Effect of ospemifene on moderate or severe symptoms of vulvar and vaginal atrophy

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Effect of ospemifene on moderate or severe symptoms of vulvar and vaginal atrophy

OBJECTIVES To determine whether assessment of all moderate-to-severe symptoms at baseline gives a more accurate evaluation of the treatment effect of ospemifene in vulvovaginal atrophy (VVA) than the most bothersome symptom (MBS) approach. METHODS Data were pooled from two pivotal phase-III clinical trials evaluating the efficacy and safety of oral ospemifene 60 mg/day for the treatment of sy...

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

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 ...

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Clinical update on the use of ospemifene in the treatment of severe symptomatic vulvar and vaginal atrophy

The physiological decrease in vaginal estrogens is accountable for the emergence of vulvar and vaginal atrophy (VVA) and its related symptoms such as vaginal dryness, dyspareunia, vaginal and/or vulvar irritation or itching, and dysuria. The repercussion of these symptoms on quality of life often makes it necessary to initiate treatment. Up until now, the treatments available included vaginal m...

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Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy

OBJECTIVE Assessment of 12-month safety of ospemifene 60 mg/day for treatment of postmenopausal women with vulvar and vaginal atrophy (VVA). METHODS In this 52-week, randomized, double-blind, placebo-controlled, parallel-group study, women 40-80 years with VVA and an intact uterus were randomized 6 : 1 to ospemifene 60 mg/day or placebo. The primary objective was 12-month safety, particularly...

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ژورنال

عنوان ژورنال: Climacteric

سال: 2015

ISSN: 1369-7137,1473-0804

DOI: 10.3109/13697137.2015.1113517