Ospemifene 60mg tablets

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 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.

Abstract licence: CC BY

Dyspareunia in peri- and postmenopausal women is common, clinically consequential, and often undertreated in gynecologic practice. Although genitourinary syndrome of menopause (GSM) is a frequent contributor, intercourse-related pain may also reflect vestibular, pelvic floor, dermatologic, inflammatory, treatment-related, and psychosocial factors. This narrative review provides a practical phenotype-based framework for assessment and management when GSM, vestibular pain, and pelvic floor dysfunction coexist, and when deep-pain phenotypes require broader pelvic evaluation. PubMed/MEDLINE, the Cochrane Library, and selected guideline sources were searched for English-language literature published from January 2014 to March 2026, prioritizing guidelines, systematic reviews, randomized or sham-controlled trials, and examination-based studies relevant to office gynecology. History should distinguish superficial from deep pain, provoked from spontaneous symptoms, and urinary, dermatologic, inflammatory, and psychosocial features. Examination should proceed from vulva and vestibule to vagina and pelvic floor, with bimanual assessment and selective imaging when deeper pathology is suspected. Management includes education, irritant avoidance, moisturizers and lubricants, and prescription therapy for clinically significant GSM, usually low-dose vaginal estrogen, with prasterone or ospemifene as selected alternatives. Pelvic floor physiotherapy should be considered when tenderness, guarding, or penetration-limiting hypertonicity is present. Because menopause-specific pelvic floor evidence remains limited, related recommendations are framed as cautious extrapolations from broader dyspareunia, vulvodynia, and chronic pelvic pain literature.

Abstract licence: CC BY

Abstract Objective: To evaluate the safety and efficacy of ospemifene for the treatment of moderate to severe vaginal dryness in postmenopausal women with vulvovaginal atrophy (VVA). Methods: This 12-week, multicenter, double-blind phase 3 study randomized postmenopausal women (aged 40-80 years) with VVA and moderate to severe vaginal dryness as their most bothersome symptom to daily oral ospemifene 60 mg or placebo. Coprimary efficacy endpoints included changes from baseline to week 12 in percentages of vaginal parabasal and superficial cells, vaginal pH, and vaginal dryness severity with ospemifene versus placebo; other secondary endpoints were evaluated (weeks 4, 8, and 12). Safety was assessed by treatment-emergent adverse events (TEAEs) and endometrial biopsies. Results: Women (n = 631; ospemifene [n = 316], placebo [n = 315]) had a mean age of 59.8 years, a mean body mass index of 27.2 kg/m 2 , and most were white. Ospemifene significantly improved ( P  < 0.0001) the percentages of parabasal and superficial cells, vaginal pH, and severity of vaginal dryness severity compared with placebo at week 12; significant between-group differences were noted by week 4. Secondary endpoints of dyspareunia ( P  < 0.001), maturation value ( P  < 0.0001), and the Female Sexual Function Index ( P  < 0.05) also significantly improved with ospemifene versus placebo at week 12. Significantly more women responded (31.5% vs 6.0%; P  < 0.0001) or were satisfied (49.2% vs 33.8%; P  = 0.0007) with ospemifene versus placebo at week 12. No unexpected TEAEs, treatment-related serious TEAEs, thrombotic events, or endometrial hyperplasia or carcinoma were observed. Conclusions: Ospemifene was effective and well tolerated for the treatment of moderate-to-severe vaginal dryness in postmenopausal women with VVA.

Abstract licence: CC BY-NC-ND 4.0