目的:这项多中心前瞻性研究(BZK40+)旨在确定含有苯扎氯铵的杀精子剂作为40岁及以上女性避孕药的疗效和耐受性。
方法:这项开放性单臂研究的育龄妇女被指示在每次性交前系统地使用苯扎氯铵杀精子剂。在6个月的强制期结束时,参与者可以选择再继续研究6个月.避孕效果的主要终点是珍珠指数(PI),直到12个月的典型使用。
结果:共招募了151名女性(平均年龄:45.9岁),144(95.4%)完成了最初的6个月期间,63(41.7%)完成了可选的6个月期间。交往次数的中位数为每月3至5次。在5,895次性交中,有96.3%使用了杀精子剂。典型使用12个月的PI为0次妊娠(95%置信区间:0-2.88)。累积治疗暴露量为1249.7个妇女月。
结论:这项针对40岁及以上女性的首次研究表明,苯扎氯铵杀精剂(Pharmatex®)是有效的,在这个人群中很好的耐受性和接受。虽然很有趣,在PI等于零的情况下,这些结果令人惊讶,并不符合世卫组织在总体人群中使用杀精剂的低疗效.所以,我们的结果应谨慎解释,并由未来的研究证实.临床试验登记号(EudraCT):2016-004188-38。
OBJECTIVE: This multicenter prospective
study (BZK40+) aims to determine the efficacy and tolerance of a benzalkonium chloride-containing spermicide as contraceptive among women aged 40 and over.
METHODS: Fertile women enrolled in this open single-arm
study were instructed to systematically use the benzalkonium chloride spermicide before each intercourse. At the end of a 6-month mandatory period, participants were given the option of continuing the
study for a further 6 months. The primary endpoint for contraceptive efficacy was the Pearl Index (PI) up to 12 months of typical use.
RESULTS: A total of 151 women (mean age: 45.9 years) were enrolled, 144 (95.4%) completed the initial 6-month period and 63 (41.7%) completed the optional 6-month period. The median number of intercourses ranged from 3 to 5 per month. The spermicide was applied before 96.3% of the 5,895 sexual intercourses. The PI up to 12 months of typical use was 0 pregnancies (95% confidence interval: 0-2.88). The cumulative treatment exposure was 1249.7 women-months.
CONCLUSIONS: This first
study in women aged 40 years and over shows that benzalkonium chloride spermicide (Pharmatex®) is effective, well tolerated and well accepted in this population. Although very interesting, these results with a PI equal to zero are surprising and not in accordance with the low efficacy of spermicides in the overall population according to the WHO. So, our results should be interpreted with caution and confirmed by future research. Clinical
trial registration number (EudraCT): 2016-004,188-38.