Department of Obstetrics and Gynecology, University of Washington, Seattle, Washington, 98195-6460, USA.
Adv Ther. 2013 Jan;30(1):1-13. doi: 10.1007/s12325-012-0071-3. Epub 2012 Dec 12.
The new estradiol valerate and dienogest oral contraceptive pill recently received U.S. Food and Drug Administration (FDA) approval to treat heavy menstrual bleeding in women without diagnosed uterine conditions.This oral contraceptive formulation combines estradiol valerate, which is metabolically identical to natural estradiol, with the potent new progestin, dienogest. The four-phasic pill is effective for pregnancy prevention and leads to significantly decreased menstrual bleeding among women with heavy periods, and shorter and lighter periods among women with normal periods. Studies indicate that this formulation may be associated with decreased hepatic activation compared to contraceptive pills that contain ethinyl estradiol. However, whether these findings translate to a decreased risk of thrombotic events has not been determined, and the pill carries the same contraindications as all other combined hormonal contraceptives.At least 10-15% of women suffer from heavy menstrual bleeding, defined as ≥80 mL of blood loss per cycle. In large clinical trials of women with heavy menstrual bleeding, the estradiol valerate and dienogest pill decreased blood loss volume by a median of 81%.Women with heavy menstrual bleeding treated with this contraceptive pill can expect a significant reduction in bleeding after just one cycle of use. This therapy leads to a decrease in bleeding that may be greater than that achieved by different oral contraceptive pills or other medical therapies, including tranexamic acid and nonsteroidal anti-inflammatory drugs.
最近，戊酸雌二醇和地诺孕素的新型口服避孕药获得了美国食品和药物管理局（FDA）的批准，可用于治疗无子宫疾病的女性的月经过多。这种口服避孕药配方将戊酸雌二醇（其代谢物与天然雌二醇相同）与新型强效孕激素地诺孕素结合在一起。这种四相避孕药可有效避孕，可显著减少月经过多女性的月经出血，也可减少正常经期女性的经期出血天数和出血量。研究表明，与含有炔雌醇的避孕药相比，这种配方可能与肝活化减少有关。然而，这些发现是否转化为血栓形成事件风险降低，尚未确定，并且该避孕药与所有其他联合激素避孕药一样存在禁忌症。至少有 10-15%的女性患有月经过多，定义为每周期失血≥80 毫升。在患有月经过多的女性的大型临床试验中，戊酸雌二醇和地诺孕素避孕药使失血量中位数减少了 81%。接受这种避孕药治疗的月经过多女性仅使用一个周期后即可预期出血量明显减少。这种治疗方法可导致出血量减少，可能大于不同口服避孕药或其他医学疗法（包括氨甲环酸和非甾体抗炎药）的治疗效果。
