de Andrade R P
Hospital de Clinicas de U.F.P. Curitiba, Brazil.
Int J Fertil. 1989 Sep;34 Suppl:22-30.
The safety and efficacy of a low-dose monophasic oral contraceptive (OC) containing a new progestogen, gestodene (GTD), combined with ethinyl estradiol (EE) is being investigated in two ongoing multicenter trails. In this interim analysis, the formulation was found to be effective and well tolerated. Subject compliance was excellent; no pills were missed in 91.2% of the cycles. The number of women who withdrew from the study was low (15%), indicating good subject acceptance. GTD + EE provided optimal cycle control. Of the total number of OC cycles analyzed, spotting occurred in 8.1%, breakthrough bleeding in 1.8%, and both spotting and breakthrough bleeding in 3.3%. The incidence of spotting decreased fairly steadily during OC administration. Amenorrhea occurred in 0.5% of the cycles. There were no unexpected or serious side effects. The incidence of side effects was low and declined with increased duration of OC use. There were no clinically significant changes in weight or blood pressure. Virtually all of the systolic and diastolic blood pressure readings were in the normal range. The results of this interim analysis indicate that the GTD + EE formulation is a safe and reliable contraceptive.
一种含有新型孕激素孕二烯酮（GTD）与炔雌醇（EE）的低剂量单相口服避孕药（OC）的安全性和有效性正在两项正在进行的多中心试验中进行研究。在这项中期分析中，该制剂被发现是有效的且耐受性良好。受试者的依从性极佳；在91.2%的周期中没有漏服药物。退出研究的女性人数较少（15%），表明受试者接受度良好。GTD + EE提供了最佳的周期控制。在分析的OC周期总数中，点滴出血发生率为8.1%，突破性出血发生率为1.8%，点滴出血和突破性出血均有的发生率为3.3%。在服用OC期间，点滴出血的发生率相当稳定地下降。闭经发生率为0.5%。没有出现意外或严重的副作用。副作用发生率较低，且随着OC使用时间的延长而下降。体重和血压没有临床上的显著变化。几乎所有的收缩压和舒张压读数都在正常范围内。这项中期分析的结果表明，GTD + EE制剂是一种安全可靠的避孕药。
