Abstract：
Advantage 24 is a new contraceptive gel that makes use of bioadhesive technology to offer 24 hours of protection relying on the spermicide nonoxynol-9 (N-9) in lower concentrations. If a proposed US Food and Drug Administration (FDA) rule is enforced N-9 may be examined closely. The manufacturer, Whitehall-Robins Healthcare in New Jersey, stopped production of the Today contraceptive sponge because of the costs of complying with FDA standards. The Advantage 24 gel costs twice as much as the sponge. It is made in Switzerland and distributed by an Illinois company. Any vaginal contraceptive containing N-9 would be approved by the FDA as long as it complied with guidelines laid down in an FDA monograph. However, the registration of the gel could not be confirmed. The product uses a bioadhesive technology concept that natural substances adhere to epithelial and mucosal tissues in the body. Polycarbofil is mixed with water, N-9, and mineral oil to create an emulsion that allows for a time-release mechanism, but at any given time only 2 mg of N-9 is available to kill sperm. The final formula for Advantage 24 is 52.5 mg per dose. Too much N-9 can be toxic, as demonstrated by the Today sponge, which contained 1000 mg of N-9. In Kenya prostitutes using it frequently experienced 3 times as many genital lesions as those using a placebo. A study of Advantage 24 by a Miami laboratory involved 250 women, 22-45 years old, who had had prior tubal ligations. When the gel was applied 15-30 minutes before intercourse the efficacy rate was 98%; it was 91% for those applying it 12 hours before; and it was 86% when the gel was applied 24 hours ahead of time. FDA compliance officers are intrigued about the claim that the gel lasts 24 hours. However, if the claim is held up by research data, women will have an easily available, portable, efficient, aesthetic, and highly effective contraceptive.
摘要：
优势24是一种新的避孕凝胶，它利用生物粘附技术提供24小时的保护，依赖于低浓度的杀精子剂nonoxynol-9（N-9）。如果拟议的美国食品和药物管理局（FDA）规则被强制执行，则可以仔细检查N-9。制造商，新泽西州的白厅-罗宾斯医疗保健，由于符合FDA标准的成本，今天停止生产避孕海绵。优势24凝胶的成本是海绵的两倍。它在瑞士制造，由伊利诺伊州的一家公司分销。任何含有N-9的阴道避孕药都将得到FDA的批准，只要它符合FDA专论中规定的指南。然而,无法确认凝胶的注册。该产品使用生物粘附技术概念，即天然物质粘附在体内的上皮和粘膜组织上。聚卡必非与水混合,N-9和矿物油，以创建允许时间释放机制的乳液，但在任何给定时间，只有2毫克的N-9可用于杀死精子。优势24的最终配方为每剂量52.5mg。太多的N-9可能有毒，正如今天的海绵所证明的那样，其中含有1000毫克的N-9。在肯尼亚，使用它的妓女经常经历3倍于使用安慰剂的生殖器病变。迈阿密实验室对优势24的研究涉及250名女性，22-45岁,之前有过输卵管结扎的人。当在性交前15-30分钟施用凝胶时,效力率为98%;对于12小时前施用凝胶的人,效力率为91%;并且当提前24小时施用凝胶时,效力率为86%。FDA合规官员对凝胶持续24小时的说法很感兴趣。然而,如果索赔被研究数据搁置，女人会有一个很容易获得的，便携式，高效,美学，和高效的避孕药。
