QUANTIFY RETENTION OF NONOXYNOL IN OPEN LABEL, RANDOMIZED CROSS OVER STUDY

这是一项开放标签、随机、多次给药研究， 在选定的时间点保留在阴道中的壬苯聚醇-9（N-9）的量 滴注后的时间点。 五种不同的配方将被 研究（泡沫、2种凝胶、玻璃纸和栓剂）。 为每个 研究的制剂，至少4个保留时间点（2小时、4小时、8小时） 小时，和12小时）将进行研究。 对于Advantage凝胶制剂， 还将研究24小时时间点。 每例受试者将被随机分配接受总系列 其中一种产品配方的滴注。 对于每一种产品， 预计受试者将完成4次（或5次）滴注，1次 在每个指定的时间点滴注。 每次研究访视时 （间隔至少5天），将选择其中一个时间点 研究了 每位妇女将在随机的 研究访视期间指定的时间点。 对于每个主题，顺序 研究的时间点将随机分配。 最近的估计表明，在1000万至1200万艾滋病毒感染者中， 全世界的成年人通过异性恋感染了这种病毒。 性交（1）。截至1992年6月，异性性传播成为 艾滋病毒在美国传播给妇女的主要方式（2）。 目前，性行为的改变和屏障避孕的使用 是降低异性恋和同性恋比例的唯一方法 (male男性）传播这些感染。 事实上，男用避孕套， 经常和经常使用，已被证明有效地防止 怀孕（3）、人类免疫缺陷病毒（艾滋病毒）（4-6）和其他 性传播疾病（STDS）（7），并建议由 公共卫生服务，用于预防异性性传播 艾滋病毒（8）。 然而，重要的是每个人都有一个方法， 他或她可以使用作为个人保护，防止性病，包括艾滋病毒 （九）、 迄今为止，完成了90%的临床访视和80%的样本分析 已经发生了。 我们预计1997年5月完成/分析。

This is an open label, randomized, multiple dose study to quantify the amount of Nonoxynol-9 (N-9) retained in the vagina at selected timepoints after instillation. Five different formulations will be studied (foam, 2 types of gel, cellophane, and suppository). For each formulation studied, at least 4 timepoints of retention (2 hr, 4 hr, 8 hr, and 12 hrs) will be studied. For the Advantage gel formulation, a 24 hour timepoint will also be studied. Each subject will be randomly assigned to receive the total series of instillations for one of the product formulations. For each product, a subject will be expected to complete 4 (or 5) instillations, one instillation for each assigned timepoint. At each study visit (separated by at least 5 days) , ONE of the selected timepoints will be studied. Each woman will undergo a vaginal lavage at the randomly assigned timepoint during the study visit. For each subject, the order that the time points are studied will be randomly assigned. Recent estimates suggest that over 75% of the 10-12 million HIV-infected adults worldwide have contracted the virus through heterosexual intercourse (1) . As of June 1992, heterosexual transmission became the primary mode of transmission of HIV to women in the United States (2). Currently, changes in sexual behavior and use of barrier contraception are the only ways to reduce the rate of heterosexual and homosexual (male to male) spread of these infections. In fact, male condoms, when used consistently and regularly, have been proven effective to prevent pregnancy (3), Human Immunodeficiency Virus (HIV) (4-6) and other sexually transmitted diseases (STDS) (7) and are recommended by the Public Health Service for use to prevent heterosexual transmission of HIV (8). However, it is important that every individual have a method he or she can use as personal protection against STDS, including HIV (9). To date 90% of clinical visits are completed and 80% of sample analysis has occurred. We anticipate completion/analysis May of 1997.