Dataset Information

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

ABSTRACT: To explore clinically relevant differences in severity of vulvar and vaginal atrophy (VVA) in postmenopausal women treated with ospemifene compared with placebo.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 vaginal dryness and dyspareunia were evaluated using a four-point scoring system and clinically relevant differences between ospemifene and placebo were analyzed and are presented as improvement (reduction in ? 1 unit on four-point scoring system), substantial improvement (reduction in 2-3 units on four-point scoring system) and relief (severity score of mild/none after 12 weeks).In Study 310, significantly more women with a most bothersome symptom of dyspareunia had improvement (68.3% vs. 54.1%; p = 0.0255) or relief (57.5% vs. 41.8%; p = 0.0205) in the severity of dyspareunia from baseline to week 12 with ospemifene compared with placebo. For those with a most bothersome symptom of vaginal dryness, significantly more experienced improvement (74.6% vs. 57.7%; p = 0.0101), substantial improvement (42.4% vs. 26.9%; p = 0.0172) and relief (66.1% vs. 49.0%; p = 0.0140) of vaginal dryness from baseline to week 12 with ospemifene compared with placebo. Proportions of women with improvement/substantial improvement/relief of symptoms of vaginal dryness or dyspareunia were similar in Study 821. Clinically relevant differences were noticeable by week 4.Treatment with ospemifene was consistently associated with greater improvement, substantial improvement or relief in the severity of the most bothersome symptoms of vaginal dryness or dyspareunia compared with placebo.

SUBMITTER: Nappi RE

PROVIDER: S-EPMC4438339 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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

Nappi R E RE Panay N N Bruyniks N N Castelo-Branco C C De Villiers T J TJ Simon J A JA

Climacteric : the journal of the International Menopause Society 20141216 2

<h4>Objectives</h4>To explore clinically relevant differences in severity of vulvar and vaginal atrophy (VVA) in postmenopausal women treated with ospemifene compared with placebo.<h4>Methods</h4>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 vaginal dryness and dyspareunia were evaluated using a four-point scoring system and clini ...[more]

PMID: 25335119

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Project description:Knowledge of female genital anatomy and physiology is often inadequate or incorrect among women. Precise patient-physician conversations can be inhibited by a reluctance or inability to speak accurately about the vulva and vagina, with the terms often being used interchangeably. There is a paucity of scientific evidence and clinical guidelines to support women and physicians in ensuring best practices in feminine hygiene. In this review, the unmet needs in the field are highlighted. Evidence is provided for the complex array of physiological and pathological systems, mechanisms and behaviours that either protect or, if inappropriate, predispose the vulva and vagina to infections, irritation or other conditions. The need for attention to perineal health is recommended, given the interdependence of perineal and vulvar microbiota and the risk of colonic pathogens reaching the vulva and the vagina. Differences in feminine hygiene practices can vary widely across the world and among varying age groups, and suboptimal habits (such as vaginal douching or the use of certain cleansers) can be associated with increased risks of vulvar and vaginal conditions. Critical areas for discussion when advising women on their intimate health include: advice surrounding aesthetic vulvar cosmetic trends (such as depilation and genital cosmetic surgery), bowel health and habits, and protection against sexually transmitted infections. Routine, once-daily (maximum twice-daily) washing of the vulva with a pH-balanced, mild cleanser is optimal, ideally soon after bowel voiding, when feasible. Due to the finely balanced ecosystems of the vulva, the vagina and the perineal area, a scientific and clinical perspective is essential when determining the most appropriate vulvar cleansers based on their components. Correct intimate care may contribute to improved genital and sexual health and overall well-being. An increased awareness of correct practices will empower women to be the advocates of their own intimate health.

Project description:Purulent vulvar discharges, primarily caused by genito-urinary tract infections, are an important source of economic loss for swine producers due to sow culling and mortality. However, the agents that compose the vaginal microbiota of sows and their changes during infections are not well understood. The first goal of this study was to characterize and compare the vaginal bacterial content of healthy (HE, n = 40) and purulent vulvar discharge sows (VD, n = 270) by a culture-dependent method and MALDI-TOF MS identification. Secondly, we performed 16S rRNA targeted metagenomic approach (n = 72) to compare the vaginal microbiota between these groups. We found a wide variety of bacteria, with Proteobacteria, Firmicutes, and Bacteroidota being the most abundant phyla in both groups, as well as Escherichia-Shigella, Streptococcus, and Bacteroides at the genus level. Most agents identified in the sequencing method also grew in the culture-dependent method, showing the viability of these bacteria. Alpha diversity did not differ between HE and VD sows, regarding sample richness and diversity, but a beta-diversity index showed a different microbiota composition between these groups in two tested herds. ANCOM analysis revealed that Bacteroides pyogenes were more abundant in VD females and can be a marker for this group. Other agents also require attention, such as the Streptococcus dysgalactiae and Staphylococcus hyicus found in remarkably greater relative abundance in VD sows. Network analysis revealed important positive correlations between some potentially pathogenic genera, such as between Escherichia-Shigella, Trueperella, Streptococcus, Corynebacterium, and Prevotella, which did not occur in healthy sows. We conclude that the alteration of the vaginal microbiota between healthy and purulent vulvar discharge sows, although not extreme, could be due to the increase in the relative abundance of specific agents and to associations between potentially pathogenic bacteria.

Dataset Information

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

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

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