The aim of this study was to compare contraceptive reliability, cycle control and tolerance of an oral contraceptive containing 20 micrograms ethinylestradiol and 75 micrograms gestodene, with a reference preparation containing the same dose of estrogen combined with 150 micrograms desogestrel. This article presents interim data from centers in France and Austria, involving a total of 479 women and 4,991 cycles. Contraceptive reliability was good with both preparations. Two pregnancies occurred in the gestodene group, but neither were due to method failure. In the desogestrel group there were also two pregnancies, of which one was due to method failure. With respect to cycle control, there is a trend towards a lower incidence of intermenstrual bleeding in the gestodene group. The incidence of spotting (scanty bleeding) during the important first three cycles was 3.5% lower in the gestodene group, and over the first six cycles, it was 7.6% lower. Amenorrhea was similar in both groups, but the incidence of dysmenorrhea was significantly lower in the gestodene group (p=0.001). Adverse events were similar in both groups, with headache, breast tension and nausea the most frequently reported symptoms. Body weight remained relatively constant during treatment in both groups, and no hypertension was reported for any woman during the course of the study. In each treatment group, 19 women discontinued because of adverse events. It is concluded that both preparation are reliable and well tolerated oral contraceptives are reliable and well tolerated oral contraceptives; however, there is a more favourable effect on dysmenorrhea by the gestodene formulation.

译文

这项研究的目的是比较口服避孕药的避孕可靠性,周期控制和耐受性,口服避孕药中含有20毫克乙炔雌二醇和75毫克孕二烯酮,而参比制剂中含有相同剂量的雌激素和150毫克地索孕酮。本文介绍了来自法国和奥地利的中心的临时数据,涉及总共479名妇女和4,991个周期。两种制剂的避孕可靠性均良好。孕二烯酮组发生了两次怀孕,但都不是由于方法失败而引起的。在去氧孕烯组中也有两次怀孕,其中一次是由于方法失败而引起的。关于周期控制,孕二烯酮组月经间出血的发生率有降低的趋势。孕二烯酮组在重要的前三个周期中出现斑点(少量出血)的发生率降低了3.5%,而在前六个周期中,则降低了7.6%。两组的闭经情况相似,但孕二烯酮组的痛经发生率显着降低(p = 0.001)。两组的不良事件相似,头痛,乳房紧张和恶心是最常报告的症状。两组患者在治疗期间体重均保持相对恒定,并且在研究过程中未见任何女性患有高血压。在每个治疗组中,有19名妇女因不良事件而停药。结论是,两种制剂都是可靠且耐受性良好的口服避孕药;是可靠且耐受性良好的口服避孕药。但是,孕二烯酮制剂对痛经有更有利的作用。

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