Mauck Christine K, Weiner Debra H, Creinin Mitchell D, Barnhart Kurt T, Callahan Marianne M, Bax Richard
CONRAD, Eastern Virginia Medical School, 1611 North Kent Street, Arlington, VA 22209, USA.
Contraception. 2004 Sep;70(3):233-40. doi: 10.1016/j.contraception.2004.04.010.
C31G is an antimicrobial and spermicidal agent that contains two surface-active compounds, cetyl betaine and myristamine oxide. It is being developed as a vaginal microbicide and contraceptive.
Three C31G concentrations (0.5%, 1.0% and 1.7%) were tested and compared with Extra Strength Gynol II(R), a marketed spermicide containing 3% nonoxynol-9 (N-9), in a randomized, double-blinded, Phase I, dose-escalation study to assess genital irritation (by subject report, visual examination at pelvic examination and colposcopy), plasma and vaginal lavage levels of C31G, product leakage, systemic safety and acceptability. Women were randomized to use 3.5 mL of one of the three C31G products or the N-9 gel at night for 7 days then twice daily for another 7 days. Pelvic and colposcopic evaluations were performed after 7 and 14 days of product use.
The percent of women experiencing irritation in the 0.5% and 1.0% C31G groups in the study were similar to each other and were lower than the percent experiencing irritation in the 1.7% and N-9 groups, which were also similar to each other. Differences were statistically significant between 1.0% C31G vs. N-9 at 7 days and between 0.5% C31G and 1.0% C31G vs. N-9 at 14 days. There was no significant difference between groups in leakage or acceptability. No C31G was detected in the plasma of any volunteer.
These results suggest that 0.5% and 1.0% C31G are less irritating to the female genital tract than 1.7% C31G or Extra Strength Gynol II.
C31G是一种抗菌和杀精剂，含有两种表面活性化合物，十六烷基甜菜碱和肉豆蔻胺氧化物。它正被开发用作阴道杀菌剂和避孕药。
在一项随机、双盲、I期剂量递增研究中，测试了三种C31G浓度（0.5%、1.0%和1.7%），并与市售含3%壬苯醇醚-9（N-9）的强力Gynol II进行比较，以评估生殖器刺激（通过受试者报告、盆腔检查和阴道镜检查的视觉检查）、C31G的血浆和阴道灌洗水平、产品泄漏、全身安全性和可接受性。女性被随机分配在晚上使用三种C31G产品之一或N-9凝胶3.5 mL，持续7天，然后每天两次，再持续7天。在使用产品7天和14天后进行盆腔和阴道镜评估。
研究中0.5%和1.0% C31G组出现刺激的女性百分比彼此相似，且低于1.7%和N-9组出现刺激的女性百分比，后两组也彼此相似。在第7天，1.0% C31G与N-9之间以及在第14天，0.5% C31G和1.0% C31G与N-9之间的差异具有统计学意义。各组在泄漏或可接受性方面无显著差异。在任何志愿者的血浆中均未检测到C31G。
这些结果表明，0.5%和1.0% C31G对女性生殖道的刺激性低于1.7% C31G或强力Gynol II。
