Mauck C K, Allen S, Baker J M, Barr S P, Abercrombie T, Archer D F
Contraceptive Research and Development (CONRAD) Program, Eastern Virginia Medical School, Arlington, USA.
Contraception. 1997 Aug;56(2):103-10. doi: 10.1016/s0010-7824(97)00100-5.
The objectives of this study were to determine the amount of nonoxynol-9 (N-9) remaining in the vagina 30 min and 1, 1.5, 2, and 4 h after vaginal insertion of a single sheet of VCF containing 70 mg N-9 and to compare these results to the manufacturer's instructions for use of this product. A new method of vaginal lavage was used to obtain samples for N-9 determination. This was an open-label, noncomparative, pharmacokinetic study in 12 healthy women volunteers not at risk for pregnancy. The study consisted of a screening visit followed by five test visits approximately 1 month apart and a final visit 1 week after all test visits were completed. At each test visit, the investigator inserted a single sheet of VCF in the vagina of the volunteer at midcycle. The volunteer remained in the clinic and underwent vaginal lavage with normal saline after one of five specified time intervals had elapsed. The sequence of the intervals completed by each volunteer was determined by randomization. When undissolved film was found in the vagina, it was removed prior to lavage and assayed for N-9 content separately from that recovered in lavage fluid. It was assumed that the N-9 in undissolved film would not contribute significantly to sperm immobilization. Between 18.5 and 28.5 mg of N-9 were recovered in lavage fluid after intervals of 0.5, 1, 1.5, and 2 h. These levels did not differ statistically (p > 0.05). The amount of N-9 recovered dropped significantly at 4 h to 11.0 mg. If it is assumed that an N-9 concentration of 0.100 mg/mL is required to immobilize sperm in vitro, this study suggests that the amount of N-9 remaining in the vagina in the form of dissolved film up to 4 h after insertion of VCF is sufficient to immobilize sperm. The lavage procedure may not have recovered all N-9 remaining in the vagina. However, intercourse did not take place between insertion and lavage; if it had, the proportion of the film remaining undissolved and the total amount N-9 remaining in the vagina at the time of examination might have been affected.
本研究的目的是测定在阴道内插入一片含70mg壬苯醇醚-9（N-9）的阴道避孕海绵（VCF）后30分钟以及1、1.5、2和4小时时阴道内剩余的N-9量，并将这些结果与该产品制造商的使用说明进行比较。采用一种新的阴道灌洗方法获取用于测定N-9的样本。这是一项针对12名无妊娠风险的健康女性志愿者的开放标签、非对照药代动力学研究。该研究包括一次筛查访视，随后是大约相隔1个月的五次测试访视，以及在所有测试访视完成后1周的末次访视。在每次测试访视时，研究人员在月经周期中期将一片VCF插入志愿者阴道。志愿者留在诊所，在经过五个指定时间间隔之一后，用生理盐水进行阴道灌洗。每个志愿者完成的时间间隔顺序通过随机化确定。当在阴道中发现未溶解的薄膜时，在灌洗前将其取出，并与灌洗液中回收的N-9分别进行N-9含量测定。假定未溶解薄膜中的N-9对精子固定作用的贡献不大。在0.5、1、1.5和2小时的时间间隔后，灌洗液中回收的N-9为18.5至28.5mg。这些水平在统计学上无差异（p>0.05）。在4小时时，回收的N-9量显著下降至11.0mg。如果假定在体外固定精子需要0.100mg/mL的N-9浓度，那么本研究表明，插入VCF后长达4小时以溶解薄膜形式留在阴道内的N-9量足以固定精子。灌洗程序可能并未回收留在阴道内的所有N-9。然而，在插入和灌洗之间未发生性交；如果发生了性交，检查时剩余未溶解薄膜的比例以及留在阴道内的N-9总量可能会受到影响。
