Use of an estradiol transdermal spray in women with menopausal symptoms: a non-interventional study.

IF 2.9 4区医学 Q1 OBSTETRICS & GYNECOLOGY Climacteric Pub Date : 2024-07-22 DOI:10.1080/13697137.2024.2376185

Peyman Hadji, Jens-Olaf Schmeißer, Klaus Peters, Erwin Göckeler-Leopold

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Abstract

Objective: This study aimed to investigate the effectiveness, tolerability and application of estradiol metered-dose transdermal spray (EMDTS) in postmenopausal women during real-world use.

Methods: This was a prospective, non-interventional, multicenter, observational phase IV cohort study. The Menopause Rating Scale II (MRS II) was used to assess symptoms and clinical response. Safety was assessed by the occurrence of adverse events and adverse drug reactions (ADRs).

Results: A total of 451 postmenopausal women were enrolled at 52 gynecological practices across Germany; 383 patients were evaluated for effectiveness and 430 patients for safety. Mean age was 54.3 ± 7.4 years. In total, 228 patients (59.5%) received EMDTS monotherapy and 155 patients (40.5%) received EMDTS plus progestogens. Significant improvements (p < 0.0001) from baseline in symptom severity were recorded for all 11 items of the MRS II at 3, 6 and 12 months of treatment. At 12 months, 81.4% of patients reported improvement in hot flushes/sweating. At final visit, 73% of patients and 77% of physicians were 'satisfied/very pleased' with EMDTS. Most common ADRs were headache (n = 6), nausea (n = 4), dizziness (n = 4) and pruritus (n = 3).

Conclusions: EMDTS is an effective, well tolerated and easily applied hormone replacement therapy for women experiencing postmenopausal symptoms.

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在有更年期症状的妇女中使用雌二醇透皮喷雾剂：一项非干预性研究。

目的本研究旨在调查雌二醇计量透皮喷雾剂（EMDTS）在绝经后妇女实际使用过程中的有效性、耐受性和应用情况：这是一项前瞻性、非干预性、多中心、观察性的 IV 期队列研究。更年期评定量表 II（MRS II）用于评估症状和临床反应。安全性通过不良事件和药物不良反应（ADRs）的发生率进行评估：德国 52 家妇科诊所共招募了 451 名绝经后妇女，其中 383 名患者接受了有效性评估，430 名患者接受了安全性评估。平均年龄为 54.3 ± 7.4 岁。共有228名患者（59.5%）接受了EMDTS单药治疗，155名患者（40.5%）接受了EMDTS加孕激素治疗。结论：EMDTS是一种有效且效果显著的治疗方法，其疗效显著（p n = 6）、恶心（n = 4）、头晕（n = 4）和瘙痒（n = 3）：EMDTS是一种有效、耐受性好且易于应用的激素替代疗法，适用于出现绝经后症状的妇女。

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.