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      The clinical relevance of the effect of ospemifene on symptoms of vulvar and vaginal atrophy

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          Abstract

          Objectives

          To explore clinically relevant differences in severity of vulvar and vaginal atrophy (VVA) in postmenopausal women treated with ospemifene compared with placebo.

          Methods

          Analysis of two multicenter, randomized, double-blind, 12-week phase-III studies in postmenopausal women (40–80 years, with VVA, treated with ospemifene 60 mg/day or placebo (Study 310 and Study 821)). Severity of vaginal dryness and dyspareunia were evaluated using a four-point scoring system and clinically relevant differences between ospemifene and placebo were analyzed and are presented as improvement (reduction in ≥ 1 unit on four-point scoring system), substantial improvement (reduction in 2–3 units on four-point scoring system) and relief (severity score of mild/none after 12 weeks).

          Results

          In Study 310, significantly more women with a most bothersome symptom of dyspareunia had improvement (68.3% vs. 54.1%; p = 0.0255) or relief (57.5% vs. 41.8%; p = 0.0205) in the severity of dyspareunia from baseline to week 12 with ospemifene compared with placebo. For those with a most bothersome symptom of vaginal dryness, significantly more experienced improvement (74.6% vs. 57.7%; p = 0.0101), substantial improvement (42.4% vs. 26.9%; p = 0.0172) and relief (66.1% vs. 49.0%; p = 0.0140) of vaginal dryness from baseline to week 12 with ospemifene compared with placebo. Proportions of women with improvement/substantial improvement/relief of symptoms of vaginal dryness or dyspareunia were similar in Study 821. Clinically relevant differences were noticeable by week 4.

          Conclusions

          Treatment with ospemifene was consistently associated with greater improvement, substantial improvement or relief in the severity of the most bothersome symptoms of vaginal dryness or dyspareunia compared with placebo.

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          Most cited references33

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          Vulvovaginal atrophy.

          Vulvovaginal atrophy (VVA) is a common and underreported condition associated with decreased estrogenization of the vaginal tissue. Symptoms include dryness, irritation, soreness, and dyspareunia with urinary frequency, urgency, and urge incontinence. It can occur at any time in a woman's life cycle, although more commonly in the postmenopausal phase, during which the prevalence is close to 50%. Clinical findings include the presence of pale and dry vulvovaginal mucosa with petechiae. Vaginal rugae disappear, and the cervix may become flush with the vaginal wall. A vaginal pH of 4.6 or more supports the diagnosis of VVA. Even while taking systemic estrogen, 10% to 20% of women may still have residual VVA symptoms. Breast cancer treatment increases the prevalence of VVA because the surgical, endocrine, and chemotherapeutic agents used in its treatment can cause or exacerbate VVA. Local estrogen treatment for this group of women remains controversial.
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            Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey.

            Vulvar and vaginal atrophy (VVA) is a chronic medical condition experienced by many postmenopausal women. Symptoms include dyspareunia (pain with intercourse), vaginal dryness, and irritation and may affect sexual activities, relationships, and activities of daily life.
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              Recommendations for the management of postmenopausal vaginal atrophy.

              Unlike hot flushes and night sweats which resolve spontaneously in time, atrophic symptoms affecting the vagina and lower urinary tract are often progressive and frequently require treatment. The prevalence of vaginal dryness increases as a woman advances through the postmenopausal years, causing itching, burning and dyspareunia, and sexual activity is often compromised. But, despite the various safe and effective options, only a minority (about 25% in the Western world and probably considerably less in other areas) will seek medical help. Some of this reluctance is due to the adverse publicity for hormone replacement therapy (HRT) over recent years that has suggested an increased risk of breast cancer, heart disease and stroke. But, regardless of whether these scares are justified, local treatment of vaginal atrophy is not associated with these possible risks of systemic HRT. Other reasons for the continued suffering in silence may be cultural and an understandable reluctance to discuss such matters, particularly with a male doctor, but the medical profession must also take much of the blame for failing to enquire of all postmenopausal women about the possibility of vaginal atrophic symptoms. Vaginal dryness can be helped by simple lubricants but the best and most logical treatment for urogenital atrophy is to use local estrogen. This is safe, effective and with few contraindications. It is hoped that these guidelines and recommendations, produced to coincide with World Menopause Day 2010, will help to highlight this major cause of distress and reduced quality of life and will encourage women and their medical advisers all over the world to seek and provide help.
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                Author and article information

                Contributors
                Journal
                Climacteric
                Climacteric
                dcli
                Climacteric
                Taylor & Francis
                1369-7137
                1473-0804
                March 2015
                16 December 2014
                : 18
                : 2
                : 233-240
                Affiliations
                Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS S Matteo Foundation, University of Pavia , Pavia, Italy
                []Queen Charlotte's and Chelsea Hospital, and Chelsea and Westminster Hospitals , London, and Imperial College, London, UK
                []BrInPhar Ltd , Iver Heath, UK
                []Clinic Institute of Gynecology, Obstetrics and Neonatology, Hospital Clinic and Faculty of Medicine, University of Barcelona - Institut d'Investigacions Biomèdiques August Pi i Sunyer , Barcelona, Spain
                [∗∗ ]Mediclinic Panorama and Department of Obstetrics and Gynecology, Faculty of Health Sciences, Stellenbosch University , Parow, South Africa
                [†† ]Department of Obstetrics and Gynecology, George Washington University, Women's Health & Research Consultants® , Washington, DC, USA
                Author notes
                Correspondence: Professor R. E. Nappi, Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS San Matteo Foundation, University of Pavia , Piazzale Golgi 2, 27100 Pavia, Italy; E-mail: renappi@ 123456tin.it
                Article
                975199
                10.3109/13697137.2014.975199
                4438339
                25335119
                f9cab297-1b3d-4c04-b98d-b0a86e6cadd3
                © 2014 International Menopause Society

                This is an open access article distributed under the Supplemental Terms and Conditions for iOpenAccess articles published in Taylor & Francis journals , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                This is an open-access article distributed under the terms of the CC-BY-NC-ND 3.0 License which permits users to download and share the article for non-commercial purposes, so long as the article is reproduced in the whole without changes, and provided the original source is credited.

                History
                : 11 August 2014
                : 22 September 2014
                : 6 October 2014
                Page count
                Figures: 3, Tables: 2, References: 36, Pages: 8
                Categories
                Original Article

                Obstetrics & Gynecology
                vulvar and vaginal atrophy,vaginal dryness,dyspareunia,ospemifene,randomized clinical trials

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