Skouby S O
Department of Obstetrics and Gynecology, Herlev Hospital, Denmark.
Int J Fertil. 1987;32 Suppl:45-8.
The clinical effects of a low-dose triphasic oral contraceptive containing the new progestogen gestodene and ethinyl estradiol were investigated in phase II and III multicenter studies. The phase II study compared the clinical effects in 377 women taking this new compound during 2123 cycles with the effects of a low-dose triphasic combination of levonorgestrel and ethinyl estradiol in 362 women treated in 2088 cycles. The discontinuation rates after 6 months were similar in the two groups, and no major differences in side effects were observed. Cycle control was better during intake of the gestodene-containing preparation, since spotting occurred less frequently (P less than .05). The phase III investigation comprised 1921 women representing a total of 27,308 cycles. The Pearl index was 0.05. During the 24-month trial, 243 women (12.7%) dropped out of the study because of side effects, mainly bleeding disturbances (6.0%), headache (2.2%), and breast tension (2.0%). The results of these studies indicate that the triphasic combination of gestodene and ethinyl estradiol is well tolerated and provides high contraceptive efficacy and good cycle control.
在II期和III期多中心研究中，对含有新型孕激素孕二烯酮和炔雌醇的低剂量三相口服避孕药的临床效果进行了调查。II期研究比较了377名女性在2123个周期服用这种新化合物的临床效果与362名女性在2088个周期接受左炔诺孕酮和炔雌醇低剂量三相组合治疗的效果。两组6个月后的停药率相似，未观察到副作用有重大差异。服用含孕二烯酮制剂期间周期控制更好，因为点滴出血发生频率更低（P小于0.05）。III期调查包括1921名女性，共计27308个周期。Pearl指数为0.05。在24个月的试验期间，243名女性（12.7%）因副作用退出研究，主要是出血紊乱（6.0%）、头痛（2.2%）和乳房胀痛（2.0%）。这些研究结果表明，孕二烯酮和炔雌醇的三相组合耐受性良好，具有高避孕效果和良好的周期控制。
