Safety and efficacy of ospemifene for the treatment of dyspareunia associated with vulvar and vaginal atrophy due to menopause

Gregory T Wurz, Chiao-Jung Kao, Michael W DeGregorio Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis, Sacramento, CA, USA Abstract: During the menopausal transition, women experience a number of symptoms due to declining estrogen levels, includin...

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Autores principales:	Wurz GT, Kao CJ, DeGregorio MW
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2014
Materias:	Ospemifene SERM Dyspareunia Vaginal Dryness Vulvar and Vaginal Atrophy Geriatrics RC952-954.6
Acceso en línea:	https://doaj.org/article/83b025405eab4bb59a699d7f34d71146
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spelling	oai:doaj.org-article:83b025405eab4bb59a699d7f34d711462021-12-02T06:20:40ZSafety and efficacy of ospemifene for the treatment of dyspareunia associated with vulvar and vaginal atrophy due to menopause1178-1998https://doaj.org/article/83b025405eab4bb59a699d7f34d711462014-11-01T00:00:00Zhttps://www.dovepress.com/safety-and-efficacy-of-ospemifene-for-the-treatment-of-dyspareunia-ass-peer-reviewed-article-CIAhttps://doaj.org/toc/1178-1998Gregory T Wurz, Chiao-Jung Kao, Michael W DeGregorio Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis, Sacramento, CA, USA Abstract: During the menopausal transition, women experience a number of symptoms due to declining estrogen levels, including vasomotor symptoms and vulvar and vaginal atrophy (VVA). Unlike vasomotor symptoms, vaginal dryness and dyspareunia, the main symptoms of VVA, typically worsen without treatment and can significantly impact the quality of life. Up to 60% of postmenopausal women may be affected by VVA, but many women unfortunately do not seek treatment due to embarrassment or other factors. After 20+ years in development, ospemifene (Osphena™) was approved by the US Food and Drug Administration in 2013 for treatment of moderate-to-severe dyspareunia associated with VVA due to menopause. As the first non-hormonal alternative to estrogen-based products for this indication, the approval of ospemifene represents a significant milestone in postmenopausal women’s health. Ospemifene is a non-steroidal estrogen receptor agonist/antagonist, also known as a selective estrogen receptor modulator (SERM), from the same chemical class as the breast cancer drugs tamoxifen and toremifene. Unlike other selective estrogen receptor modulators, ospemifene exerts a strong, nearly full estrogen agonist effect in the vaginal epithelium, making it well suited for the treatment of dyspareunia in postmenopausal women. Results of Phase III clinical trials showed that ospemifene significantly improved the vaginal maturation index (decreased parabasal cells and increased superficial cells), decreased vaginal pH, and decreased severity of the self-identified most bothersome symptom (dyspareunia or vaginal dryness) compared to placebo. Long-term safety studies revealed that 60 mg ospemifene given daily for 52 weeks was well tolerated and was not associated with any endometrium or breast-related safety concerns. This review discusses the preclinical and clinical data supporting the use of ospemifene for the treatment of dyspareunia associated with VVA due to menopause and provides an overview of its clinical safety. Keywords: genitourinary syndrome of menopause, SERM, sexual dysfunctionWurz GTKao CJDeGregorio MWDove Medical PressarticleOspemifene SERM Dyspareunia Vaginal Dryness Vulvar and Vaginal AtrophyGeriatricsRC952-954.6ENClinical Interventions in Aging, Vol Volume 9, Pp 1939-1950 (2014)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ospemifene SERM Dyspareunia Vaginal Dryness Vulvar and Vaginal Atrophy Geriatrics RC952-954.6
spellingShingle	Ospemifene SERM Dyspareunia Vaginal Dryness Vulvar and Vaginal Atrophy Geriatrics RC952-954.6 Wurz GT Kao CJ DeGregorio MW Safety and efficacy of ospemifene for the treatment of dyspareunia associated with vulvar and vaginal atrophy due to menopause
description	Gregory T Wurz, Chiao-Jung Kao, Michael W DeGregorio Department of Internal Medicine, Division of Hematology and Oncology, University of California Davis, Sacramento, CA, USA Abstract: During the menopausal transition, women experience a number of symptoms due to declining estrogen levels, including vasomotor symptoms and vulvar and vaginal atrophy (VVA). Unlike vasomotor symptoms, vaginal dryness and dyspareunia, the main symptoms of VVA, typically worsen without treatment and can significantly impact the quality of life. Up to 60% of postmenopausal women may be affected by VVA, but many women unfortunately do not seek treatment due to embarrassment or other factors. After 20+ years in development, ospemifene (Osphena™) was approved by the US Food and Drug Administration in 2013 for treatment of moderate-to-severe dyspareunia associated with VVA due to menopause. As the first non-hormonal alternative to estrogen-based products for this indication, the approval of ospemifene represents a significant milestone in postmenopausal women’s health. Ospemifene is a non-steroidal estrogen receptor agonist/antagonist, also known as a selective estrogen receptor modulator (SERM), from the same chemical class as the breast cancer drugs tamoxifen and toremifene. Unlike other selective estrogen receptor modulators, ospemifene exerts a strong, nearly full estrogen agonist effect in the vaginal epithelium, making it well suited for the treatment of dyspareunia in postmenopausal women. Results of Phase III clinical trials showed that ospemifene significantly improved the vaginal maturation index (decreased parabasal cells and increased superficial cells), decreased vaginal pH, and decreased severity of the self-identified most bothersome symptom (dyspareunia or vaginal dryness) compared to placebo. Long-term safety studies revealed that 60 mg ospemifene given daily for 52 weeks was well tolerated and was not associated with any endometrium or breast-related safety concerns. This review discusses the preclinical and clinical data supporting the use of ospemifene for the treatment of dyspareunia associated with VVA due to menopause and provides an overview of its clinical safety. Keywords: genitourinary syndrome of menopause, SERM, sexual dysfunction
format	article
author	Wurz GT Kao CJ DeGregorio MW
author_facet	Wurz GT Kao CJ DeGregorio MW
author_sort	Wurz GT
title	Safety and efficacy of ospemifene for the treatment of dyspareunia associated with vulvar and vaginal atrophy due to menopause
title_short	Safety and efficacy of ospemifene for the treatment of dyspareunia associated with vulvar and vaginal atrophy due to menopause
title_full	Safety and efficacy of ospemifene for the treatment of dyspareunia associated with vulvar and vaginal atrophy due to menopause
title_fullStr	Safety and efficacy of ospemifene for the treatment of dyspareunia associated with vulvar and vaginal atrophy due to menopause
title_full_unstemmed	Safety and efficacy of ospemifene for the treatment of dyspareunia associated with vulvar and vaginal atrophy due to menopause
title_sort	safety and efficacy of ospemifene for the treatment of dyspareunia associated with vulvar and vaginal atrophy due to menopause
publisher	Dove Medical Press
publishDate	2014
url	https://doaj.org/article/83b025405eab4bb59a699d7f34d71146
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Safety and efficacy of ospemifene for the treatment of dyspareunia associated with vulvar and vaginal atrophy due to menopause

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