Ospemifene

Genitourinary syndrome of menopause (GSM) has a significantly negative impact on affected women's lives. However, despite the increasing number of GSM treatment options (e.g. non-hormonal vaginal products, vaginal hormones [estrogens], dehydroepiandrosterone [DHEA; prasterone], vaginal laser therapy, oral ospemifene), many women remain untreated. The goal of the Swiss interdisciplinary GSM consensus meeting was to develop tools for GSM management in daily practice: a GSM management algorithm (personalized medicine); a communication tool for vaginal DHEA (drug facts box); and a communication tool for understanding regulatory authorities and the discrepancy between scientific data and package inserts...

Menopause represents an endocrine challenge to urogenital health, as oestrogens deprivation and androgens decline significantly contributes to age-related involution of vulvovaginal tissues and lower urinary tract. Genitourinary syndrome of menopause (GSM) is a clinical entity including the chronic and progressive condition of vulvovaginal atrophy (VVA) and encompassing both anatomical and functional consequences of menopause. The term GSM describes genital, sexual and urinary symptoms with a detrimental impact on quality of life (QOL)...

Urogenital aging is a common process affecting all women in the post-menopausal period of their life, and it is substantially due to oestrogen deprivation after ovarian function cessation. These changes can lead to a progressive, chronic, and complex association of symptoms identified as the genitourinary syndrome of menopause, which has a significant impact on quality of life. Genitourinary syndrome and urogenital aging do not resolve spontaneously and usually recur when treatment is stopped. Therefore, appropriate long-term management is of paramount importance, and local oestrogen is the most effective treatment to reverse urogenital aging and to improve symptoms of genitourinary syndrome as replacement therapy...

OBJECTIF: Proposer des stratégies fondées sur les plus récentes données publiées pour améliorer les soins aux femmes ménopausées ou en périménopause. POPULATION CIBLE: Les femmes ménopausées ou en périménopause. BéNéFICES, RISQUES ET COûTS: La population cible bénéficiera des plus récentes données scientifiques publiées communiquées par leurs fournisseurs de soins de santé. Aucun coût ni préjudice ne sont associés à cette information, car les femmes seront libres de choisir parmi les différentes options thérapeutiques, y compris le statu quo, pour la prise en charge des symptômes et morbidités associés à la ménopause...

New therapeutic options are being considered to treat genitourinary syndrome of menopause (GSM), such as vaginal laser, ospemifene, or prasterone, but there is no explicit agreement in the scientific community for its use. Some concerns have arisen on how to evaluate the improvement of GSM symptoms. In 2003, the FDA suggested possible end points for this purpose: change in severity of symptoms, change in vaginal pH, and change in vaginal maturation index (VMI). Contrarily, the most common assessment tools used to quantify severity and improvement of GSM nowadays are the visual analog scale of GSM symptoms, the vaginal health index, and the female sexual function index...

OBJECTIVE: Provide strategies for improving the care of perimenopausal and postmenopausal women based on the most recent published evidence. TARGET POPULATION: Perimenopausal and postmenopausal women. BENEFITS, HARMS, AND COSTS: Target population will benefit from the most recent published scientific evidence provided via the information from their health care provider. No harms or costs are involved with this information since women will have the opportunity to choose among the different therapeutic options for the management of the symptoms and morbidities associated with menopause, including the option to choose no treatment...

AIMS: To evaluate the efficacy of Ospemifene in the vaginal health index (VHI), in the vulvovaginal vascular perfusion and to assess its impact on quality of life and sexual function. METHODS: Among 52 eligible patients, 43 consecutive postmenopausal patients affected by vulvo-vaginal atrophy (VVA) or Genitourinary Syndrome (GSM) were evaluated. VVA evaluation and ultrasound of the vulvo-vaginal vascularization by sampling the pulsatility index (PI) of clitoris dorsal artery were performed before and after 3 months-treatment with Ospemifene...

Genitourinary syndrome of menopause (GSM) occurs in approximately 50% of menopausal women but is both underrecognized and undertreated despite numerous treatment options. Vaginal dryness, irritation, dyspareunia, urinary frequency, and urinary urgency are some of the more common symptoms that can have a negative effect on women's lives and relationships. Treatment options can include over-the-counter moisturizers and lubricants that can be composed of water or silicone or have an oil base. However, women and health care providers need be aware of the effects of excipients in these products so that the therapy does not cause vaginal irritation...

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...

Selective estrogen receptor (ER) modulators have variable tissue specific estrogen agonist and antagonist activities. Tamoxifen is approved for treatment and prevention of breast cancer; acts as an endometrial estrogen agonist. Raloxifene is approved for prevention and treatment of osteoporosis and prevention of breast cancer. The selective ER modulators bazedoxifene paired with conjugated estrogens relieves vasomotor symptoms and prevents bone loss with neutral effects on breast and amenorrhea similar to placebo...

Selective estrogen receptor modulators (SERMs) are synthetic molecules that bind to the estrogen receptor and can have agonistic activity in some tissues while being estrogen antagonistic in others. While not all SERMs are clinically available in all parts of the world, this article will review preclinical and clinical effects of various SERMs on bone. These include tamoxifen, used as adjuvant therapy in breast cancer patients as well as for breast cancer prevention; raloxifene, approved for osteoporosis prevention and treatment as well as breast cancer prevention; bazedoxifene, approved for prevention of osteoporosis and also in combination with conjugated equine estrogen for treatment of vasomotor symptoms and prevention of bone loss in postmenopausal patients; and ospemifene, approved for treatment of dyspareunia due to vulvovaginal atrophy/genitourinary syndrome of menopause...

OBJECTIVE: To develop a best practice document for the management of postmenopausal vulvovaginal atrophy (VVA). METHOD: Literature review carried out using clinical terms, treatments or interventions and comorbidity related to VVA. RESULTS: There is a wide variety of interventions that may produce temporal benefits for VVA. However, there are significant limitations in scientific publications concerning VVA and related issues, including variable outcome evaluations, variability in population age range, and small, often underpowered sample sizes...

Introduction : Menopausal symptoms can be very overwhelming for women. Over the years, many pharmacotherapeutic options have been tested, and others are still being developed. Hormone therapy (HT) is the most efficient therapy for managing vasomotor symptoms and related disturbances. The term HT comprises estrogens and progestogens, androgens, tibolone, the tissue-selective estrogen complex (TSEC), a combination of bazedoxifene and conjugated estrogens, and the selective estrogen receptor modulators, such as ospemifene...

Postmenopausal atrophic vaginitis, along with vasomotor symptoms and sleep disorders, is one of the most troublesome symptoms of menopause. However, many women do not manage this symptom properly due to insufficient knowledge of the symptoms or sexual embarrassment. With appropriate treatment, many postmenopausal women can experience relief from discomforts, including burning sensation or dryness of the vagina and dyspareunia. Topical lubricants and moisturizers, systemic and local estrogens, testosterones, intravaginal dehydroepiandrosterones (DHEAs), selective estrogen receptor modulators, and energy-based therapies are possible treatment modalities...

INTRODUCTION: Genitourinary menopause syndrome (SGUM) is defined as a set of symptoms associated with a decrease of estrogen and other sexual steroids during menopause. The main symptoms are vulvovaginal (dryness, burning, itching), sexual (dyspareunia), and urinary (urinary infections, pollakiuria, nycturia, pain, urinary incontinence by urgenturia). SGUM leads to an alteration of the quality of life, and affects especially women's sexuality. OBJECTIVE: The objective of this review was to elaborate guidelines for clinical practice regarding the management of SGUM in postmenopausal women, and in particular, in women with a history of breast cancer, treated or not with hormone therapy...

The genitourinary syndrome of menopause (GSM) is the accepted term used to describe the broad spectrum of genitourinary tract symptoms and signs caused by the loss of endogenous sex steroids that occurs at the time of and after the menopause. Global improvements in healthcare have resulted in an ageing population. Today, women are spending 40% of their lives in the postmenopausal state, and with 50-70% of postmenopausal women reporting symptomatic GSM, safe and efficacious treatments are needed for this troublesome condition...

OBJECTIVE: The objective of this study was to present an updated picture of the knowledge and attitudes of Italian gynecologists with regard to the genitourinary syndrome of menopause (GSM). STUDY DESIGN: An anonymous survey was sent via electronic mail to 3892 gynecologists. The survey consisted of 32 multiple-choice questions divided into four different areas: 1. general demographics of the respondents; 2. knowledge of GSM; 3. most frequently prescribed therapies; and 4...

Genitourinary syndrome of menopause (GSM) seriously affects the quality of life of women in this stage and patients with breast cancer, but optimal treatment options as well as risks associated with the complication remain controversial. We aimed at exploring the safest and most effective treatment for genitourinary syndrome of menopause. The study was performed following a pre-established protocol registered on PROSPERO (CRD42020180807). We searched through PubMed, Embase, Scopus, Cochrane Library, Web of Science and ScienceDirect electronic databases, clinicaltrials...

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...

OBJECTIVE: To estimate the incidence and recurrence of breast cancer (BC) in patients with vulvovaginal atrophy (VVA) treated with ospemifene and matched untreated VVA patients using real-world data. STUDY DESIGN: Retrospective matched cohort study. MAIN OUTCOME MEASURES: VVA patients were identified from the 2011-2018 US MarketScan® insurance claims database. For incidence, ospemifene-treated VVA patients without evidence of BC prior to index treatment were matched to two untreated VVA controls similarly without history of BC on age, index VVA year, geographic region, Charlson Comorbidity categories, and follow-up time...