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Sexual well-being after menopause: An International Menopause Society White Paper

Simon, J A; Davis, S R; Althof, S E; Chedraui, P; Clayton, A H; Kingsberg, S A; Nappi, R E; Parish, S J; Wolfman, W
Sexual well-being frequently declines following the menopause transition and can be associated with significant personal and relationship distress. This distress is the hallmark of female sexual dysfunction (FSD). FSD is highly prevalent in postmenopausal women. The prevalence of sexual problems increases with age, but conversely this is associated with decreasing distress with advancing age. This pattern has been seen across multiple international populations with varied cultural norms. While the etiology of FSD is multifactorial, the physiological changes of sex hormone insufficiency and postmenopausal symptoms, such as dyspareunia, are primary factors contributing to FSD at midlife. The International Menopause Society is working to increase awareness of FSD and to provide a framework for practitioners to address sexual medicine concerns. This White Paper aims to review the process of care for female sexual well-being following menopause, from initially approaching the discussion of FSD, to identifying clinical signs and symptoms, and ultimately determining the best available biopsychosocial therapies. As with most processes of care, the first step is often the most difficult. Health-care practitioners need to broach the topic of sexuality in the clinical setting. Lack of information on, comfort with, and biases about the topic of sexuality after menopause are significant hurdles that the International Menopause Society addresses in this document. Each member of the Writing Group remains committed to continued advocacy for the validity of FSD as a diagnosis, the need for therapies for women to be both available and included in health insurance coverage, and continued therapeutic research to provide evidence-based solutions.
PMID: 29987939
ISSN: 1473-0804
CID: 3356532

Estradiol vaginal inserts (4 micro g and 10 micro g) for treating moderate to severe vulvar and vaginal atrophy: a review of phase 3 safety, efficacy and pharmacokinetic data

Constantine, G D; Simon, J A; Pickar, J H; Archer, D F; Bernick, B; Graham, S; Mirkin, S
Objective: To review safety, efficacy and pharmacokinetic (PK) data from the phase 3 REJOICE trial, which evaluated a 17beta-estradiol (E2) softgel vaginal insert approved in 2018 for moderate to severe dyspareunia associated with menopausal vulvar and vaginal atrophy (VVA). Methods: REJOICE (Clinicaltrials.gov: NCT02253173) was a randomized, double-blind, placebo-controlled trial in which women with moderate to severe dyspareunia due to menopausal VVA received 4 micro g, 10 micro g or 25 micro g of an E2 vaginal insert or placebo for 12 weeks. The published data for the recently approved 4 micro g and 10 micro g doses of the E2 vaginal insert, including four co-primary efficacy endpoints (change from baseline to week 12 in percentages of superficial and parabasal cells, vaginal pH and severity of dyspareunia), safety and PK (which included serum E2 levels measured by gas chromatography and tandem mass spectrometry), are summarized here. Results: Women were randomized to receive the E2 vaginal insert (4 micro g [n = 186] or 10 micro g [n = 188]; Imvexxya) or placebo (n = 187) in the modified intention-to-treat population. The E2 vaginal insert (4 micro g and 10 micro g) significantly improved the percentages of superficial and parabasal cells (p <.0001), vaginal pH (p <.0001), and the severity score for dyspareunia (p <.05) from baseline to week 12 compared with placebo. The recently approved E2 vaginal insert was well tolerated, with no clinically significant differences in treatment-emergent or serious adverse events versus placebo. Systemic absorption of E2 with both doses was minimal. Conclusions: The recently FDA-approved E2 softgel vaginal insert (4 micro g and 10 micro g) was safe and effective over 12 weeks for treating moderate to severe dyspareunia due to menopausal VVA with minimal systemic E2 levels.
EMBASE:624107118
ISSN: 0300-7995
CID: 3356382

Menopausal hormone therapy for primary prevention: why the USPSTF is wrong

Langer, R D; Simon, J A; Pines, A; Lobo, R A; Hodis, H N; Pickar, J H; Archer, D F; Sarrel, P M; Utian, W H
The US Preventive Services Task Force (USPSTF) Draft Recommendation statement on Menopausal Hormone Therapy: Primary Prevention for Chronic Diseases, released in May 2017, perpetuates a major disconnect between the primary population affected, women within roughly 10 years of menopause, and the data cited. Furthermore, major elements of the evidence relied upon have been misinterpreted or misstated, particularly in regard to coronary heart disease and breast cancer, for which there is no statistically significant evidence of harm. As currently drafted, the recommendations reiterate the USPSTF statements of 2012, 2005 and 2002, and will perpetuate egregious harm to the public health. In an attempt to avoid that outcome and to facilitate a return to rational discourse regarding menopausal hormone therapy, an ad hoc group of experts in menopausal health submitted this comprehensive response to the USPSTF.
PMID: 28805475
ISSN: 1473-0804
CID: 3130682

EFFECT OF FLIBANSERIN ON BODY WEIGHT DURING TREATMENT FOR HYPOACTIVE SEXUAL DESIRE DISORDER IN PREMENOPAUSAL AND POSTMENOPAUSAL WOMEN [Meeting Abstract]

Kornstein, S. G.; Simon, J. A.; Apfel, S. C.; Yuan, J.; Barbour, K. A.; Kissling, R.
ISI:000424038000199
ISSN: 1743-6095
CID: 4212872

Response to "is there overlap in blood-pressure response to the blockers of the renin-angiotensin system between lower and higher renin subjects?" [3] [Letter]

Moran, A; Simon, J A; Pickering, T G; Krauss, R M
EMBASE:351231573
ISSN: 0895-7061
CID: 4240152

Calcium sulfate/PLLA composites for bone regeneration

Chapter by: Mamidwar, S.; Manocchio, J.; Friedman, E.; Simon, J.; Ricci, J. L.; Alexander, H.
in: Transactions - 7th World Biomaterials Congress by
[S.l.] : Soc for Biomaterials St. Louis Park, MN, United States, 2004
pp. 318-?
ISBN: 9781877040191
CID: 2866432

FEA prediction of crestal bone retention around dental implants

Chapter by: Alexander, H.; Weiner, S.; Zweig, B.; Simon, J.; Ricci, J. L.
in: Transactions - 7th World Biomaterials Congress by
[S.l.] : Soc for Biomaterials St. Louis Park, MN, United States, 2004
pp. 52-?
ISBN: 9781877040191
CID: 2866452

Accuracy of the axillary projection to determine fracture angulation of the proximal humerus

Simon, Jordan A; Puopolo, Steven M; Capla, Edward L; Egol, Kenneth A; Zuckerman, Joseph D; Koval, Kenneth J
The accuracy of measuring angulation of stable proximal humerus fractures using the axillary lateral projection was investigated. A closing wedge osteotomy with apex anterior angulation was performed on two cadaveric humeri to simulate a stable surgical neck fracture. One specimen was fixed at 30 degrees angulation and the other at 55 degrees. Axillary radiographs were taken with each specimen articulating with the glenoid of a cadaveric scapula. The humerus was held in neutral rotation. Abduction was set at 30 degrees, 60 degrees, and 90 degrees. In each position of abduction, an axillary lateral radiograph was taken in 30 degrees forward flexion, neutral, and 30 degrees extension to simulate various arm positions. A total of nine radiographs were taken for each specimen. The axillary view is not accurate for measurement of proximal humerus angulation at the arm positions commonly encountered in the trauma setting
PMID: 14992388
ISSN: 0147-7447
CID: 44530

Osseointegration on metallic implant surfaces: effects of microgeometry and growth factor treatment

Frenkel, Sally R; Simon, Jordan; Alexander, Harold; Dennis, Michael; Ricci, John L
Orthopedic implants often loosen due to the invasion of fibrous tissue. The aim of this study was to devise a novel implant surface that would speed healing adjacent to the surface, and create a stable interface for bone integration, by using a chemoattractant for bone precursor cells, and by controlling tissue migration at implant surfaces via specific surface microgeometry design. Experimental surfaces were tested in a canine implantable chamber that simulates the intramedullary bone response around total joint implants. Titanium and alloy surfaces were prepared with specific microgeometries, designed to optimize tissue attachment and control fibrous encapsulation. TGF beta, a mitogen and chemoattractant (Hunziker EB, Rosenberg LC. J Bone Joint Surg Am 1996;78:721-733) for osteoprogenitor cells, was used to recruit progenitor cells to the implant surface and to enhance their proliferation. Calcium sulfate hemihydrate (CS) was the delivery vehicle for TGF beta; CS resorbs rapidly and appears to be osteoconductive. Animals were sacrificed at 6 and 12 weeks postoperatively. Results indicated that TGFbeta can be reliably released in an active form from a calcium sulfate carrier in vivo. The growth factor had a significant effect on bone ingrowth into implant channels at an early time period, although this effect was not seen with higher doses at later periods. Adjustment of dosage should render TGF beta more potent at later time periods. Calcium sulfate treatment without TGF beta resulted in a significant increase in bone ingrowth throughout the 12-week time period studied. Bone response to the microgrooved surfaces was dramatic, causing greater ingrowth in 9 of the 12 experimental conditions. Microgrooves also enhanced the mechanical strength of CS-coated specimens. The grooved surface was able to control the direction of ingrowth. This surface treatment may result in a clinically valuable implant design to induce rapid ingrowth and a strong bone-implant interface, contributing to implant longevity.
PMID: 12418014
ISSN: 0021-9304
CID: 156581

Accuracy of the axillary projection to determine fracture

Simon, J A; Puopolo, S M; Egol, K A; Zuckerman, J D; Koval, K J; Missmer, S A; Spiegelman, D; Yaun, S -S; Adami, H -O; Beeson, W L; Van, Den Brandt P A; Freudenheim, J L; Goldbohm, R A; Kushi, L H; Miller, A B; Potter, J D; Speizer, F E; Toniolo, P; Wolk, A; Zeleniuch-Jacquotte, A; Hunter, D J
Background. More than 20 studies have investigated the relation between meat and dairy consumption and breast cancer risk with conflicting results. Our objective was evaluate the risk of assess whether non-dietary risk factors modify the relation. studies from North America and Western Europe with at least 200 intakes, and a validation study of dietary assessment instrument. diagnosed with invasive breast cancer during to 15 year of intakes of total meat, red me white meat, total dairy fluids, or total dairy solids and breast cancer risk. Categor analyses suggested a J-shaped association for egg consumption where, comp to women who did not eat eggs, breast cancer risk was slightly decreased am women who consumed <2 eggs per week but slightly increased among women who consumed >=1 egg per day. Conclusions. We produ and risk of breast cancer. An inconsistent relation between egg consumption risk of breast cancer merits further investigation
EMBASE:38312658
ISSN: 0300-5771
CID: 4774982