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Keywords = ospemifene

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21 pages, 1501 KB  
Review
Case-Based Perspectives on the Management of Genitourinary Syndrome of Menopause
by Jissy Cyriac and Richa Sood
Clin. Pract. 2026, 16(3), 60; https://doi.org/10.3390/clinpract16030060 - 12 Mar 2026
Cited by 1 | Viewed by 2746
Abstract
Background and Objectives: Genitourinary syndrome of menopause (GSM), previously known as vulvovaginal atrophy, is a chronic, progressive hypoestrogenic condition affecting vulvovaginal, urinary and sexual health in women. Common symptoms include vaginal dryness, itching, dyspareunia, urinary urgency and recurrent urinary tract infections (UTIs). Despite [...] Read more.
Background and Objectives: Genitourinary syndrome of menopause (GSM), previously known as vulvovaginal atrophy, is a chronic, progressive hypoestrogenic condition affecting vulvovaginal, urinary and sexual health in women. Common symptoms include vaginal dryness, itching, dyspareunia, urinary urgency and recurrent urinary tract infections (UTIs). Despite the high prevalence, GSM is underdiagnosed and undertreated, thereby negatively impacting women’s quality of life. To illustrate the practical aspects of GSM diagnosis and provide evidence-based management, we present a case-based narrative review synthesizing recently published, high-quality evidence. Materials and Methods: Evidence was drawn from multiple sources through targeted searches of databases, and included the 2025 AUA/SUFU/AUGS guideline (AUA), the 2024 NICE network meta-analyses (NICE), a 2025 systematic review/meta-analysis in breast-cancer survivors, the 2020 Menopause Society GSM Position Statement, the 2018 NAMS/ISSWSH breast cancer consensus, several primary source citations and other high quality peer-reviewed publications. Results: Five illustrative composite case vignettes of GSM are presented to highlight the evaluation strategy and evidence-supported treatment choices. Nonhormonal options are the first line treatments for mild GSM symptoms, either with or without the addition of vaginal estrogen therapy. For moderate to severe GSM, low-dose vaginal estrogen, vaginal DHEA, and ospemifene are all effective FDA-approved options. In breast cancer survivors, individualized decisions with oncology input are warranted. Maximal caution and a shared decision-making approach is required for women using Aromatase Inhibitors (AIs) for breast cancer risk reduction when choosing treatments for GSM. Conclusions: Treating GSM improves vaginal, sexual and urinary outcomes and quality of life of women. Clinicians need to proactively screen for GSM and offer evidence-based treatment options. The treatment decisions in breast cancer survivors are nuanced, requiring a shared-decision approach. Full article
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15 pages, 517 KB  
Review
Update on Genitourinary Syndrome of Menopause: A Scoping Review of a Tailored Treatment-Based Approach
by Ilaria Cuccu, Tullio Golia D’Augè, Ilaria Firulli, Emanuele De Angelis, Giovanni Buzzaccarini, Ottavia D’Oria, Aris Raad Besharat, Donatella Caserta, Giorgio Bogani, Ludovico Muzii, Violante Di Donato and Andrea Giannini
Life 2024, 14(11), 1504; https://doi.org/10.3390/life14111504 - 19 Nov 2024
Cited by 13 | Viewed by 16126
Abstract
This scoping review explores the therapeutic strategies available for managing genitourinary syndrome of menopause (GSM), a condition often underdiagnosed and undertreated despite significantly affecting women’s quality of life. GSM results from decreased estrogen levels during menopause, leading to a range of symptoms including [...] Read more.
This scoping review explores the therapeutic strategies available for managing genitourinary syndrome of menopause (GSM), a condition often underdiagnosed and undertreated despite significantly affecting women’s quality of life. GSM results from decreased estrogen levels during menopause, leading to a range of symptoms including vulvovaginal atrophy and urinary tract issues. Material and Methods: we screened the literature for original studies with “menopause”, “hormonal therapy”, “vulvovaginal atrophy”, “urinary incontinence”, “urinary infections”, “genitourinary syndrome”. Results: A total of 451 relevant articles were retrieved. After screening, 19 articles were included in this scoping review. Discussion: First-line treatments typically include lubricants and moisturizers for short-term symptom relief, while unresolved or severe cases may warrant hormonal treatment. Topical hormonal treatments often have fewer side effects than systemic alternatives. Special attention is given to selective estrogen receptor modulators like ospemifene and steroid hormones like dehydroepiandrosterone (DHEA), which have shown beneficial effects on GSM symptoms. Moreover, innovative therapeutic approaches, such as laser treatment, are discussed in the context of their efficacy and accessibility. The safety of GSM hormonal therapy in women with a history or risk of cancer is also addressed, noting the need for more definitive research in this area. While there is a growing demand for tailored therapy, this scoping review emphasizes the importance of effective communication and counseling to allow women to make informed decisions about their treatment. Overall, this review underscores the need for increased awareness and further research into effective treatment options for GSM. Full article
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15 pages, 2704 KB  
Systematic Review
Effect of Vaginal Laser and Topical Therapies on Vulvovaginal Atrophy Symptoms in Breast Cancer Patients: A Systematic Review and Meta-Analysis
by Lotti Lúcia Lőczi, Gábor Vleskó, Máté Éliás, Caner Turan, Panna Kajtár, Réka Tóth, Miklós Sipos, Rita Nagy, Péter Hegyi, Nándor Ács, Szabolcs Várbíró and Márton Keszthelyi
J. Clin. Med. 2024, 13(20), 6131; https://doi.org/10.3390/jcm13206131 - 15 Oct 2024
Cited by 4 | Viewed by 3450
Abstract
Background: Vulvovaginal atrophy (VVA) significantly impacts the quality of life in breast cancer patients leading to symptoms like vaginal dryness, dyspareunia, and genital discomfort. Quality of life in this context is measured using validated scales like the Vaginal Health Index, Visual Analog [...] Read more.
Background: Vulvovaginal atrophy (VVA) significantly impacts the quality of life in breast cancer patients leading to symptoms like vaginal dryness, dyspareunia, and genital discomfort. Quality of life in this context is measured using validated scales like the Vaginal Health Index, Visual Analog Scale (VAS), and the Female Sexual Function Index (FSFI). Methods: We performed a systematic review and meta-analysis to identify effective treatment options for VVA, including topical estrogen, systemic hormone therapy, vaginal DHEA, ospemifene, and non-hormonal methods like intravaginal laser therapy, moisturizers, and lubricants. A systematic search of four databases (MEDLINE, Scopus, CENTRAL, Embase) identified studies on VVA treatment efficacy in breast cancer patients, yielding 13,039 records, with 32 eligible studies and 8 included in the meta-analysis. Results: Significant improvements were found with intravaginal laser therapy, showing notable differences in the Vaginal Health Index (MD = 8.24, p < 0.01), dyspareunia (MD = −4.82, p = 0.05), and dryness (MD = −5.05, p = 0.01). However, no significant changes were observed in FSFI and vaginal pH. Notably only intravaginal laser therapy was included in the meta-analysis, as other treatment options lacked comparable data. Both hormonal and non-hormonal treatments improved quality of life, with laser therapy showing the most substantial effects. Conclusions: Intravaginal laser therapy is an effective treatment for VVA symptoms in breast cancer survivors, particularly in improving the Vaginal Health Index and reducing dyspareunia. Despite the strengths of the study, variability among studies, lack of RCT-s and data limitations, especially on long-term effects, present challenges. Full article
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27 pages, 661 KB  
Systematic Review
Therapeutic Choices for Genitourinary Syndrome of Menopause (GSM) in Breast Cancer Survivors: A Systematic Review and Update
by Lucia Merlino, Giulia D’Ovidio, Viviana Matys, Maria Grazia Piccioni, Maria Grazia Porpora, Roberto Senatori, Maria Federica Viscardi, Antonio Vitale, Carlo Della Rocca and on behalf of Policlinico Umberto I Collaborators
Pharmaceuticals 2023, 16(4), 550; https://doi.org/10.3390/ph16040550 - 6 Apr 2023
Cited by 21 | Viewed by 11231
Abstract
(1) Background: Genitourinary syndrome of menopause (GSM) is a medical condition that can affect breast cancer survivors (BCS). This is a complication that often can occur as a result of breast cancer treatment, causing symptoms such as vaginal dryness, itching, burning, dyspareunia, dysuria, [...] Read more.
(1) Background: Genitourinary syndrome of menopause (GSM) is a medical condition that can affect breast cancer survivors (BCS). This is a complication that often can occur as a result of breast cancer treatment, causing symptoms such as vaginal dryness, itching, burning, dyspareunia, dysuria, pain, discomfort, and impairment of sexual function. BCS who experience these symptoms negatively impact multiple aspects of their quality of life to the point that some of them fail to complete adjuvant hormonal treatment; (2) Methods: In this systematic review of the literature, we have analyzed possible pharmacological and non-pharmacological treatments for GSM in BCS. We reviewed systemic hormone therapy, local hormone treatment with estrogens and androgens, the use of vaginal moisturizers and lubricants, ospemifene, and physical therapies such as radiofrequency, electroporation, and vaginal laser; (3) Results: The data available to date demonstrate that the aforementioned treatments are effective for the therapy of GSM and, in particular, vulvovaginal atrophy in BCS. Where possible, combination therapy often appears more useful than using a single line of treatment; (4) Conclusions: We analyzed the efficacy and safety data of each of these options for the treatment of GSM in BCS, emphasizing how often larger clinical trials with longer follow-ups are needed. Full article
(This article belongs to the Section Pharmacology)
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9 pages, 511 KB  
Article
Effect of Ospemifene on Densitometric and Plasma Bone Metabolism Biomarkers in Postmenopausal Women Reporting Vulvar and Vaginal Atrophy (VVA)
by Silvia Maffei and Letizia Guiducci
J. Clin. Med. 2022, 11(21), 6316; https://doi.org/10.3390/jcm11216316 - 26 Oct 2022
Cited by 7 | Viewed by 2814
Abstract
Menopausal hormone deficiency can exert multiple effects on various organs. Vulvovaginal atrophy (VVA) is among the most widespread and disabling post-menopausal disorder. Hormonal changes can also result in a markedly increased rate of bone mineral density (BMD) loss. Ospemifene (OSP) is an SERM [...] Read more.
Menopausal hormone deficiency can exert multiple effects on various organs. Vulvovaginal atrophy (VVA) is among the most widespread and disabling post-menopausal disorder. Hormonal changes can also result in a markedly increased rate of bone mineral density (BMD) loss. Ospemifene (OSP) is an SERM indicated to treat vulvar and vaginal atrophy (VVA) in postmenopausal women. This study evaluates the long-term effects of ospemifene therapy on bone metabolism and bone mineral parameters in postmenopausal women reporting VVA/GSM. Methods: Women reporting VVA symptoms were included. Bone health profile was investigated in 61 subjects treated with OSP (OSPG) (60 mg/day) and compared with a control group (CG) (n = 67) over 12 months. Results: In the CG, BMD and T-score statistically decreased at the femoral neck (FN), total femur (TF), and lumbar spine (L1–L4). In the OSPG, BMD decreased significantly at FN but tended to remain stable at TF and L1–L4. No changes were observed in bone mineral markers after one year in either group, except BAP, which decreased in OSPG. Conclusions: Long-term OSP treatment improves bone mineral markers at TF and LS and slows bone loss at FN compared to the control group. Overall, OSP exerts a protective effect on bone loss in healthy menopausal women with VVA. Full article
(This article belongs to the Special Issue Postmenopausal Osteoporosis: Prevention and Management)
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13 pages, 374 KB  
Review
New Innovations for the Treatment of Vulvovaginal Atrophy: An Up-to-Date Review
by Vittoria Benini, Alessandro Ferdinando Ruffolo, Arianna Casiraghi, Rebecca S. Degliuomini, Matteo Frigerio, Andrea Braga, Maurizio Serati, Marco Torella, Massimo Candiani and Stefano Salvatore
Medicina 2022, 58(6), 770; https://doi.org/10.3390/medicina58060770 - 6 Jun 2022
Cited by 59 | Viewed by 15837
Abstract
Vulvovaginal atrophy (VVA) is a chronic progressive disease involving the female genital apparatus and lower urinary tract. This condition is related to hypoestrogenism consequent to menopause onset but is also due to the hormonal decrease after adjuvant therapy for patients affected by breast [...] Read more.
Vulvovaginal atrophy (VVA) is a chronic progressive disease involving the female genital apparatus and lower urinary tract. This condition is related to hypoestrogenism consequent to menopause onset but is also due to the hormonal decrease after adjuvant therapy for patients affected by breast cancer. Considering the high prevalence of VVA and the expected growth of this condition due to the increase in the average age of the female population, it is easy to understand its significant social impact. VVA causes uncomfortable disorders, such as vaginal dryness, itching, burning, and dyspareunia, and requires constant treatment, on cessation of which symptoms tend to reappear. The currently available therapies include vaginal lubricants and moisturizers, vaginal estrogens and dehydroepiandrosterone (DHEA), systemic hormone therapy, and Ospemifene. Considering, however, that such therapies have some problems that include contraindications, ineffectiveness, and low compliance, finding an innovative, effective, and safe treatment is crucial. The present data suggest great efficacy and safety of a vaginal laser in the treatment of genital symptoms and improvement in sexual function in patients affected by VVA. The beneficial effect tends to be sustained over the long-term, and no serious adverse events have been identified. The aim of this review is to report up-to-date efficacy and safety data of laser energy devices, in particular the microablative fractional carbon dioxide laser and the non-ablative photothermal Erbium-YAG laser. Full article
(This article belongs to the Section Obstetrics and Gynecology)
9 pages, 312 KB  
Review
Management of Hypertension with Female Sexual Dysfunction
by Qing Zhong and Yuri Anderson
Medicina 2022, 58(5), 637; https://doi.org/10.3390/medicina58050637 - 5 May 2022
Cited by 15 | Viewed by 10027
Abstract
Female sexual dysfunction (FSD) in hypertension has been less studied than male sexual dysfunction, and antihypertensive agents’ impact on female sexual function is not defined. In this review, randomized double-blind clinical trials and cross-sectional studies related to female sexual function in hypertension were [...] Read more.
Female sexual dysfunction (FSD) in hypertension has been less studied than male sexual dysfunction, and antihypertensive agents’ impact on female sexual function is not defined. In this review, randomized double-blind clinical trials and cross-sectional studies related to female sexual function in hypertension were analyzed from 1991 to 2021. FSD appeared to be higher in hypertensive women than in normotensive women. Beta-blockers are the only antihypertensive agents with relatively strong evidence of damaging the female sexual function. Angiotensin receptor blockers (ARB) are relatively beneficial to female sexual function. To treat FSD in the presence of hypertension, controlling blood pressure is key, and the administration of angiotensin receptor blockers is preferred. In addition to controlling blood pressure, for premenopausal women, flibanserin and bremelanotide can be tried, while ospemifene and hormone supplements are preferred for postmenopausal women. Full article
(This article belongs to the Section Pharmacology)
12 pages, 664 KB  
Article
Effects of Ospemifene on Drug Metabolism Mediated by Cytochrome P450 Enzymes in Humans in Vitro and in Vivo
by Miia Turpeinen, Jouko Uusitalo, Terhi Lehtinen, Marita Kailajärvi, Olavi Pelkonen, Jouni Vuorinen, Pasi Tapanainen, Camilla Stjernschantz, Risto Lammintausta and Mika Scheinin
Int. J. Mol. Sci. 2013, 14(7), 14064-14075; https://doi.org/10.3390/ijms140714064 - 5 Jul 2013
Cited by 13 | Viewed by 8322
Abstract
The objective of these investigations was to determine the possible effects of the novel selective estrogen receptor modulator, ospemifene, on cytochrome P450 (CYP)-mediated drug metabolism. Ospemifene underwent testing for possible effects on CYP enzyme activity in human liver microsomes and in isolated human [...] Read more.
The objective of these investigations was to determine the possible effects of the novel selective estrogen receptor modulator, ospemifene, on cytochrome P450 (CYP)-mediated drug metabolism. Ospemifene underwent testing for possible effects on CYP enzyme activity in human liver microsomes and in isolated human hepatocytes. Based on the results obtained in vitro, three Phase 1 crossover pharmacokinetic studies were conducted in healthy postmenopausal women to assess the in vivo effects of ospemifene on CYP-mediated drug metabolism. Ospemifene and its main metabolites 4-hydroxyospemifene and 4'-hydroxyospemifene weakly inhibited a number of CYPs (CYP2B6, CYP2C9, CYP2C19, CYP2C8, and CYP2D6) in vitro. However, only CYP2C9 activity was inhibited by 4-hydroxyospemifene at clinically relevant concentrations. Induction of CYPs by ospemifene in cultured human hepatocytes was 2.4-fold or less. The in vivo studies showed that ospemifene did not have significant effects on the areas under the plasma concentration-time curves of the tested CYP substrates warfarin (CYP2C9), bupropion (CYP2B6) and omeprazole (CYP2C19), demonstrating that pretreatment with ospemifene did not alter their metabolism. Therefore, the risk that ospemifene will affect the pharmacokinetics of drugs that are substrates for CYP enzymes is low. Full article
(This article belongs to the Special Issue Xenobiotic Metabolism)
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