![Sample our Medicine, Dentistry, Nursing & Allied Health journals, sign in here to start your FREE access for 14 days]({"type":"image" , "src" : "/sda/5944/TOC-Subject-Sample-2021-Medicine-Dentistry-Nursing-Allied-Health.jpg"})
Abstract
Objective
To assess the improvement in vulvovaginal atrophy (VVA) of postmenopausal women treated with oral ospemifene 60 mg/day under conditions of routine clinical practice after 12 months of follow-up.
Methods
The AYSEX study is a Spanish observational, prospective, and unicentric study in which five gynecologists recruited postmenopausal women with VVA in routine clinical practice treated with oral ospemifene 60 mg/day as an appropriate therapeutic option. Vaginal health, the most bothersome symptoms, sexual health, endometrial safety, bone resorption markers, bone densitometry, mammography, treatment satisfaction, and quality of life were assessed at baseline and after 12 months using appropriate 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, a significant improvement was observed in all domains of Vaginal Health Index. This improvement was maintained at month 12 and only one patient remained with vaginal atrophy. In addition, a significant improvement was observed in the most bothersome symptoms, sexual function, and quality of life. There was no significant change in endometrial thickness, mammography, and bone health during the 12 months of treatment.
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, endometrial safety, and satisfaction with the treatment.
摘要
目的：观察绝经后妇女在常规临床治疗条件下口服奥培米芬 60 mg/d对外阴阴道萎缩(VVA)的改善情况, 随访12个月。
方法:AYSEX研究是一项西班牙的观察性、前瞻性和单中心研究, 5名妇科医生招募了患有VVA的绝经后妇女, 在常规临床实践中口服奥培米芬 60mg/d作为适当的治疗选择。使用适当的量表在基线和12个月后评估阴道健康、最麻烦的症状、性健康、子宫内膜安全、骨吸收标志物、骨密度测量、乳房x线摄影、治疗满意度和生活质量。
结果:共纳入100例经细胞学和临床诊断为VVA的绝经后妇女。应用奥培米芬治疗3个月后, 阴道健康指数各方面均有明显改善。这种改善在12个月时得到维持, 只有1例患者仍有阴道萎缩。此外, 在最困扰的症状、性功能和生活质量方面也观察到了显著的改善。在治疗的12个月期间, 子宫内膜厚度、乳房x光检查和骨骼健康没有显著变化。
结论:本研究在常规临床实践条件下证实了此前随机对照试验报道的结果, 包括VVA、性功能、生活质量、子宫内膜安全性和治疗满意度显著改善。
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. 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. María del Carmen Guitiérrez Vélez has not conflict of interests. Virginia Calvente Aguilar has not conflict of interests. Silvia Poyo Torcal has not conflict of interests. Pablo Terol Sánchez has not conflict of interests. 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. No potential conflict of interest was reported by the author(s).