Low thrombin generation in postmenopausal women using estetrol.

IF 2.9 4区医学 Q1 OBSTETRICS & GYNECOLOGY Climacteric Pub Date : 2024-04-01 Epub Date: 2024-01-19 DOI:10.1080/13697137.2023.2292066

L Morimont, M Didembourg, C Bouvy, M Jost, M Taziaux, Y Oligschlager, M van Rooijen, U Gaspard, J-M Foidart, J Douxfils

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Abstract

Objective: Estetrol (E4) represents a novel estrogen of interest to relieve vasomotor symptoms. E4 activates the nuclear estrogen receptor α (ERα) but antagonizes the estradiol ERα-dependent membrane-initiated steroid signaling pathway. The distinct pharmacological properties of E4 could explain its low impact on hemostasis. This study aimed to assess the effect of E4 on coagulation in postmenopausal women, using the thrombin generation assay (TGA).

Methods: Data were collected from a multicenter, randomized, placebo-controlled, dose-finding study in postmenopausal women (NCT02834312). Oral E4 (2.5 mg, n = 42; 5 mg, n = 29; 10 mg, n = 34; or 15 mg, n = 32) or placebo (n = 31) was administered daily for 12 weeks. Thrombograms and TGA parameters were extracted for each subject at baseline and after 12 weeks of treatment.

Results: After 12 weeks of treatment, all treatment groups showed a mean thrombogram (±95% confidence interval [CI] of the mean) within the reference ranges, that is, the 2.5th-97.5th percentile of all baseline thrombograms (n = 168), as well as for TGA parameters.

Conclusions: The intake of E4 15 mg for 12 weeks led to significant but not clinically relevant changes compared to baseline as the mean values (±95% CI of the mean) remained within reference ranges, demonstrating a neutral profile of this estrogen on hemostasis.

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使用雌酮的绝经后妇女凝血酶生成量低。

目的：雌二醇（E4）是一种新型雌激素，可缓解血管运动症状。E4能激活核雌激素受体α（ERα），但却能拮抗雌二醇ERα依赖膜引发的类固醇信号通路。E4独特的药理特性可能是其对止血影响较小的原因。本研究旨在使用凝血酶生成试验（TGA）评估 E4 对绝经后妇女凝血功能的影响：数据来自一项针对绝经后妇女的多中心、随机、安慰剂对照、剂量调查研究（NCT02834312）。每天口服 E4（2.5 毫克，42 人；5 毫克，29 人；10 毫克，34 人；或 15 毫克，32 人）或安慰剂（31 人），为期 12 周。提取每个受试者在基线和治疗 12 周后的血栓图和 TGA 参数：治疗 12 周后，所有治疗组的平均血栓图（±95% 置信区间 [CI]）均在参考范围内，即所有基线血栓图的 2.5-97.5 百分位数（n = 168），TGA 参数也在参考范围内：结论：与基线值相比，连续 12 周服用 15 毫克 E4 会导致显著但无临床意义的变化，因为平均值（平均值的±95% CI）仍在参考范围内，这表明这种雌激素对止血的影响是中性的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Climacteric 医学-妇产科学

CiteScore

1.70

自引率

7.10%

发文量

审稿时长

1 months

期刊介绍： Climacteric is the official journal of the International Menopause Society (IMS). As an international peer-reviewed journal it publishes original research and reviews of all aspects of aging in women. Climacteric was founded by the IMS in 1998 and today has become a leading journal in the publication of peer-reviewed papers on the menopause, climacteric and mid-life health. Topics covered include endocrine changes, symptoms attributed to the menopause and their treatment, hormone replacement and alternative therapies, lifestyles, and the counselling and education of peri- and postmenopausal women. Climacteric, published bimonthly, also features regular invited reviews, editorials and commentaries on recent developments. The editorial review board of Climacteric includes leading scientific and clinical experts in the field of midlife medicine and research and is headed by its Editor-in-Chief, Professor Rod Baber of Australia. He and his team of Associate Editors act independently to set a clear editorial policy, co-ordinate peer review, and ensure a rapid response to submitted papers.