Ospemifene in clinical practice for vulvo-vaginal atrophy: results at 3 months of follow-up of use

Abstract

Objective

To assess the effect of ospemifene 60 mg/day in vulvovaginal atrophy (VVA) in postmenopausal women under conditions of routine clinical practice after 3 months of follow-up.

Methods

The AYSEX study is a Spanish observational, prospective, and unicentric study in which 5 gynecologists recruited postmenopausal women with VVA in routine clinical practice treated with ospemifene 60 mg/day as an appropriate therapeutic option. Vaginal health, sexual health, dryness, dyspareunia, quality of life, and satisfaction with treatment were assessed at baseline and after three months using validated scales.

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, vaginal health index increased and vaginal pH, dryness, and dyspareunia decreased significantly (p < .0001). A significant improvement was observed in sexual function and quality of life.

Conclusions

This study in routine clinical practice conditions confirms the results previously reported by randomized controlled trials, including a significant improvement in VVA, sexual function, quality of life, and satisfaction with the treatment.

摘要

目的：通过3个月的随访观察, 在常规临床实践下, 观察口服奥培米芬60毫克/天治疗绝经后妇女外阴阴道萎缩（VVA）的疗效。

方法：AYSEX研究是一项西班牙的观察性、前瞻性和单中心研究, 其中5名妇科医生在常规临床实践中招募患有VVA的绝经后妇女, 以奥斯美芬60毫克/天作为适当的治疗选择。阴道健康、性健康、干涩、性交困难、生活质量和治疗满意度在治疗开始前和服药三个月后使用有效量表进行评估。

结果：共有100名绝经后女性经细胞学和临床诊断为VVA。使用奥斯美芬治疗3个月后, 阴道健康指数增加, 阴道pH值、干涩度和性交困难显著降低（p<0.0001）。性功能和生活质量明显改善。

结论：本研究在常规临床实践条件下证实了先前随机对照试验的结果, 包括VVA、性功能、生活质量和治疗满意度得到显著改善。

Keywords:

• Ospemifene
• dyspareunia
• dryness
• sexual function
• quality of life
• clinical practice

Acknowledgments

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

Ethical 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.

Antonio María Ierullo, Silvia Poyo Torcal, and Carlos Javier Maroto Díaz 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.