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基于雌二醇的复方口服避孕药的垂体、卵巢和额外避孕效果:一项随机、开放标签研究的结果。

Pituitary, ovarian and additional contraceptive effects of an estradiol-based combined oral contraceptive: results of a randomized, open-label study.

机构信息

Bayer HealthCare Pharmaceuticals, 13353 Berlin, Germany.

出版信息

Contraception. 2013 Feb;87(2):227-34. doi: 10.1016/j.contraception.2012.07.008. Epub 2012 Sep 17.

DOI:10.1016/j.contraception.2012.07.008
PMID:22995539
Abstract

BACKGROUND

The estrogen step-down/progestogen step-up 28-day estradiol valerate/dienogest (E(2)V/DNG) oral contraceptive effectively inhibits ovulation; however, limited data are available regarding its effects on estradiol (E2), progesterone, luteinizing hormone (LH) and follicle-stimulating hormone (FSH) or its additional extraovarian contraceptive effects.

STUDY DESIGN

In this secondary analysis, 100 women received E(2)V 3 mg on days 1-2, E(2)V 2 mg/DNG 2 mg on days 3-7, E(2)V 2 mg/DNG 3 mg on days 8-24, E(2)V 1 mg on days 25-26 and placebo on days 27-28 for one treatment cycle. Measures included the presence/absence of cervical mucus; endometrial thickness; and serum E2, progesterone, and gonadotropin levels.

RESULTS

E2, progesterone, LH and FSH levels did not exhibit the typical ovulatory increase and remained relatively stable during the cycle. E(2)V/DNG reduced mean maximal endometrial thickness and proportion of women with visible cervical mucus. All parameters returned to pretreatment levels during the posttreatment cycle.

CONCLUSION

E(2)V/DNG provides extraovarian contraceptive effects (reducing endometrial thickness and cervical mucus production) in addition to inhibiting ovulation, assuring contraceptive efficacy.

摘要

背景

雌二醇递减/孕二烯酮递增 28 天戊酸雌二醇/地诺孕素(E(2)V/DNG)口服避孕药能有效抑制排卵;然而,关于其对雌二醇(E2)、孕酮、促黄体生成素(LH)和卵泡刺激素(FSH)的影响,以及其额外的卵巢外避孕作用,数据有限。

研究设计

在这项二次分析中,100 名女性接受了一个治疗周期的治疗,第 1-2 天服用 3mgE(2)V,第 3-7 天服用 2mgE(2)V/2mgDNG,第 8-24 天服用 2mgE(2)V/3mgDNG,第 25-26 天服用 1mgE(2)V,第 27-28 天服用安慰剂。测量包括宫颈黏液的存在/缺失;子宫内膜厚度;以及血清 E2、孕酮和促性腺激素水平。

结果

E2、孕酮、LH 和 FSH 水平没有出现典型的排卵增加,在整个周期中相对稳定。E(2)V/DNG 降低了平均最大子宫内膜厚度和有可见宫颈黏液的女性比例。所有参数在治疗后周期中均恢复到治疗前水平。

结论

E(2)V/DNG 除了抑制排卵外,还提供卵巢外避孕作用(减少子宫内膜厚度和宫颈黏液的产生),确保避孕效果。

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