Mansour Diana, Verhoeven Carole, Sommer Werner, Weisberg Edith, Taneepanichskul Surasak, Melis Gian Benedetto, Sundström-Poromaa Inger, Korver Tjeerd
Sexual Health Services, Newcastle Hospitals Community Health, Newcastle upon Tyne, UK.
Eur J Contracept Reprod Health Care. 2011 Dec;16(6):430-43. doi: 10.3109/13625187.2011.614029. Epub 2011 Oct 13.
The primary objective was to assess the efficacy, cycle control and tolerability of a monophasic combined oral contraceptive (COC) containing nomegestrol acetate (NOMAC) and 17β-oestradiol (E2). Effects on acne were evaluated as a secondary objective. Results were compared to those of a COC containing drospirenone (DRSP) and ethinylestradiol (EE).
Women (aged 18-50 years) were randomised to receive NOMAC/E2 (2.5 mg/1.5 mg) in a 24/4-day regimen (n=1591) or DRSP/EE (3 mg/30 μg) in a 21/7-day regimen (n=535) for 13 cycles.
Estimated Pearl Indices for NOMAC/E2 and DRSP/EE were 0.38 and 0.81 in women aged≤35 years and 0.31 and 0.66 for all women (18-50 years), respectively. Scheduled withdrawal bleedings were shorter and lighter among users of NOMAC/E2 and were sometimes absent altogether. Intracyclic bleeding/spotting was infrequent in both groups, and decreased over time. Type and frequency of adverse events were similar to those typically reported for COCs.
These data show that NOMAC/E2 provides high contraceptive efficacy with acceptable cycle control as well as an overall adverse event profile similar to that of DRSP/EE.
主要目的是评估含有醋酸诺美孕酮（NOMAC）和17β - 雌二醇（E2）的单相复方口服避孕药（COC）的疗效、周期控制和耐受性。将对痤疮的影响作为次要目的进行评估。将结果与含有屈螺酮（DRSP）和炔雌醇（EE）的COC的结果进行比较。
将年龄在18 - 50岁的女性随机分为两组，一组接受24/4天给药方案的NOMAC/E2（2.5毫克/1.5毫克）（n = 1591），另一组接受21/7天给药方案的DRSP/EE（3毫克/30微克）（n = 535），共治疗13个周期。
年龄≤35岁的女性中，NOMAC/E2和DRSP/EE的估计 Pearl 指数分别为0.38和0.81；所有女性（18 - 50岁）中，这两个指数分别为0.31和0.66。NOMAC/E2使用者的计划性撤药性出血更短、更轻，有时甚至完全没有。两组的周期内出血/点滴出血情况均不常见，且随时间减少。不良事件的类型和频率与COC通常报告的相似。
这些数据表明，NOMAC/E2具有高避孕效果，周期控制良好，总体不良事件情况与DRSP/EE相似。
