Vaginal health, endometrial thickness and changes in bone markers in postmenopausal women after 6 months of treatment with ospemifene in real clinical practice

Abstract

Objective

To assess vaginal health, endometrial thickness, and changes in bone markers in postmenopausal women with vulvovaginal atrophy (VVA) treated with 60 mg/day of ospemifene under routine clinical practice.

Methods

The AYSEX study is a Spanish observational and prospective study performed in one center in which 5 gynecologists recruited postmenopausal women with VVA in routine clinical practice treated continuously with ospemifene 60 mg/day for 12 months as an appropriate therapeutic option. This article refers to the 3- and 6-months analysis. Vaginal health was assessed by pH and using Vaginal Health Index (VHI) at baseline and 3 months later. Endometrial thickness, measured by vaginal ultrasonography, and bone resorption marker (CTx) were assessed at baseline and 6 months later.

Results

A total of 100 postmenopausal women cytologically and clinically diagnosed with VVA were included in the study. After 3 months of treatment with ospemifene, pH improved from 6.1 to 4.5 (p < .0001), and VHI improved from 10 to 19 points (p < .0001). The percentage of patients with VVA according to VHI decreased from 100% to 5.2% (p < .0001). After 6 months, mean CTx levels decreased from 0.42 pg/ml at baseline to 0.37 pg/ml 6 months later (p = .0018), and mean endometrial thickness changed from 2.24 to 2.15 mm (p = .6066).

Conclusions

Up to date, this is the only prospective and observational study with ospemifene in routine clinical practice conditions and confirms the results previously reported from randomized controlled clinical trials, improving VVA, not increasing endometrial thickness, and decreasing CTx levels by exerting an anti-resorptive function.

绝经后女性常规应用奥培米芬治疗6个月后阴道健康、子宫内膜厚度和骨吸收标志物变化 摘要

目的：评估绝经后外阴萎缩（VVA）的女性临床常规应用60mg/天的奥培米芬治疗的阴道健康、子宫内膜厚度和骨吸收标志物的变化。

方法：AYSEX研究是一项西班牙单中心观察性和前瞻性研究, 5名妇科医生招募了绝经后外阴萎缩（VVA）临床常规连续应用奥培米芬60mg/天治疗12个月作为治疗的女性。本文显示治疗3个月和6个月的分析结果。通过pH值和使用阴道健康指数（VHI）来评估基线和治疗3个月后阴道健康情况。通过阴道超声检查检测基线和治疗6个月后子宫内膜厚度情况, 并评估骨吸收标志物（CTx）。

结果：研究共纳入100名经细胞学和临床诊断为VVA的绝经后女性。研究显示应用奥培米芬治疗3个月后, 阴道pH值从6.1改善到4.5 (p <.0001), 而VHI从10分改善到19分(p < .0001)。根据VHI, VVA患者的百分比从100%下降到5.2%（p <.0001）。6个月后, 平均CTx水平下降, 从基线的0.42 pg/ml降至治疗6个月后的0.37 pg/ml（p = .0018）, 平均子宫内膜厚度从2.24mm降至2.15mm（p = .6066）。

结论：目前这是唯一一项在常规临床实践条件下应用奥培米芬的前瞻性和观察性研究。证实了以前随机对照临床试验的结果, 改善了VVA, 不增加子宫内膜厚度, 并通过发挥抗吸收功能降低CTx水平

Keywords:

• Ospemifene
• vulvovaginal atrophy
• endometrial thickness
• bone resorption marker
• bone mineral density

Acknowledgments

The author would like to thank Fernando Sánchez Barbero Ph.D. for providing medical writing assistance.

Ethics approval

The study was conducted in accordance with the Declaration of Helsinki and current Good Clinical Practice guidelines, and was approved by the Research Ethics Committee of Fundación Jiménez Díaz (Madrid, Spain) and the Department of Heath of Madrid of Comunidad de Madrid. Written informed consent was provided by all participants before initiating the study. National legislation on data protection was applied (Organic Law 15/1999, of 13 December, on the Protection of Personal Data). Documents containing patients' personal information were encrypted. Only authorized personnel had access to them.

Disclosure statement

Carmen Pingarrón has been a symposium speaker and advisory board member for Pfizer, Shionogi, Theramex. MSD, Exeltis, Faes, and Iprad. She has also received research grants and/or consulting fees from Pfizer, MSD, Theramex, Shionogi, Effik, Exeltis, Faes, Iprad, and NTDs labs. Pilar Lafuente González has been a symposium speaker and advisory board member for Sanofi-Genzyme, Biogen, Bayer, Italfarmaco, Shionogi, MSD, Effick and Uriach. Silvia Poyo Torcal, Helena López Verdú, and María Sol Martínez García have no potential conflict of interest. Santiago Palacios has been a symposium speaker and advisory board member for Pfizer, Procare heath, Lacer, Abbott, Novo Nordisk, Serelys, Procaps, Tecnofarma, Shionogi, and Amgen. He has also received research grants and/or consulting fees from Pfizer, Amgen, MSD, Novo Nordisk, Exeltis, Gynea, and Sandoz.

Additional information

Funding

This study has been funded through an unrestricted medical research grant provided by Shionogi.