Instituto Palacios de Salud y Medicina de la Mujer, Madrid, Spain.
Eur J Obstet Gynecol Reprod Biol. 2010 Mar;149(1):57-62. doi: 10.1016/j.ejogrb.2009.11.001. Epub 2009 Dec 6.
A novel oral contraceptive (OC) that contains oestradiol valerate (E2V; 1 mg of E2V is equivalent to 0.76 mg of 17beta-oestradiol) and dienogest (DNG) has been developed. The efficacy and safety of this formulation was assessed in the current study.
This was a multicentre, open-label, non-comparative, 20-cycle study conducted in Germany, Austria and Spain in healthy women aged 18-50 years. E2V/DNG was administered using an oestrogen step-down and a progestin step-up approach over 26 days (E2V 3 mg on days 1 and 2, E2V 2 mg/DNG 2 mg on days 3-7, E2V 2 mg/DNG 3 mg on days 8-24, E2V 1 mg on days 25 and 26 and placebo on days 27 and 28). The primary outcome measure was the number of pregnancies during treatment in the whole study population and in the subgroup of women aged 18-35 years. Contraceptive efficacy was estimated by calculating the Pearl Index (number of pregnancies per 100 women-years of exposure). At a final examination, treatment satisfaction was assessed.
In total, 1377 women received study treatment. During the study, thirteen pregnancies occurred (unadjusted Pearl Index: 0.73). Six of these were due to method failure (adjusted Pearl Index: 0.34). In the subgroup of 998 women aged 18-35 years, 12 pregnancies occurred (unadjusted Pearl Index: 0.94), five of which were due to method failure (adjusted Pearl Index: 0.40). The majority of women (79.5%) were satisfied or very satisfied with treatment. Treatment-related adverse events (considered at least possibly treatment-related) occurred in 19.8% of women. Overall, during 20 cycles of treatment, only 10.2% of women prematurely discontinued treatment due to an adverse event.
A novel OC based on oestradiol provides highly effective and reliable contraception. This is achieved through the combination of oestradiol valerate (E2V) and dienogest (DNG) administered using an oestrogen step-down and a progestin step-up approach over 26 days of active treatment followed by 2 days of placebo. The preparation is well tolerated and is associated with a high degree of user satisfaction and a low discontinuation rate.
开发了一种新型口服避孕药（OC），其中包含雌二醇戊酸酯（E2V；1 毫克 E2V 相当于 0.76 毫克 17β-雌二醇）和地诺孕素（DNG）。本研究评估了该配方的疗效和安全性。
这是一项在德国、奥地利和西班牙进行的多中心、开放标签、非对照、20 个周期的研究，纳入年龄在 18-50 岁的健康女性。E2V/DNG 通过雌激素逐步减少和孕激素逐步增加的方法给药，共 26 天（第 1 和第 2 天给予 E2V 3 毫克，第 3-7 天给予 E2V 2 毫克/DNG 2 毫克，第 8-24 天给予 E2V 2 毫克/DNG 3 毫克，第 25 和第 26 天给予 E2V 1 毫克，第 27 和第 28 天给予安慰剂）。主要结局指标是在整个研究人群和年龄在 18-35 岁的女性亚组中治疗期间的妊娠数。避孕效果通过计算 Pearl 指数（每 100 名女性-年暴露的妊娠数）来估计。在最后一次检查时，评估了治疗满意度。
共有 1377 名女性接受了研究治疗。研究期间发生了 13 例妊娠（未调整 Pearl 指数：0.73）。其中 6 例归因于方法失败（调整 Pearl 指数：0.34）。在 998 名年龄在 18-35 岁的女性亚组中，发生了 12 例妊娠（未调整 Pearl 指数：0.94），其中 5 例归因于方法失败（调整 Pearl 指数：0.40）。大多数女性（79.5%）对治疗满意或非常满意。19.8%的女性出现了与治疗相关的不良事件（至少可能与治疗相关）。总体而言，在 20 个周期的治疗中，只有 10.2%的女性因不良事件提前终止治疗。
基于雌二醇的新型 OC 提供了高度有效和可靠的避孕效果。这是通过雌二醇戊酸酯（E2V）和地诺孕素（DNG）联合使用实现的，在 26 天的活性治疗后，采用雌激素逐步减少和孕激素逐步增加的方法，然后给予 2 天安慰剂。该制剂耐受性良好，与高度的用户满意度和低停药率相关。
