Coutinho E M, de Souza J C, da Silva A R, de Acosta O M, Alvarez F, Brache V, Garza Flores J, Vasquez-Estrada L, Santo R, Bassol S
Maternidade Climério de Oliveira, Federal University of Bahia, Salvador, Brazil.
Clin Pharmacol Ther. 1993 Jan;53(1):65-75. doi: 10.1038/clpt.1993.10.
The efficacy and acceptability of two widely used oral contraceptive tablets, one containing 250 mg levonorgestrel and 50 micrograms ethinyl estradiol and the other containing 150 micrograms desogestrel and 30 micrograms ethinyl estradiol, administered by the vaginal route were compared in 1055 women studied over 12,630 woman-months of vaginal contraceptive pill use. This multicenter clinical trial was performed in nine countries of the developing world by the "South to South Cooperation in Reproductive Health," an organization founded by scientists from the Third World working in the area of reproductive health, and the study was developed and coordinated by one of these centers. The findings of this study confirm the efficacy of both these tablets when administered by the vaginal route. Involuntary pregnancy rates at 1 year of 2.78 for subjects in the levonorgestrel group and 4.54 for subjects the desogestrel group showed no statistically significant difference between the two groups. However, total discontinuation rates of 47.01 for subjects in the levonorgestrel group and 56.33 for subjects in the desogestrel group showed a statistically significant difference between the two groups, and discontinuation rates attributable to prolonged bleeding of 0.6 for subjects in the levonorgestrel group and 3.2 for subjects in the desogestrel group were also significantly higher in the group of subjects using the desogestrel vaginal contraceptive pill. Blood pressure remained at admission values throughout treatment. A statistically significant weight increase from admission values occurred in both groups of subjects.
在1055名女性中进行了一项研究，她们使用阴道避孕药片的时间总计达12630妇女 - 月，比较了两种广泛使用的口服避孕药片经阴道给药的效果和可接受性。一种药片含有250毫克左炔诺孕酮和50微克炔雌醇，另一种含有150微克去氧孕烯和30微克炔雌醇。这项多中心临床试验由“生殖健康南南合作”组织在发展中世界的九个国家开展，该组织由在生殖健康领域工作的第三世界科学家创立，研究由其中一个中心开展并协调。这项研究的结果证实了这两种药片经阴道给药时的有效性。左炔诺孕酮组受试者1年时的意外怀孕率为2.78，去氧孕烯组受试者为4.54，两组之间无统计学显著差异。然而，左炔诺孕酮组受试者的总停药率为47.01，去氧孕烯组受试者为56.33，两组之间存在统计学显著差异，且使用去氧孕烯阴道避孕药片的受试者组中，因出血时间延长导致的停药率，左炔诺孕酮组为0.6，去氧孕烯组为3.2，去氧孕烯组也显著更高。整个治疗过程中血压维持在入院时的水平。两组受试者的体重均较入院时出现了统计学显著增加。
