McClure D A, Edelman D A
Adv Contracept. 1985 Dec;1(4):305-11. doi: 10.1007/BF01849305.
The Today vaginal contraceptive sponge is made of polyurethane and contains 1 gram of the spermicide nonoxynol-9. Following preclinical and phase I and II clinical trials, extensive worldwide phase III trials were conducted. These multiclinic trials were conducted according to a common protocol with regularly scheduled follow-up visits and examinations. The cumulative first year method effectiveness rate (life table) was 90 per 100 women. The second year rate was 97 per 100 women. No statistically significant difference was found in method failures between nulliparous and parous women. No serious complications occurred in over 1000 women-years of sponge use.
今日牌阴道避孕海绵由聚氨酯制成,含有1克杀精剂壬苯醇醚-9。在进行临床前试验以及I期和II期临床试验后,在全球范围内开展了广泛的III期试验。这些多中心试验按照共同方案进行,有定期安排的随访和检查。累积的第一年方法有效率(生命表)为每100名女性中有90人有效。第二年的有效率为每100名女性中有97人有效。未生育女性和已生育女性在方法失败率上未发现统计学上的显著差异。在超过1000女性年的海绵使用中未发生严重并发症。