Pivotal trial results for Brisdelle™ (paroxetine) capsules, an FDA-approved non-hormonal therapy for vasomotor symptoms associated with menopaus

Noven Pharmaceuticals, Inc., has announced the publication of results from its two Phase 3 clinical studies in Menopause, the peer-reviewed, scientific journal of The North American Menopause Society. Brisdelle™, paroxetine capsules, 7.5 mg/day, was approved by the United States Food and Drug Administration in June 2013, for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, commonly referred to as hot flashes and night sweats...
Source: Health News from Medical News Today - Category: Consumer Health News Tags: Menopause Source Type: news

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eta Grochans Menopause, the permanent cessation of the menstrual cycle, marks the end of a woman’s reproductive lifespan. Menopausal hormonal therapy (MHT) can potentially skew the fatty acid profile increasing the risk for developing metabolic diseases and disorders of skeletal, gastrointestinal, and nervous systems. The aim of this study was to investigate the fatty acid profile of postmenopausal women receiving, and not receiving, hormone replacement therapy. A total of 156 healthy women with a mean age of 60 participated in this cross-sectional study. Gas chromatography with an Agilent Technologies 7890A ...
Source: International Journal of Environmental Research and Public Health - Category: Environmental Health Authors: Tags: Article Source Type: research
Conclusions: The evidence map provides an overview of DCIS research showing the range of management options and remaining decisional dilemmas that follow a diagnosis of DCIS. It maps the evidence in accessible tools to guide practice and future research. Video Summary:http://links.lww.com/MENO/A448.
Source: Menopause - Category: OBGYN Tags: Original Articles Source Type: research
Conclusions: We extend existing research by demonstrating that hormone therapy (HT) in subjective sleep cannot be fully explained by improvements in VMS bother or depressive symptoms. Research to examine the mechanism (s) underlying HT's effects on sleep would have public health significance for perimenopausal women and also advance our general understanding of the pathophysiology of impaired sleep.
Source: Menopause - Category: OBGYN Tags: Brief Report Source Type: research
Conclusion: Although oral hormone therapy improves VMS scores, there is a paucity of evidence on whether it improves HRQOL in menopausal women. Future studies using validated, patient-reported outcome measures that directly assess HRQOL are needed.
Source: Menopause - Category: OBGYN Tags: Review Articles Source Type: research
This study evaluated these relationships in recently menopausal women (52.45± 2.49 years of age) in the Kronos Early Estrogen Prevention Study (KEEPS) who were compliant to randomized, double-blinded treatment with oral conjugated equine estrogen (o-CEE, n=109), transdermal 17β-estradiol (t-E2, n=107), or placebo (n=146). Androstenedione, testosterone, 17β-estradiol, estrone, follicle stimulating hormone (FSH), and luteinizing hormone (LH) were measured in serum prior to (baseline) and 48 months after randomization to treatment. Descriptive summaries of hormone levels were performed, and multiple regressio...
Source: American Journal of Physiology. Regulatory, Integrative and Comparative Physiology - Category: Physiology Authors: Tags: Am J Physiol Regul Integr Comp Physiol Source Type: research
Authors: Li C, Wang L, Sun X, Yang X Abstract A large number of menopausal women report sleep disturbances along with psychological, somatic and urogenital menopausal symptoms. The aim of this study was to evaluate the efficacy of menopausal hormonal therapy (MHT) in improving subjective sleep quality and the severity of menopausal symptoms. An institutional ethics committee approved this retrospective chart review of 342 women treated with MHT for menopausal symptoms. Standard 28-day MHT consisted of the oral administration of 2 mg estradiol daily for 14 days, followed by 2 mg estradiol and 10 mg dydrogesterone da...
Source: Experimental and Therapeutic Medicine - Category: General Medicine Tags: Exp Ther Med Source Type: research
AbstractPurpose of ReviewThe purpose of this review article is to summarize the recent literature regarding the effect of hormone replacement therapy on pelvic floor disorders and its role as a preventative or treatment option.Recent FindingsThe recent evidence describing the effect of hormone replacement therapy on pelvic floor disorders is mainly limited to cohort studies, systematic reviews, and secondary analysis of randomized controlled trials such as the Women ’s Health Initiative and Nurses’ Health Study. There are few quality randomized controlled trials, especially within the last 5 years on this ...
Source: Current Bladder Dysfunction Reports - Category: Urology & Nephrology Source Type: research
Hormone therapy remains the most effective treatment for menopausal symptoms but decisions are complex, requiring an assessment of benefits and risks and determination of best treatment type, dose, and duration. Benefits exceed risks for most women with bothersome menopausal symptoms or high risk for fracture if initiated under age 60 years or within 10 years since menopause. Long-term mortality and safety data from the Women’s Health Initiative is reassuring, with no increase in deaths from cardiovascular disease or cancer compared with placebo after 18 years of follow-up and a trend towards less mortality in those ...
Source: Clinical Obstetrics and Gynecology - Category: OBGYN Tags: Clinical Dilemmas and Unresolved Issues in Gynecology Source Type: research
Heart failure (HF), the third leading cause of cardiovascular disease (CVD) mortality, remains poorly recognized and understood in women, and has not received the same public awareness as other CVDs.1,2 HF prevalence and mortality are greater among women than men.2
Source: Journal of Cardiac Failure - Category: Cardiology Authors: Tags: Brief Report Source Type: research
FRIDAY, Oct. 18, 2019 -- Longer use of estrogen hormone therapy is associated with higher cognitive status in late life, according to a study published online Oct. 14 in Menopause. Joshua M. Matyi, from Utah State University in Logan, and colleagues...
Source: Drugs.com - Pharma News - Category: Pharmaceuticals Source Type: news
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