Huber J
I. Universitäts-Frauenklinik, Wiener Universitäts, Vienna, Austria.
Int J Fertil. 1991;36 Suppl 1:25-31.
Research in the area of oral contraception currently focuses on the development of selective progestogens that combine targeted progestational and antiovulatory activity with a minimal potential for androgenicity. The present dual-center study was conducted to investigate the efficacy, tolerability, and safety of a new monophasic oral contraceptive (OC) containing 250 micrograms norgestimate in combination with 35 micrograms ethinyl estradiol (Ortho-Cyclen or Cilest). Ninety-seven healthy women of childbearing age participated in the study: 37 received the new norgestimate/ethinyl estradiol combination OC as primary therapy and 31 were switched over from other OCs. The norgestimate/ethinyl estradiol formulation was well tolerated and was associated with excellent cycle control. After six cycles of use, there were no statistically significant differences in the incidence of spotting or breakthrough bleeding compared with baseline, nor were there any significant changes in the incidence of headache, nausea, or mastalgia. Body weights remained constant for the duration of the study, as did systolic and diastolic blood pressures. Of particular note was the absence of any statistically significant alterations in metabolic parameters, including blood glucose or lipoprotein levels. These findings are consistent with the results of several other European studies and indicate that the norgestimate/ethinyl estradiol combination OC combines superior cycle control with minimal risk of androgenic side effects.
口服避孕药领域的研究目前聚焦于开发选择性孕激素，这类孕激素兼具靶向孕激素活性和抗排卵活性，同时雄激素化潜力极小。本双中心研究旨在调查一种新的单相口服避孕药（OC）的疗效、耐受性和安全性，该避孕药含有250微克诺孕酯和35微克炔雌醇（Ortho-Cyclen或Cilest）。97名育龄健康女性参与了该研究：37名接受新的诺孕酯/炔雌醇复方OC作为主要治疗，31名从其他OC转换而来。诺孕酯/炔雌醇制剂耐受性良好，且周期控制效果极佳。使用六个周期后，与基线相比，点滴出血或突破性出血的发生率无统计学显著差异，头痛、恶心或乳房疼痛的发生率也无显著变化。在研究期间，体重、收缩压和舒张压均保持恒定。特别值得注意的是，包括血糖或脂蛋白水平在内的代谢参数没有任何统计学显著改变。这些发现与其他几项欧洲研究的结果一致，表明诺孕酯/炔雌醇复方OC兼具卓越的周期控制和极小的雄激素副作用风险。
