RESUMEN
OBJECTIVE: To prospectively evaluate the effects of ospemifene on the vulva and vagina in postmenopausal women using vulvar-vestibular photography and direct visual assessments. METHODS: Postmenopausal women (aged 40-80 years) with moderate to severe vaginal dryness as their most bothersome symptom (MBS) were randomized to daily ospemifene 60âmg or placebo in this 12-week, multicenter, double-blind, phase 3 study. Vulvar-vestibular photographic images were captured at baseline and week 12 and were independently assessed with the Vulvar Imaging Assessment Scale (VIAS). Changes from baseline in Vaginal and Vulvar Health Indices (VHI and VuHI) with ospemifene versus placebo were analyzed at weeks 4, 8, and 12. Correlations between VIAS, VHI, and VuHI, with vaginal dryness severity and the Female Sexual Function Index (FSFI) scores were also assessed. RESULTS: In all, 631 eligible participants were randomized (ospemifene 316, placebo 315) and included in the intention-to-treat population. Compared with placebo, ospemifene significantly improved total scores for VIAS (Pâ=â0.0154), VHI (Pâ<â0.0001), and VuHI (Pâ<â0.0001) from baseline to week 12; significant VHI (Pâ<â0.0001) and VuHI (Pâ=â0.002) improvements were observed at week 4. Most VHI and VuHI individual items were significantly better with ospemifene versus placebo at week 12 (Pâ<â0.05). Most correlations between the vulvovaginal assessment total scores versus vaginal dryness severity and FSFI scores were significant (Pâ<â0.05). CONCLUSION: Improvements observed in vulvovaginal health with ospemifene assessed by prospective vulvar-vestibular photography and other direct visual assessments support its efficacy in addition to the treatment of moderate to severe vaginal dryness due to menopause and the use of photographic and direct visual evaluations in future clinical trials. VIDEO SUMMARY: Supplemental Digital Content 1, http://links.lww.com/MENO/A415.
Asunto(s)
Moduladores Selectivos de los Receptores de Estrógeno/uso terapéutico , Tamoxifeno/análogos & derivados , Vagina/patología , Enfermedades Vaginales/tratamiento farmacológico , Vulva/patología , Administración Oral , Adulto , Anciano , Anciano de 80 o más Años , Atrofia/tratamiento farmacológico , Estudios Transversales , Método Doble Ciego , Femenino , Humanos , Persona de Mediana Edad , Fotograbar , Estudios Prospectivos , Moduladores Selectivos de los Receptores de Estrógeno/administración & dosificación , Tamoxifeno/administración & dosificación , Tamoxifeno/uso terapéutico , Resultado del Tratamiento , Estados UnidosRESUMEN
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 60âmg 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 (nâ=â631; ospemifene [nâ=â316], placebo [nâ=â315]) had a mean age of 59.8 years, a mean body mass index of 27.2âkg/m, and most were white. Ospemifene significantly improved (Pâ<â0.0001) 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 (Pâ<â0.001), maturation value (Pâ<â0.0001), and the Female Sexual Function Index (Pâ<â0.05) also significantly improved with ospemifene versus placebo at week 12. Significantly more women responded (31.5% vs 6.0%; Pâ<â0.0001) or were satisfied (49.2% vs 33.8%; Pâ=â0.0007) 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.