Coutinho E M, Mascarenhas I, de Acosta O M, Flores J G, Gu Z P, Ladipo O A, Adekunle A O, Otolorin E O, Shaaban M M, Abul Oyoon M
Maternidade Climério de Oliveira, Federal University of Bahia, Salvador, Bahia, Brazil.
Clin Pharmacol Ther. 1993 Nov;54(5):540-5. doi: 10.1038/clpt.1993.186.
The objective of this multicenter randomized clinical trial was to compare the efficacy, acceptability, and occurrence of side effects associated with the oral versus vaginal route of administration of contraceptive pills. Eight hundred nineteen healthy, parous women of reproductive age were recruited at family planning clinics and research centers, members of the South to South Cooperation in Reproductive Health, in seven countries of the developing world. These women were randomly assigned to use either oral or vaginal administration of the same contraceptive pill, which contained 250 micrograms levonorgestrel and 50 micrograms ethinyl estradiol. No statistically significant differences were found in discontinuation rates between the two groups after 1 year. Involuntary pregnancy rates after 1 year were not statistically significantly different between the two groups. The vaginal route of administration appears to be as acceptable and efficacious as the oral route.
这项多中心随机临床试验的目的是比较口服避孕药与阴道给药避孕药在疗效、可接受性及副作用发生情况方面的差异。在发展中世界七个国家的计划生育诊所和研究中心（南南生殖健康合作组织成员）招募了819名健康的经产妇。这些妇女被随机分配使用含有250微克左炔诺孕酮和50微克炔雌醇的同一种避孕药的口服或阴道给药方式。1年后，两组的停药率没有统计学上的显著差异。1年后两组的意外怀孕率在统计学上也没有显著差异。阴道给药途径似乎与口服途径一样可接受且有效。
