Rabe T, Runnebaum B, Kohlmeier M, Harenberg J, Weicker H
Department of Obstetrics and Gynaecology, University of Heidelberg, West Germany.
Int J Fertil. 1987;32 Suppl:29-44.
The new low-dose combination oral contraceptive (OC) containing 75 micrograms of the new progestogen gestodene (GTD) plus 30 micrograms ethinyl estradiol (EE) was clinically tested and compared with a levonorgestrel (LNG) combined pill (150 micrograms LNG plus 30 micrograms EE). In a randomized clinical comparative study (A), 176 women were treated with the GTD-containing pill and 185 with the LNG-containing pill for six cycles. This study was followed by a second multicenter study (B) covering 707 patients taking the GTD-containing pill for up to 24 cycles (total, 9,947 cycles). In a third study (C), metabolic effects were assessed using a randomly organized baseline control trial (pretreatment/treatment cycles); 30 patients received the GTD-containing pill and 30 received the LNG-containing pill. Carbohydrate metabolism, lipid metabolism, and blood clotting were investigated, and an interim analysis was performed after six OC cycles. No pregnancies and no severe side effects occurred in any of the studies. Intermenstrual bleeding decreased as usual during treatment. In the total number of gestodene cycles in studies A and B, there was a 6.9% incidence of spotting, a 0.8% incidence of breakthrough bleeding, and a 0.7% incidence of both spotting and breakthrough bleeding in studies A and B patients taking gestodene. Amenorrhea occurred in 0.6% of cycles. Body weight remained unchanged (+/- 2 kg) after 24 cycles in 80.5% of study B patients taking gestodene. Blood pressure remained normal in about 95% of all study B patients; a normalization was observed in greater than 60% of patients with previously elevated blood pressure. No clinically relevant changes in carbohydrate metabolism, lipid metabolism, or blood clotting were observed in study C. The new GTD-containing low-dose combination pill proved to be a safe and reliable contraceptive agent.
含有75微克新型孕激素孕二烯酮（GTD）加30微克炔雌醇（EE）的新型低剂量复方口服避孕药（OC）进行了临床试验，并与左炔诺孕酮（LNG）复方片剂（150微克LNG加30微克EE）进行了比较。在一项随机临床对照研究（A）中，176名妇女服用含GTD的片剂，185名妇女服用含LNG的片剂，为期六个周期。该研究之后是第二项多中心研究（B），涵盖707名服用含GTD片剂长达24个周期（共9947个周期）的患者。在第三项研究（C）中，使用随机组织的基线对照试验（治疗前/治疗周期）评估代谢效应；30名患者服用含GTD的片剂，30名患者服用含LNG的片剂。研究了碳水化合物代谢、脂质代谢和血液凝固情况，并在六个口服避孕药周期后进行了中期分析。所有研究中均未发生妊娠和严重副作用。治疗期间，经间出血如往常一样减少。在研究A和B中服用孕二烯酮的患者的孕二烯酮周期总数中，点滴出血发生率为6.9%，突破性出血发生率为0.8%，点滴出血和突破性出血发生率均为0.7%。闭经发生率为0.6%。在研究B中，80.5%服用孕二烯酮的患者在24个周期后体重保持不变（±2千克）。在所有研究B患者中，约95%的血压保持正常；在先前血压升高的患者中，超过60%的患者血压恢复正常。在研究C中，未观察到碳水化合物代谢、脂质代谢或血液凝固方面有临床相关变化。新型含GTD低剂量复方片剂被证明是一种安全可靠的避孕药。
