性试验。美国的 2 个地点的夫妇被随机分为 FC2 女性避孕套（FC2）加和不加安慰剂硅酮环，并要求在每个时期使用 4 个女性避孕套。主要非劣效性终点是性交或退出期间的临床失败率（自我报告的临床破裂、滑脱、错位和内陷）。计算了每种失败模式的频率和百分比，并使用不戴环的女性避孕套作为参考，比较了两个时期的表现差异。非劣效性定义为在 5%的显著性水平下 8%的差异。还评估了安全性和耐受性。
81 对夫妇入组，79 对夫妇完成了总共使用 596 个女性避孕套（分别有 297 个和 299 个插入环）的试验。有环和无环时女性避孕套的总临床失败率分别为 14.1%和 15.7%，差异为-2.1%（95%置信区间：-7.8%至 3.6%），因此在使用环时表现出非劣效性。两个时期的安全性和耐受性没有差异。
同时使用安慰剂硅酮阴道环对女性避孕套的功能或安全性结果没有显著影响。
