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Sharon J Parish,1 Rossella E Nappi,2 Michael L Krychman,3 Susan Kellogg-Spadt,4 James A Simon,5 Jeffrey A Goldstein,6 Sheryl A Kingsberg7 1Albert Einstein College of Medicine, Bronx, NY, USA; 2Department of Obstetrics and Gynecology, IRCCS Policlinico San Matteo University, University of Pavia, Pavia, Italy; 3Southern California Center for Sexual Health and Survivorship Medicine and Clinical Faculty University of California Irvine, Newport Beach and Irvine, CA, USA; 4Pelvic and Sexual Health Institute, Philadelphia, PA, USA; 5Obstetrics and Gynecology, George Washington University, Washington, DC, USA; 6Novo Nordisk Inc, Princeton, NJ, USA; 7Departments of Reproductive Biology and Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA Abstract: Several recent, large-scale studies have provided valuable insights into patient perspectives on postmenopausal vulvovaginal health. Symptoms of vulvovaginal atrophy, which include dryness, irritation, itching, dysuria, and dyspareunia, can adversely affect interpersonal relationships, quality of life, and sexual function. While approximately half of postmenopausal women report these symptoms, far fewer seek treatment, often because they are uninformed about hypoestrogenic postmenopausal vulvovaginal changes and the availability of safe, effective, and well-tolerated treatments, particularly local vaginal estrogen therapy. Because women hesitate to seek help for symptoms, a proactive approach to conversations about vulvovaginal discomfort would improve diagnosis and treatment. Keywords: health care professional, hypoactive sexual desire disorder, local vaginal estrogen therapy, quality of life, urinary tract infection, vulvovaginal atrophy

BACKGROUND: Video review is a valuable educational tool for teaching communication skills. Many studies have demonstrated its efficacy with individual learners, but few studies have addressed its use in a group format. PURPOSE: To assess the educational benefits of group versus individual video review of standardized patient encounters through the evaluations of 4th-year students at the Albert Einstein College of Medicine. METHODS: Students (128) who participated in a 7-station, standardized patient, clinical competency exam were randomly assigned to an individual or small group video review of selected segments of these encounters in 2000-2001. Students filled out an anonymous 13-item questionnaire assessing the experience and provided open-ended responses. RESULTS: With both review formats, most students had a positive learning experience (80%), found it less stressful than they expected (67%), and would not have preferred to do the review the other way (84%). Students randomized to individual reviews had a significantly higher level of satisfaction with the amount of time for the session (91% vs. 78%, p < .05) and the amount of feedback they received (95% vs. 79%, p = .01) and were more likely to view the session as a positive learning experience (88% vs. 73%, p < .05). Students in the individual review format were more likely to choose self-assessed weak segments (63% vs. 49%, p = .01). Students' comments indicated that they appreciated the value of peer review in a group setting. CONCLUSIONS: Although both group reviews and individual reviews of videotaped standardized patient encounters were received well by the students, there were several statistical differences in favor of the individual format. [ABSTRACT FROM AUTHOR]

Introduction: Prior consensus meetings have addressed the relationship between phosphodiesterase type 5 (PDE5) inhibition and cardiac health. Given significant accumulation of new data in the past decade, a fourth consensus conference on this topic was convened in Pasadena, California, on March 10 and 11, 2023., Objectives: Our meeting aimed to update existing knowledge, assess current guidelines, and make recommendations for future research and practice in this area., Methods: An expert panel reviewed existing research and clinical practice guidelines., Results: Key findings and clinical recommendations are the following: First, erectile dysfunction (ED) is a risk marker and enhancer for cardiovascular (CV) disease. For men with ED and intermediate levels of CV risk, coronary artery calcium (CAC) computed tomography should be considered in addition to previous management algorithms. Second, sexual activity is generally safe for men with ED, although stress testing should still be considered for men with reduced exercise tolerance or ischemia. Third, the safety of PDE5 inhibitor use with concomitant medications was reviewed in depth, particularly concomitant use with nitrates or alpha-blockers. With rare exceptions, PDE5 inhibitors can be safely used in men being treated for hypertension, lower urinary tract symptoms and other common male disorders. Fourth, for men unresponsive to oral therapy or with absolute contraindications for PDE5 inhibitor administration, multiple treatment options can be selected. These were reviewed in depth with clinical recommendations. Fifth, evidence from retrospective studies points strongly toward cardioprotective effects of chronic PDE5-inhibitor use in men. Decreased rates of adverse cardiac outcomes in men taking PDE-5 inhibitors has been consistently reported from multiple studies. Sixth, recommendations were made regarding over-the-counter access and potential risks of dietary supplement adulteration. Seventh, although limited data exist in women, PDE5 inhibitors are generally safe and are being tested for use in multiple new indications., Conclusion: Studies support the overall cardiovascular safety of the PDE5 inhibitors. New indications and applications were reviewed in depth., (© The Author(s) 2024. Published by Oxford University Press on behalf of The International Society of Sexual Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: There are currently no Food and Drug Administration-approved treatments for female sexual arousal disorder (FSAD), which is physiologically analogous to male erectile dysfunction., Aims: The study sought to test the systemic and local genital safety of topical sildenafil cream, 3.6% (sildenafil cream) among healthy premenopausal women with FSAD and their sexual partners over a 12-week treatment period., Methods: This was a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream among healthy premenopausal women with FSAD. Safety was assessed by the frequency and incidence of treatment-emergent adverse events (TEAEs) among participants and their sexual partners. Participants recorded the incidence of TEAEs in a daily eDiary (electronic diary). Sexual partners were contacted within 72 hours of each sexual event in which investigational product was used. All participants used placebo cream for 1 month, during a single-blind run-in period, and then if eligible, were randomized 1:1 to sildenafil cream or placebo cream. Participants used their assigned investigational product over a 12-week double-blind dosing period. They attended monthly follow-up visits, in which their eDiary TEAE data were reviewed by the study staff and graded for severity and relationship to study product., Outcomes: The frequency and incidence of TEAEs among participants and their sexual partners., Results: During the 12-week double-blind dosing period, there were 78 TEAEs reported by 29 of 99 sildenafil-assigned participants and 65 TEAEs reported by 28 of 94 placebo-assigned participants (P = .76). All TEAEs were mild or moderate in severity. The most common treatment-related TEAE among active and placebo-assigned participants was application site discomfort. There were no differences in the number of treatment-related TEAEs among sildenafil cream vs placebo cream users (P > .99). Four sildenafil cream participants and 3 placebo cream participants discontinued the study due to TEAEs involving application site discomfort (P > .99). There were 9 TEAEs reported by 7 of 91 sexual partners exposed to sildenafil cream vs 4 TEAEs reported by 4 of 84 sexual partners exposed to placebo cream (P = .54)., Clinical Implications: These data support further clinical development of topical sildenafil cream for the treatment of FSAD., Strengths and Limitations: Safety was assessed among participants and their sexual partners after 1357 and 1160 sexual experiences in which sildenafil cream or placebo cream were used, respectively. The phase 2b study was powered for the primary objectives of efficacy, rather than safety., Conclusion: These data demonstrate that topically applied sildenafil cream was safe and well tolerated by exposed users and their sexual partners., (© The Author(s) 2024. Published by Oxford University Press on behalf of The International Society of Sexual Medicine.)

The Princeton Consensus (Expert Panel) Conference is a multispecialty collaborative symposium dedicated to optimizing sexual function and preserving cardiovascular health. The Fourth Princeton Consensus Conference was convened on March 10-11, 2023, at the Huntington Medical Research Institutes in Pasadena, California. Princeton panels I to III addressed the clinical management of men with erectile dysfunction (ED) who also had cardiovascular disease. Thirteen years since Princeton III, Princeton IV builds on previous foundations in several key areas. Mounting evidence supports the need for providers to treat men with ED as being at risk for cardiac events until proven otherwise. Algorithms for the diagnosis and treatment of ED are updated with new recommendations for coronary artery calcium scoring for advanced cardiovascular risk stratification. Optimization of oral phosphodiesterase type 5 inhibitors in the treatment of men with ED and cardiovascular disease is thoroughly explored, including recent evidence of potential cardioprotective effects of these drugs., (Copyright © 2024 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

Female sexual dysfunction is highly prevalent, affecting 30% to 50% of cisgender women globally. Low sexual desire, sexual arousal disorder, and orgasm disorder affect 10% to 20%, 6% to 20%, and 4% to 14% of women, respectively. Dyspareunia or pain with intercourse affects 8% to 22% of women. Universal screening is recommended; and a thorough medical history and physical examination are the foundations of evaluation and assessment. Laboratory tests and imaging are sometimes warranted, but referral to a sexual medicine expert is suggested if the practitioner is unfamiliar or uncomfortable with treatment., Competing Interests: Disclosure S.J. Parish serves as a consultant for Dare Bioscience and received no funding for this article. R. Pope serves as a speaker for Astellas, a consultant for Johnson and Johnson Global Public Health, Materna MD, Mim, and Stardust, and received no funding for this article., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: In 1999, 1 year after the approval of the first oral phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED), the first Princeton Consensus Conference was held to address the clinical management of men with ED who also had cardiovascular disease. These issues were readdressed in the second and third conferences. In the 13 years since the last Princeton Consensus Conference, the experience with PDE5 inhibitors is more robust, and recent new data have emerged regarding not only safety and drug-drug interactions, but also a potential cardioprotective effect of these drugs., Aim: In March 2023, an interdisciplinary group of scientists and practitioners met for the fourth Princeton Consensus Guidelines at the Huntington Medical Research Institutes in Pasadena, California, to readdress the cardiovascular workup of men presenting with ED as well as the approach to treatment of ED in men with known cardiovascular disease., Method: A series of lectures from experts in the field followed by Delphi-type discussions were developed to reach consensus., Outcomes: Consensus was reached regarding a number of issues related to erectile dysfunction and the interaction with cardiovascular health and phosphodiesterase-5 inhibitors., Results: An algorithm based on recent recommendations of the American College of Cardiology and American Heart Association, including the use of computed tomography coronary artery calcium scoring, was integrated into the evaluation of men presenting with ED. Additionally, the issue of nitrate use was further considered in an algorithm regarding the treatment of ED patients with coronary artery disease. Other topics included the psychological effect of ED and the benefits of treating it; the mechanism of action of the PDE5 inhibitors; drug-drug interactions; optimizing use of a PDE5 inhibitors; rare adverse events; potential cardiovascular benefits observed in recent retrospective studies; adulteration of dietary supplements with PDE5 inhibitors; the pros and cons of over-the-counter PDE5 inhibitors; non-PDE5 inhibitor therapy for ED including restorative therapies such as stem cells, platelet-rich plasma, and shock therapy; other non-PDE5 inhibitor therapies, including injection therapy and penile prostheses; the issue of safety and effectiveness of PDE5 inhibitors in women; and recommendations for future studies in the field of sexual dysfunction and PDE5 inhibitor use were discussed., Clinical Implications: Algorithms and tables were developed to help guide the clinician in dealing with the interaction of ED and cardiovascular risk and disease., Strengths and Limitations: Strengths include the expertise of the participants and consensus recommendations. Limitations included that participants were from the United States only for this particular meeting., Conclusion: The issue of the intersection between cardiovascular health and sexual health remains an important topic with new studies suggesting the cardiovascular safety of PDE5 inhibitors., (© The Author(s) 2023. Published by Oxford University Press on behalf of The International Society of Sexual Medicine.)

Testosterone is an important evidence-based therapy for hypoactive sexual desire disorder (HSDD) in postmenopausal women. Clinical practice guidelines based on the most comprehensive meta-analysis of benefits and risks of testosterone therapy to date state that the sole evidence-based indication for testosterone therapy is HSDD in postmenopausal women. The guidelines also provide recommendations regarding identification of patients, dosing, monitoring, and follow-up. This Practice Pearl will discuss evidence-based testosterone therapy for management of HSDD in postmenopausal women., (Copyright © 2023 by The North American Menopause Society.)

Background: Approximately 26% of adult women in the United States suffer from female sexual arousal disorder (FSAD), yet little has been done to compare the experience of FSAD in pre- and postmenopausal women, which is critical to enhance the current understanding of FSAD and inform the development and assessment of treatment options for these patient populations., Aim: To explore the experience of condition-associated symptoms and the relative importance of FSAD symptoms, including their severity, bother, and impact, on participants' health-related quality of life (HRQoL) in pre- and postmenopausal women with FSAD., Methods: In-depth, qualitative, semistructured concept elicitation interviews were conducted with premenopausal (n = 23) and postmenopausal (n = 13) women who were clinically diagnosed with FSAD by a trained sexual medicine clinician. All interviews were audio recorded and transcribed verbatim by a professional transcription company. Thematic analysis was performed with the assistance of NVivo qualitative analysis software., Outcomes: Outcomes included qualitative interview data about FSAD symptoms and HRQoL, as well as a comparison between pre- and postmenopausal populations., Results: The most frequently reported symptom in both cohorts was "inability or difficulty with orgasm" (premenopausal, n = 21; postmenopausal, n = 13). The symptom that premenopausal women most desired to have treated was lubrication, and for postmenopausal women, it was a lack of lubrication or wetness and loss of feeling/sensation. In total, 21 of 23 premenopausal women and all 13 postmenopausal women reported a lack of feeling or sensation in the genitals. The most frequently reported HRQoL impact in both groups was decreased confidence., Clinical Implications: Results from this study suggest that the manifestation and experience of FSAD are similar in pre- and postmenopausal women and that the unmet need for an FSAD treatment in the postmenopausal population is just as great as that of the premenopausal population., Strengths and Limitations: This study involved in-depth qualitative interviews with a relatively small group of women (N = 36) recruited from only 5 study sites across the United States., Conclusion: The analysis of qualitative data from the concept elicitation interviews revealed a substantial physical and emotional burden of FSAD, underscoring the need for Food and Drug Administration-approved treatment options for pre- and postmenopausal women with FSAD., (© The Author(s) 2023. Published by Oxford University Press on behalf of The International Society of Sexual Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Aim: To provide a clinical practice guideline for the use of testosterone including identification of patients, laboratory testing, dosing, post-treatment monitoring, and follow-up care in women with hypoactive sexual desire disorder (HSDD)., Methods: The International Society for the Study of Women's Sexual Health appointed a multidisciplinary panel of experts who performed a literature review of original research, meta-analyses, review papers, and consensus guidelines regarding testosterone use in women. Consensus was reached using a modified Delphi method., Outcomes: A clinically useful guideline following a biopsychosocial assessment and treatment approach for the safe and efficacious use of testosterone in women with HSDD was developed including measurement, indications, formulations, prescribing, dosing, monitoring, and follow-up., Results: Although the Global Position Statement endorses testosterone therapy for only postmenopausal women, limited data also support the use in late reproductive age premenopausal women, consistent with the International Society for the Study of Women's Sexual Health Process of Care for the Management of HSDD. Systemic transdermal testosterone is recommended for women with HSDD not primarily related to modifiable factors or comorbidities such as relationship or mental health problems. Current available research supports a moderate therapeutic benefit. Safety data show no serious adverse events with physiologic testosterone use, but long-term safety has not been established. Before initiation of therapy, clinicians should provide an informed consent. Shared decision-making involves a comprehensive discussion of off-label use, as well as benefits and risks. A total testosterone level should not be used to diagnose HSDD, but as a baseline for monitoring. Government-approved transdermal male formulations can be used cautiously with dosing appropriate for women. Patients should be assessed for signs of androgen excess and total testosterone levels monitored to maintain concentrations in the physiologic premenopausal range. Compounded products cannot be recommended because of the lack of efficacy and safety data., Clinical Implications: This clinical practice guideline provides standards for safely prescribing testosterone to women with HSDD, including identification of appropriate patients, dosing, and monitoring., Strengths and Limitations: This evidence-based guideline builds on a recently published comprehensive meta-analysis and the Global Position Statement endorsed by numerous societies. The limitation is that testosterone therapy is not approved for women by most regulatory agencies, thereby making prescribing and proper dosing challenging., Conclusion: Despite substantial evidence regarding safety, efficacy, and clinical use, access to testosterone therapy for the treatment of HSDD in women remains a significant unmet need.

In May of 2020, the Substance Abuse and Mental Health Service Administration (SAMSA) issued guidelines for state psychiatric hospitals, recommending that these facilities adopt universal testing for COVID-19 and "three-space" triage protocols for dedicated COVID-19 positive, negative, and quarantine spaces to mitigate the risk of nosocomial infection. The Westchester Behavioral Health Center of New York Presbyterian Hospital (WBHC-NYP) adopted a comprehensive infection control protocol consistent with these recommendations in April, 2020. We reviewed the records of 1,139 patients treated on the inpatient service at WBHC-NYP between March 14th and June 10 th , 2020, dates corresponding to the first COVID-19 surge in the New York City metropolitan region. The incidence of detected nosocomial or possible nosocomial infections before and during the implementation of the protocol was 0.096 (16/167), or 0.96 infections per 10 at-risk patients. The incidence of nosocomial or possible nosocomial infections after complete implementation was 0.0110 (2/182), or 1.1 infections per 100 at-risk patients. The difference in incidence between the two time points was statistically significant (p<.0003) and represents a 9-fold decrease.  Our findings support the institutional use of a combined testing and space allocation protocol to mitigate risk of outbreaks in confined settings., (Copyright © 2021. Published by Elsevier B.V.)

The coronavirus disease 2019 (COVID-19) pandemic presented unprecedented challenges to the provision of inpatient psychiatric care. The nature of the physical plant, programmatic constraints, and the patient population required a rapid and agile approach to problem-solving under conditions of uncertainty and stress. Flexibility in decision-making, excellent communication, an effective working relationship with infection prevention and control experts, and attention to staff morale and support were important elements of successful provision of care to our inpatients. We present our experience, lessons learned, and recommendations should a resurgence of the pandemic or a similar crisis occur., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Some psychiatric hospitals have instituted mandatory COVID-19 testing for all patients referred for admission. Others have permitted patients to decline testing. Little is known about the rate of COVID-19 infection in acute psychiatric inpatients. Characterizing the proportion of infected patients who have an asymptomatic presentation will help inform policy regarding universal mandatory versus symptom-based or opt-out testing protocols. We determined the COVID-19 infection rate and frequency of asymptomatic presentation in 683 consecutively admitted patients during the surge in the New York City region between April 3rd, 2020 and June 8th, 2020. Among these psychiatric inpatients, there was a 9.8 % overall rate of COVID-19 infection. Of the COVID-19 infected patients, approximately 76.1 % (51/67) either had no COVID-19 symptoms or could not offer reliable history of symptoms at the time of admission. Had they not been identified by testing and triaged to a COVID-19 positive unit, they could have infected others, leading to institutional outbreak. These findings provide justification for psychiatric facilities to maintain universal mandatory testing policies, at least until community infection rates fall and remain at very low levels., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background: Persistent genital arousal disorder (PGAD), a condition of unwanted, unremitting sensations of genital arousal, is associated with a significant, negative psychosocial impact that may include emotional lability, catastrophization, and suicidal ideation. Despite being first reported in 2001, PGAD remains poorly understood., Aim: To characterize this complex condition more accurately, review the epidemiology and pathophysiology, and provide new nomenclature and guidance for evidence-based management., Methods: A panel of experts reviewed pertinent literature, discussed research and clinical experience, and used a modified Delphi method to reach consensus concerning nomenclature, etiology, and associated factors. Levels of evidence and grades of recommendation were assigned for diagnosis and treatment., Outcomes: The nomenclature of PGAD was broadened to include genito-pelvic dysesthesia (GPD), and a new biopsychosocial diagnostic and treatment algorithm for PGAD/GPD was developed., Results: The panel recognized that the term PGAD does not fully characterize the constellation of GPD symptoms experienced by patients. Therefore, the more inclusive term PGAD/GPD was adopted, which maintains the primacy of the distressing arousal symptoms and acknowledges associated bothersome GPD. While there are diverse biopsychosocial contributors, there is a common underlying neurologic basis attributable to spontaneous intense activity of the genito-pelvic region represented in the somatosensory cortex and its projections. A process of care diagnostic and treatment strategy was developed to guide the clinician, whenever possible, by localizing the symptoms as originating in any of five regions: (i) end organ, (ii) pelvis/perineum, (iii) cauda equina, (iv) spinal cord, and (v) brain. Psychological treatment strategies were considered critical and should be performed in conjunction with medical strategies. Pharmaceutical interventions may be used based on their site and mechanism of action to reduce patients' symptoms and the associated bother and distress., Clinical Implications: The process of care for PGAD/GPD uses a personalized, biopsychosocial approach for diagnosis and treatment., Strengths and Limitations: Strengths and Limitations: Strengths include characterization of the condition by consensus, analysis, and recommendation of a new nomenclature and a rational basis for diagnosis and treatment. Future investigations into etiology and treatment outcomes are recommended. The main limitations are the dearth of knowledge concerning this condition and that the current literature consists primarily of case reports and expert opinion., Conclusion: We provide, for the first time, an expert consensus review of the epidemiology and pathophysiology and the development of a new nomenclature and rational algorithm for management of this extremely distressing sexual health condition that may be more prevalent than previously recognized. Goldstein I, Komisaruk BR, Pukall CF, et al. International Society for the Study of Women's Sexual Health (ISSWSH) Review of Epidemiology and Pathophysiology, and a Consensus Nomenclature and Process of Care for the Management of Persistent Genital Arousal Disorder/Genito-Pelvic Dysesthesia (PGAD/GPD). J Sex Med 2021;18:665-697., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: The 2 most well-known classification systems that include sexual medicine diagnoses are the International Classification of Diseases and Statistics (ICD) and the Diagnostic and Statistical Manual of Mental Disorders (DSM). Sexual medicine experts from international societies representing an array of disciplines have revised and redefined female sexual dysfunctions (FSDs) to reflect current scientific evidence and the state of the art., Aim: To summarize the evidence and interactive and chronological process by which sexual medicine societies' consensus groups developed the current nomenclature, classifications, and definitions for FSDs., Methods: We review the contributions and collaborations of the Fourth International Consultation in Sexual Medicine (ICSM), the International Society for the Study of Women's Sexual Health (ISSWSH), and the World Association of Sexual Health in conjunction with the World Health Organization., Main Outcome Measures: The ICSM and ISSWSH diagnostic systems are contrasted with the DSM classification. We discuss innovations and strengths; relevant evidence regarding epidemiology, etiology, and risk factors; and key differences. We describe how sexual medicine expertise informed FSD codes in the ICD-11 classification., Results: ICSM and ISSWSH published evidence-based guidelines on the definitions, nomenclature, and diagnostic criteria for FSD that diverge from the DSM psychiatric compendia. These definitions and nomenclature recommend the separation of female sexual desire and arousal disorders, elaborate on subtypes of arousal problems, broaden the scope of sexual pain definitions, and provide a greater understanding of etiologies and risk factors for FSDs., Conclusions: These collaborations among sexual medicine experts and their role in the ICD-11 development process provide confidence that the ICD-11 Sexual Dysfunction codes are based on current scientific evidence for diagnosing and coding FSDs in clinical settings worldwide, can serve as endpoints in clinical trials, and will provide specificity for treatment outcomes for FSD therapies. Parish SJ, Cottler-Casanova S, Clayton AH, et al. The Evolution of the Female Sexual Disorder/Dysfunction Definitions, Nomenclature, and Classifications: A Review of DSM, ICSM, ISSWSH, and ICD. Sex Med 2021;9:36-56., (Copyright © 2020 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Psychiatric patients are at high risk for contracting COVID-19, and inpatient psychiatric units face substantial risks of institutional outbreaks. Here, the authors describe an algorithm for testing and triage in a large psychiatric facility designed to prevent local COVID-19 transmission. The algorithm is based on expert opinion and clinical experience between March and April of 2020, during which the institution cared for 47 COVID-19 positive psychiatric inpatients. The implementation of the algorithm is designed to mitigate COVID-19 transmission, preserve the safest and least restrictive treatment environment for psychiatric inpatients, and provide a model adaptable to other institutional settings., Competing Interests: Declaration of Competing Interest None of the authors report any grant support, other external funding, or other conflicts of interest., (Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.)

Introduction: Flibanserin is approved in the United States and Canada for the treatment of hypoactive sexual desire disorder in premenopausal women., Aim: The purpose of this trial was to evaluate the safety of concomitant administration of flibanserin with alcohol., Methods: In this single-center, randomized, double-blind, single-dose, crossover study, participants were randomly assigned to 1 of 12 sequences to receive each of 7 treatments: flibanserin 100 mg or placebo with ethanol 0.2 g/kg, 0.4 g/kg, or 0.6 g/kg, or flibanserin 100 mg only. Treatments were administered using a worst-case approach that included morning dosing and consumption of alcohol within 10 minutes., Main Outcome Measure: The primary end point was the proportion of participants who experienced dizziness, syncope, or hypotension. Safety end points included orthostatic vital signs., Results: The study included 96 premenopausal women (mean age 31 ± 8 years). The incidence of dizziness for ethanol + flibanserin was 39.8% for ethanol 0.6 g/kg, 34.1% for 0.4 g/kg, and 27.4% for 0.2 g/kg compared with 31.1% for flibanserin without ethanol. Based on the available vital signs data, there was no effect of ethanol concentration on orthostatic blood pressure, vertigo, or hypotension; no instances of syncope were observed. The overall incidence of adverse events (AEs) was similar when flibanserin was administered alone (96.7%) or with ethanol (90.5-97.6%)., Clinical Implications: Consumption of the tested amounts of alcohol (0.2-0.6 g/kg) does not have an additive effect on the AE profile of flibanserin 100 mg in healthy premenopausal women., Strengths & Limitations: Strengths include the study population (premenopausal women, as indicated for flibanserin) and range of ethanol doses. Limitations include the morning dosing of study medication, which is inconsistent with the bedtime dosing recommended for flibanserin, and the method of handling missing vital sign measurements., Conclusion: Co-administration of flibanserin 100 mg with varying doses of ethanol resulted in few AEs of special interest, with no notable alcohol dose response. However, a significantly greater percentage of participants administered flibanserin with 0.6 g/kg and 0.4 g/kg of alcohol were characterized as "Participants in Whom Standing Blood Pressure Was Not Obtained" compared with participants administered flibanserin alone. Simon JA, Clayton AH, Parish SJ, et al. Effects of Alcohol Administered With Flibanserin in Healthy Premenopausal Women: A Randomized, Double-Blind, Single-Dose Crossover Study. J Sex Med 2020;17:83-93., (Copyright © 2019. Published by Elsevier Inc.)

Introduction: Flibanserin, a treatment for hypoactive sexual desire disorder, carries warnings for increased risk of severe hypotension and syncope when used with alcohol. However, these warnings are not informed by studies that used flibanserin's recommended bedtime dosing because previous alcohol studies assessed flibanserin's safety during the day., Aim: The aim of this study was to assess the effects of ethanol in a real-world context in premenopausal women taking flibanserin at bedtime., Methods: In a randomized, placebo-controlled, double-blind study, 24 healthy premenopausal women (mean age = 34.5 ± 9.9 years; mean body mass index = 25.2 ± 3.4 kg/m 2 ) were dosed with flibanserin or placebo for 3 days to achieve steady-state plasma levels. In a clinical research unit, subjects (n = 22) were provided 2 units of wine (150 mL/unit; 12% ethanol content) or a nonalcoholic beverage with a standardized 3-course evening meal. Flibanserin 100 mg or placebo was administered at bedtime 2.5 hours after the end of the evening meal. On a separate day, subjects were provided the alternative beverage (± alcohol) with the same evening meal and dosed with the same treatment (flibanserin or placebo) at bedtime. After a 5-day washout period, subjects crossed over to the other treatment arm and the protocol was repeated., Main Outcome Measure: Adverse events (AEs) and vital signs were monitored., Results: In the absence of ethanol, headaches and hypotension were the only AEs that occurred in ≥2 subjects after flibanserin dosing (placebo corrected rates were 17.4% and 8.7%, respectively). After ethanol consumption, the rate of hypotension after flibanserin dosing was no greater than with flibanserin or placebo after nonalcoholic beverage consumption. There were no instances of orthostatic hypotension or syncope and no serious AEs or AEs leading to study discontinuation., Conclusion: Flibanserin dosed at bedtime after moderate amounts of alcohol with an evening meal was well-tolerated with no evidence of clinically significant hypotension or syncope. Millheiser L, Clayton AH, Parish SJ, et al. Safety and Tolerability of Evening Ethanol Consumption and Bedtime Administration of Flibanserin in Healthy Premenopausal Female Subjects. Sex Med 2019;7:418-424., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: The softgel 17β-estradiol (E2) vaginal inserts (4 and 10 μg; Imvexxy; TherapeuticsMD, Boca Raton, FL) are FDA approved for treating moderate to severe dyspareunia associated with postmenopausal vulvar and vaginal atrophy (VVA). The objective here was to determine responder rates at week 2 and whether week-2 findings predicted week-12 responders in the REJOICE trial., Methods: Postmenopausal women received E2 vaginal inserts 4, 10, or 25 μg, or placebo for 12 weeks. Proportion of responders (having ≥2 of the following: vaginal superficial cells >5%, vaginal pH <5.0, or dyspareunia improvement of ≥1 category) were calculated. Odds ratios (ORs) for positive response at week 12 given a positive response at week 2 were determined in the efficacy evaluable (EE) population., Results: The responder rate (in EE population [n = 695]) was 74% to 82% with E2 inserts versus 24% with placebo at week 2, and 72% to 80% versus 33% at week 12. Positive treatment responses were 9- to 14-fold higher with vaginal E2 than with placebo at week 2, and 5- to 8-fold higher at week 12. Response at week 2 predicted response at week 12 in the total population (OR 13.1; 95% CI, 8.8-19.7) and with active treatment only (OR 7.9; 95% CI, 4.7-13.2)., Conclusions: A high percentage of postmenopausal women with moderate to severe dyspareunia responded with the E2 softgel vaginal insert at week 2, and a positive response at week 2 predicted a positive response at week 12.

Introduction: Flibanserin is approved in the United States and Canada for the treatment of acquired, generalized, hypoactive sexual desire disorder in premenopausal women. Sedation-related side effects are among the most prevalent adverse events. Although infrequent, hypotension and syncope remain safety concerns because of possible interaction of flibanserin with alcohol., Aim: To evaluate the impact of the timing of alcohol consumption on flibanserin safety and tolerability., Methods: In this single-center, randomized, double-blind, placebo-controlled, 4-treatment crossover study, 64 healthy premenopausal women (mean age 32.5 ± 8.7 years; range 20‒52 years) received once-daily flibanserin 100 mg or placebo during each of two 10-day treatment periods. Study medication was administered on days 1-3 to achieve steady state. On days 4, 6, 8, and 10, after a standard breakfast, participants consumed 0.4 g/kg ethanol (approximately equivalent to two 5-oz glasses of wine) administered with orange juice 2, 4, or 6 hours before taking study medication or orange juice alone (no ethanol) 2 hours before taking study medication., Outcomes: The primary endpoint was percentage of participants experiencing syncope or orthostatic hypotension-associated adverse events requiring medical intervention. Secondary endpoints included the incidence of hypotension, the incidence of orthostatic hypotension, and rates of adverse events of special interest (syncope, orthostatic hypotension, dizziness, and somnolence)., Results: 1 participant experienced a primary endpoint event (syncope) during treatment with placebo taken 4 hours after ethanol consumption. Within each ethanol dose-timing treatment, there were no statistically significant differences for flibanserin compared with placebo. Rates of hypotension were 53.3-66.7% after flibanserin dosing and 57.4-63.3% after placebo dosing. Rates for orthostatic hypotension were 0.0-5.0% after flibanserin dosing and 1.7-6.6% after placebo dosing., Clinical Implications: Ethanol interaction with flibanserin was not observed in this study., Strengths & Limitations: This study provides information regarding the use of flibanserin after the consumption of moderate amounts of ethanol (0.4 g/kg). However, daytime administration of flibanserin is not consistent with the drug's indicated bedtime dosing., Conclusion: Flibanserin, at steady state taken 2, 4, or 6 hours after 0.4 g/kg of ethanol intake did not increase the incidence of hypotension, orthostatic hypotension, or syncope compared with either flibanserin alone or ethanol alone. Simon JA, Clayton AH, Kingsberg SA, et al. Effects of Timing of Flibanserin Administration Relative to Alcohol Intake in Healthy Premenopausal Women: A Randomized, Double-Blind, Crossover Study. J Sex Med 2019;16:1779-1786., (Copyright © 2019 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: The perceptions and attitudes of menopause shared by men are largely unknown. This analysis characterized men's awareness and their understanding of their partner's menopausal transition., Methods: A 35-question, online survey was used to assess men's perceptions and attitudes toward menopause. Men were recruited from an online research marketplace and were eligible to participate if their female partners (45-64 years old) experienced ≥1 of the following symptoms: hot flashes, night sweats, sleepless nights, difficulty sleeping, low libido, mood swings, pain during sex, or vaginal dryness. Couples either lived together full time, or, if living separately, resided together regularly two or more times a week., Results: Of the 1,356 surveys sent to eligible men, 450 (33%) were completed. Most men were between 50 and 69 years (80%), married and not separated (90%), and lived with their partner full time (97%). Men were aware of the symptoms regularly experienced by their partner, with difficulty sleeping (54%) and lack of energy (49%) being frequently identified; these symptoms were attributed to menopause (26%) and/or aging (22%). Of those who were affected by symptoms (63%), most men reported they negatively impacted them (77%), their partners (70%), and relationships (56%). Men engaged in discussions with their partners regarding menopausal symptoms (72%) and believed they were somewhat/very influential (75%) in their partner's decision to seek treatment or make lifestyle adjustments., Conclusions: Overall, men are aware of their partner's menopausal transition and may influence decisions relating to symptom management. Educational interventions would further benefit men's awareness of menopause and available treatment options.Video Summary:http://links.lww.com/MENO/A424.

Genitourinary syndrome of menopause is a condition comprising the atrophic symptoms and signs women may experience in the vulvovaginal and bladder-urethral areas as a result of the loss of sex steroids that occurs with menopause. It is a progressive condition that does not resolve without treatment and can adversely affect a woman's quality of life. For a variety of reasons, many symptomatic women do not seek treatment and, of those who do, many are unhappy with their options. Additionally, many healthcare providers do not actively screen their menopausal patients for the symptoms of genitourinary syndrome of menopause. In this review, we discuss the clinical presentation of genitourinary syndrome of menopause as well as the treatment guidelines recommended by the major societies engaged in women's health. This is followed by a review of available treatment options that includes both hormonal and non-hormonal therapies. We discuss both the systemic and vaginal estrogen products that have been available for decades and remain important treatment options for patients; however, a major intent of the review is to provide information on the newer, non-estrogen pharmacologic treatment options, in particular oral ospemifene and vaginal prasterone. A discussion of adjunctive therapies such as moisturizers, lubricants, physical therapy/dilators, hyaluronic acid, and laser therapy is included. We also address some of the available data on both the patient and healthcare providers perspectives on treatment, including cost, and touch briefly on the topic of treating women with a history of, or at high risk for, breast cancer.

Background: An association between erectile dysfunction (ED) and cardiovascular (CV) disease (CVD) has long been recognized, and studies suggest that ED is an independent marker of CVD risk. More significantly, ED is a marker for both obstructive and non-obstructive coronary artery disease (CAD) and may reveal the presence of subclinical CAD in otherwise asymptomatic men., Aim: To discuss the role of ED as an early marker of subclinical CVD; describe an approach to quantifying that burden; and propose an algorithm for the evaluation and management of CV risk in men 40-60 years of age with vasculogenic ED, those presumed to have the highest risk for a CV event., Methods: A comprehensive review of original literature and expert consensus documents was conducted and incorporated into clinical recommendations for ED management in the context of CV risk., Outcomes: Assessment and management of ED may help identify and reduce the risk of future CV events. Initial evaluation should distinguish between vasculogenic ED and ED of other etiologies., Results: For men with predominantly vasculogenic ED, we recommend that initial CV risk stratification be based on the 2013 American College of Cardiology/American Heart Association atherosclerotic CV disease risk score. Management of men with ED who are at low risk for CVD should focus on risk factor control; men at high risk, including those with CV symptoms, should be referred to a cardiologist. Intermediate-risk men should undergo non-invasive evaluation for subclinical atherosclerosis. Evidence supports use of a prognostic markers, particularly coronary calcium score, to further understand CV risk in men with ED., Conclusions: Clinicians must assess the presence or absence of ED in every man >40 years of age, especially those men who are asymptomatic for signs and symptoms of CAD. We support CV risk stratification and CVD risk factor reduction in all men with vasculogenic ED. Miner M, Parish SJ, Billups KL, et al. Erectile Dysfunction and Subclinical Cardiovascular Disease. Sex Med Rev 2018;7:455-463., (Copyright © 2018 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Sexual problems are common in women of all ages. Despite their frequency and impact, female sexual dysfunctions (FSDs) are often unrecognized and untreated in clinical settings. In response, the International Society for the Study of Women's Sexual Health convened a multidisciplinary, international expert panel to develop a process of care (POC) that outlines recommendations for identification of sexual problems in women. This POC describes core and advanced competencies in FSD for clinicians who are not sexual medicine specialists and serve as caregivers of women and, therefore, is useful for clinicians with any level of competence in sexual medicine. The POC begins with the expectation of universal screening for sexual concerns, proceeds with a 4-step model (eliciting the story, naming/reframing attention to the problem, empathic witnessing of the patient's distress and the problem's impact, and referral or assessment and treatment) that accommodates all levels of engagement, and delineates a process for referral when patients' needs exceed clinician expertise. Distressing problems related to desire, arousal, and orgasm affect 12% of women across the lifespan. Low desire is the most common sexual problem, but sexual pain and other less common disorders of arousal and orgasm are also seen in clinical practice. Screening is best initiated by a ubiquity statement that assures the patient that sexual concerns are common and can be revealed. Patient-centered communication skills facilitate and optimize the discussion. The goal of the POC is to provide guidance to clinicians regarding screening, education, management, and referral for women with sexual problems., (Copyright © 2019 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

Background: Although sexual health can be considered a vital sign for overall health, several barriers prevent women from receiving proper medical counseling, support, and/or care for their sexual health needs and concerns., Methods: Experts in sexual health compiled research and experience on the impediments to women receiving adequate assessment and treatment for their sexual health. Specific solutions and a roadmap for overcoming such barriers and improving patient-clinician communication are presented., Results: Social stigma around female sexuality remains in Western culture and as a result, women often avoid and/or are embarrassed to discuss their sexual health with their health care professionals (HCPs). Moreover, midlife women are typically unaware or have misconceptions about conditions that may adversely impact their sexual life, such as genitourinary syndrome of menopause and hypoactive sexual desire disorder. Without understanding there may be underlying medical conditions, there is also a lack of awareness that safe and effective treatments are available. Lack of training, tools, time, and limited treatment options impede HCPs from providing women with necessary sexual health support. Educating women, training HCPs, and providing communication tools to HCPs can facilitate effective dialog between patients and HCPs. More specifically, HCPs can be trained to initiate and maintain a sexual health conversation in a manner that is comfortable for women to convey sexual health needs and concerns, and for HCPs to correctly identify, diagnose, and treat the sexual problems of their female patients., Conclusions: Solutions exist to address the barriers currently impeding patient-clinician interactions around sexual health.

Objectives: Three scientific societies, the International Society for the Study of Vulvovaginal Disease (ISSVD), the International Society for the Study of Women Sexual Health (ISSWSH), and the International Pelvic Pain Society (IPPS) developed the "2015 ISSVD, ISSWSH, and IPPS Consensus Terminology and Classification of Persistent Vulvar Pain and Vulvodynia" (referred to as the "2015 consensus terminology").The terminology included 11 descriptors of vulvodynia. However, the definitions of the descriptors were not included in the 2015 consensus terminology publications. The objective of this article was to provide these definitions., Materials and Methods: The ISSVD led a discussion on the definitions for the 11 vulvodynia descriptors, with participation from the ISSWSH and IPPS. The definitions were created through a consensus process., Results: The definitions are described and the rationale for their choice is elucidated., Conclusions: The definitions of vulvodynia descriptors were determined by a multistaged process of discussion among health care providers with expertise in the pathophysiology, evaluation, and treatment of vulvodynia. The definitions were approved by the ISSVD, ISSWSH, and IPPS. It is recommended that these definitions of vulvodynia descriptors as well as the 2015 consensus terminology be used for the classification of vulvodynia.

Introduction: In 2016 the International Society for the Study of Women's Sexual Health (ISSWSH) published an expert consensus report on new nomenclature that addressed the need for comprehensive, evidence-based criteria for new diagnoses in desire, arousal, and orgasm, with the definition on arousal focusing exclusively on female genital arousal disorder (FGAD)., Aim: A new expert panel solely focused on mechanisms of arousal disorders convened to revise the nomenclature to include female cognitive arousal disorder (FCAD) and FGAD., Methods: The ISSWSH co-chairs identified experts on arousal disorders in women. The 10 participants included clinicians, researchers, and educators, representing a diverse, multidisciplinary group. Pre-meeting preparation included evidence-based literature review as the basis of presentations panelists made at the meeting on the current knowledge in cognitive arousal. Consensus was reached using a modified Delphi method. Writing assignments were made as a basis of manuscript development., Main Outcome Measures: The new definition of FCAD is characterized by distressing difficulty or inability to attain or maintain adequate mental excitement associated with sexual activity, as manifested by problems with feeling engaged and mentally turned on or sexually aroused for a minimum of 6 months., Results: Female sexual arousal disorder encompasses both FGAD (revised definition) and FCAD (new definition). Recommendations regarding diagnosis include a clinical interview to assess for FCAD using targeted questions. Patient-reported outcomes that contain questions to assess FCAD are described, including limitations for differentiating between cognitive arousal, genital arousal, and sexual desire. Laboratory measures of cognitive and genital arousal are discussed, including the relationships between genital and cognitive arousal patterns. Biopsychosocial risk factors for FCAD and FGAD, as well as exclusionary conditions, are presented., Clinical Implications: The revision of the ISSWSH nomenclature regarding the criteria for the 2 arousal categories, FCAD and FGAD, and the recommended diagnostic strategies offers a framework for management of women with arousal disorders., Strengths & Limitations: This nomenclature allows for basic science and clinical research in subtypes of arousal in order to develop better diagnostic and treatment options for use by clinicians, scientists, and regulatory agencies. There are limited validated measures of cognitive arousal, including the Female Sexual Function Index, the most commonly used measure, which does not effectively distinguish between cognitive excitement, genital sensations, and event-related desire., Conclusion: Future directions include the refinement of FCAD and FGAD and development and validation of patient-reported outcomes that distinguish between the cognitive processes and genital responses to enhance clinical care and research in this area. Parish SJ, Meston CM, Althof SE, et al. Toward a More Evidence-Based Nosology and Nomenclature for Female Sexual Dysfunctions-Part III. J Sex Med 2019;16:452-462., (Copyright © 2019 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate and compare physicians' behaviors and attitudes regarding vulvar and vaginal atrophy (VVA) treatment in menopausal women, including women with breast cancer, using an internet-based survey., Methods: The WISDOM survey queried obstetricians and gynecologists (OB/GYNs) and primary care physicians (PCPs) with 23 multipart questions assessing behaviors and attitudes towards VVA treatment., Results: Of 2,424 surveys sent, 945 (39%) responded and 644 (27%) were completed. Of the menopausal women seen by OB/GYNs and PCPs, 44% to 55% reported having VVA symptoms. Physicians prescribed VVA treatments primarily because of effectiveness. Only 34% of OB/GYNs and 17% of PCPs felt comfortable prescribing VVA therapies to women with a personal history of breast cancer. In general, the most common VVA treatment recommended by all was prescription therapy (49%; with or without other therapies) in the form of US Food and Drug Administration-approved vaginal estrogen creams. More OB/GYNs (72%) than PCPs (47%) disagreed that VVA was best treated with over the counter than prescription products. Out-of-pocket cost and fear of risks associated with estrogens were believed to be the main barriers for why women choose not to get treated and why they discontinue treatment., Conclusions: More OB/GYNs than PCPs prescribed VVA treatment, especially vaginal estrogens, for menopausal women, but both groups generally had similar attitudes and behaviors regarding VVA treatment. Physician comfort was low when prescribing to women with a history of breast cancer, despite women's health medical societies supporting vaginal estrogen use in women with a history of estrogen-dependent breast cancer who were unresponsive to nonhormonal therapies when offered in consultation with their oncologist.

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.

Introduction: This article discusses a blueprint for a sexual health communication curriculum to facilitate undergraduate medical student acquisition of sexual history taking skills and includes recommendations for important elements of a thorough sexual history script for undergraduate medical students., Aim: To outline the fundamentals, objectives, content, timing, and teaching methods of a gold standard curriculum in sexual health communication., Methods: Consensus expert opinion was documented at the 2012, 2014, and 2016 Summits in Medical Education in Sexual Health. Additionally, the existing literature was reviewed regarding undergraduate medical education in sexual health., Main Outcome Measures: This article reports expert opinion and a review of the literature on the development of a sexual history taking curriculum., Results: First-year curricula should be focused on acquiring satisfactory basic sexual history taking skills, including both assessment of sexual risk via the 5 Ps (partners, practices, protection from sexually transmitted infections, past history of sexually transmitted infections, and prevention of pregnancy) as well as assessment of sexual wellness-described here as a sixth P (plus), which encompasses the assessment of trauma, violence, sexual satisfaction, sexual health concerns/problems, and support for gender identity and sexual orientation. Second-year curricula should be focused on incorporating improved clinical reasoning, emphasizing sexual history taking for diverse populations and practices, and including the impact of illness on sexual health. Teaching methods must include varied formats. Evaluation may be best as a formative objective structured clinical examination in the first year and summative in the second year. Barriers for curriculum development may be reduced by identifying faculty champions of sexual health/medicine., Clinical Implications: Medical students will improve their skills in sexual history taking, which will ultimately impact patient satisfaction and clinical outcomes. Future research is needed to validate this proposed curriculum and assess the impact on clinical skills., Strengths & Limitations: This article assimilates expert consensus and existing clinical guidelines to provide a novel structured approach to curriculum development in sexual health interviewing in the pre-clinical years., Conclusion: The blueprint for developing sexual history taking skills includes a spiral curriculum with varied teaching formats, incorporation of a sexual history script that incorporates inquiry about sexual wellness, and longitudinal assessment across the pre-clinical years. Ideally, sexual health communication content should be incorporated into existing clinical interviewing and physical examination courses. Rubin ES, Rullo J, Tsai P, et al. Best Practices in North American Pre-Clinical Medical Education in Sexual History Taking: Consensus From the Summits in Medical Education in Sexual Health. J Sex Med 2018;15:1414-1425., (Copyright © 2018 International Society for Sexual Medicine. All rights reserved.)

Objective: This narrative review strives to give healthcare providers (HCPs) who care for menopausal women better tools and skills to initiate discussions with women about menopause and hormone therapy (HT), communicate complex concepts and data, and promote shared decision-making., Methods: We review relevant studies on HT, barriers to treatment of menopausal symptoms, and effective communication strategies. We also provide recommendations for communicating with patients about HT based on the medical literature and our own professional experience., Results: Both patient and HCP-related barriers can prevent women from accessing treatment for bothersome symptoms of menopause. Many women and HCPs have a poor understanding of the complex, nuanced data regarding HT. The benefits and risks vary with patient age and time since menopause, duration of use, inclusion of a progestin, and patient medical history. Women may also have fears about potential side effects of HT and feel unable to make informed choices. Strategies for effective patient communication and shared decision-making include use of open-ended questions to elicit patient's concerns and preferences, reflecting back to the patient what the HCP heard, presenting evidence about benefits and risks in language the patient can understand, keeping risks in perspective (eg, provide absolute, and also relative risks) without minimizing them, and making conscious efforts to minimize potential bias., Conclusions: Necessary components for achieving high-quality, shared decisions about HT involve a combination of medical evidence, communication skills, and recognition of patient goals and concerns. Use of such strategies can enhance women's satisfaction with care.

The objective of The North American Menopause Society (NAMS) and The International Society for the Study of Women's Sexual Health (ISSWSH) Expert Consensus Panel was to create a point of care algorithm for treating genitourinary syndrome of menopause (GSM) in women with or at high risk for breast cancer. The consensus recommendations will assist healthcare providers in managing GSM with a goal of improving the care and quality of life for these women. The Expert Consensus Panel is comprised of a diverse group of 16 multidisciplinary experts well respected in their fields. The panelists individually conducted an evidence-based review of the literature in their respective areas of expertise. They then met to discuss the latest treatment options for genitourinary syndrome of menopause (GSM) in survivors of breast cancer and review management strategies for GSM in women with or at high risk for breast cancer, using a modified Delphi method. This iterative process involved presentations summarizing the current literature, debate, and discussion of divergent opinions concerning GSM assessment and management, leading to the development of consensus recommendations for the clinician.Genitourinary syndrome of menopause is more prevalent in survivors of breast cancer, is commonly undiagnosed and untreated, and may have early onset because of cancer treatments or risk-reducing strategies. The paucity of evidence regarding the safety of vaginal hormone therapies in women with or at high risk for breast cancer has resulted in avoidance of treatment, potentially adversely affecting quality of life and intimate relationships. Factors influencing decision-making regarding treatment for GSM include breast cancer recurrence risk, severity of symptoms, response to prior therapies, and personal preference.We review current evidence for various pharmacologic and nonpharmacologic therapeutic modalities in women with a history of or at high risk for breast cancer and highlight the substantial gaps in the evidence for safe and effective therapies and the need for future research. Treatment of GSM is individualized, with nonhormone treatments generally being first line in this population. The use of local hormone therapies may be an option for some women who fail nonpharmacologic and nonhormone treatments after a discussion of risks and benefits and review with a woman's oncologist. We provide consensus recommendations for an approach to the management of GSM in specific patient populations, including women at high risk for breast cancer, women with estrogen-receptor positive breast cancers, women with triple-negative breast cancers, and women with metastatic disease.

The International Society for the Study of Women's Sexual Health process of care (POC) for management of hypoactive sexual desire disorder (HSDD) algorithm was developed to provide evidence-based guidelines for diagnosis and treatment of HSDD in women by health care professionals. Affecting 10% of adult females, HSDD is associated with negative emotional and psychological states and medical conditions including depression. The algorithm was developed using a modified Delphi method to reach consensus among the 17 international panelists representing multiple disciplines. The POC starts with the health care professional asking about sexual concerns, focusing on issues related to low sexual desire/interest. Diagnosis includes distinguishing between generalized acquired HSDD and other forms of low sexual interest. Biopsychosocial assessment of potentially modifiable factors facilitates initiation of treatment with education, modification of potentially modifiable factors, and, if needed, additional therapeutic intervention: sex therapy, central nervous system agents, and hormonal therapy, guided in part by menopausal status. Sex therapy includes behavior therapy, cognitive behavior therapy, and mindfulness. The only central nervous system agent currently approved by the US Food and Drug Administration (FDA) for HSDD is flibanserin in premenopausal women; use of flibanserin in postmenopausal women with HSDD is supported by data but is not FDA approved. Hormonal therapy includes off-label use of testosterone in postmenopausal women with HSDD, which is supported by data but not FDA approved. The POC incorporates monitoring the progress of therapy. In conclusion, the International Society for the Study of Women's Sexual Health POC for the management of women with HSDD provides a rational, evidence-based guideline for health care professionals to manage patients with appropriate assessments and individualized treatments., (Copyright © 2017 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

Sexual dysfunction in women is common and often goes unreported and untreated. Its management is part of patient-centered primary care. Primary care providers are uniquely positioned to identify and assess sexual health concerns of their patients, provide reassurance regarding normal sexual function, and treat sexual dysfunction or refer as appropriate., (Copyright © 2017 Cleveland Clinic.)

This review describes the evolving role of oral hormone therapy (HT) for treating menopausal symptoms and preventing osteoporosis, focusing on conjugated estrogens/bazedoxifene (CE/BZA). Estrogens alleviate hot flushes and prevent bone loss associated with menopause. In nonhysterectomized women, a progestin should be added to estrogens to reduce the risk of endometrial cancer. Use of HT declined since the Women's Health Initiative (WHI) studies showed that HT does not prevent coronary heart disease (CHD) and that conjugated estrogens/medroxyprogesterone acetate increased the risk of invasive breast cancer after nearly 5 years of use. However, re-analyses of the WHI data suggest that some risks (eg, CHD, all-cause mortality) may be reduced when HT is initiated in women <60 years of age and <10 years since menopause, compared with later. CE/BZA is the first menopausal HT without a progestogen for nonhysterectomized women. Instead, BZA, a selective estrogen receptor modulator, in combination with CE, protects against estrogenic effects on uterine and breast tissue. Data from 5 large, randomized clinical trials show that CE/BZA reduces hot flush frequency/severity, prevents bone loss, reduces bone turnover, improves the vaginal maturation index and ease of lubrication, and improves some measures of sleep and menopause-specific quality of life. In studies of up to 2 years, there was no increase in endometrial hyperplasia, vaginal bleeding, breast density, or breast pain/tenderness compared with placebo. Venous thromboembolism and stroke are risks of all estrogen-based therapies. The choice of HT should be individualized, with consideration of the risk/benefit profile and tolerability of therapy, as well as patient preferences.

The objective of the International Society for the Study of Women's Sexual Health expert consensus panel was to develop a concise, clinically relevant, evidence-based review of the epidemiology, physiology, pathogenesis, diagnosis, and treatment of hypoactive sexual desire disorder (HSDD), a sexual dysfunction affecting approximately 10% of adult women. Etiologic factors include conditions or drugs that decrease brain dopamine, melanocortin, oxytocin, and norepinephrine levels and augment brain serotonin, endocannabinoid, prolactin, and opioid levels. Symptoms include lack or loss of motivation to participate in sexual activity due to absent or decreased spontaneous desire, sexual desire in response to erotic cues or stimulation, or ability to maintain desire or interest through sexual activity for at least 6 months, with accompanying distress. Treatment follows a biopsychosocial model and is guided by history and assessment of symptoms. Sex therapy has been the standard treatment, although there is a paucity of studies assessing efficacy, except for mindfulness-based cognitive behavior therapy. Bupropion and buspirone may be considered off-label treatments for HSDD, despite limited safety and efficacy data. Menopausal women with HSDD may benefit from off-label testosterone treatment, as evidenced by multiple clinical trials reporting some efficacy and short-term safety. Currently, flibanserin is the only Food and Drug Administration-approved medication to treat premenopausal women with generalized acquired HSDD. Based on existing data, we hypothesize that all these therapies alter central inhibitory and excitatory pathways. In conclusion, HSDD significantly affects quality of life in women and can effectively be managed by health care providers with appropriate assessments and individualized treatments., (Copyright © 2016 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

Introduction: Current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) definitions of sexual dysfunction do not identify all sexual problems experienced clinically by women and are not necessarily applicable for biologic or biopsychosocial management of female sexual dysfunction. A unified nomenclature system enables clinicians, researchers, and regulatory agencies to use the same language and criteria for determining clinical end points, assessing research results, and managing patients., Aim: To develop nomenclature with classification systems for female sexual desire, arousal, and orgasm disorders with definitions pertinent to clinicians and researchers from multiple specialties who contribute to the field of sexual medicine., Methods: Key national and international opinion leaders diverse in gender, geography, and areas of expertise met for 2 days to discuss and agree to definitions of female sexual desire, arousal, and orgasm disorders and persistent genital arousal disorder. The attendees consisted of 10 psychiatrists and psychologists; 12 health care providers in specialties such as gynecology, internal medicine, and sexual medicine; three basic scientists; and one sexuality educator, representing an array of societies working within the various areas of sexual function and dysfunction., Main Outcome Measure: A unified set of definitions was developed and accepted for use by the International Society for the Study of Women's Sexual Health (ISSWSH) and members of other stakeholder societies participating in the consensus meeting., Results: Current DSM-5 definitions, in particular elimination of desire and arousal disorders as separate diagnoses and lack of definitions of other specific disorders, were adapted to create ISSWSH consensus nomenclature for distressing sexual dysfunctions. The ISSWSH definitions include hypoactive sexual desire disorder, female genital arousal disorder, persistent genital arousal disorder, female orgasmic disorder, pleasure dissociative orgasm disorder, and female orgasmic illness syndrome., Conclusion: Definitions for female sexual dysfunctions that reflect current science provide useful nomenclature for current and future management of women with sexual disorders and development of new therapies., (Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Introduction: A nomenclature is defined as a classification system for assigning names or terms in a scientific discipline. A nosology more specifically provides a scientific classification system for diseases or disorders. Historically, the nosologic system informing female sexual dysfunction (FSD) has been the system developed by the American Psychiatric Association in its Diagnostic and Statistical Manual of Mental Disorders (DSM-III through DSM-5). Experts have recognized limitations of its use in clinical practice, including concerns that the DSM-5 system does not adequately reflect the spectrum and presentation of FSD., Aim: To review the central considerations and issues that underlie the development of a new evidence-based nomenclature that reliably and validly defines the categories of FSD and will effectively function in clinical and research settings, serve as a basis for International Classification of Diseases (ICD) codes, and provide regulatory guidance for interventions designed as FSD treatments., Methods: The International Society for the Study of Women's Sexual Health conducted a 2-day conference on nomenclature for FSD in December 2013. Key opinion leaders representing diverse areas of expertise discussed ideal characteristics, existing DSM definitions, and current and future ICD coding to develop consensus for this new nomenclature., Main Outcome Measure: A comprehensive appreciation of the parameters and characteristics essential to a new FSD nomenclature and terminology that will serve as the principal nosology for the description and diagnosis of FSD., Results: A critical appraisal of the essential elements of a classification system for diagnosing FSD was accomplished. The applicability of DSM-5 FSD definitions was challenged; and the considerations for developing a new nomenclature were discussed, including comorbidities, clinical thresholds, alternative etiologies, and validity., Conclusion: The essential elements for developing a valid, reliable, credible, and clinically applicable nosology for FSD were enumerated as a preamble to constructing the actual nosologic system (Part II)., (Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

In the World Health Organization's forthcoming eleventh revision of the International Classification of Diseases and Related Health Problems (ICD-11), substantial changes have been proposed to the ICD-10 classification of mental and behavioural disorders related to sexuality and gender identity. These concern the following ICD-10 disorder groupings: F52 Sexual dysfunctions, not caused by organic disorder or disease; F64 Gender identity disorders; F65 Disorders of sexual preference; and F66 Psychological and behavioural disorders associated with sexual development and orientation. Changes have been proposed based on advances in research and clinical practice, and major shifts in social attitudes and in relevant policies, laws, and human rights standards. This paper describes the main recommended changes, the rationale and evidence considered, and important differences from the DSM-5. An integrated classification of sexual dysfunctions has been proposed for a new chapter on Conditions Related to Sexual Health, overcoming the mind/body separation that is inherent in ICD-10. Gender identity disorders in ICD-10 have been reconceptualized as Gender incongruence, and also proposed to be moved to the new chapter on sexual health. The proposed classification of Paraphilic disorders distinguishes between conditions that are relevant to public health and clinical psychopathology and those that merely reflect private behaviour. ICD-10 categories related to sexual orientation have been recommended for deletion from the ICD-11., (© 2016 World Psychiatric Association.)

Background: Internal medicine residents care for a sizable number of patients with chronic pain. Programs need educational strategies to promote safe opioid prescribing., Objective: To describe a safe opioid prescribing education program utilizing an objective structured clinical examination (OSCE) and report the resulting impact on residents' knowledge, confidence, and self-reported practices., Methods: Using a quasi-experimental design, 39 internal medicine residents from an urban academic medical center were assigned to 1 of 4 groups: 1-hour lecture only, lecture followed by immediate OSCE, lecture followed by 4-month delayed OSCE, and control. Safe opioid prescribing knowledge, confidence, and self-reported practices were assessed at baseline and at 8 months., Results: At 8 months, knowledge, confidence, and self-reported practices improved in the control and in all 3 intervention groups. The immediate OSCE group had the greatest improvements in combined confidence scores within group (0.74, P = .01) compared to controls (0.52, P = .05), using a 5-point scale. This group also had the greatest improvement in self-reported practice changes (1.04, P = .04), while other groups showed nonsignificant improvements-delayed OSCE (0.43, P = .44), lecture only (0.66, P = .24), and control (0.43, P = .19)., Conclusions: Safe opioid prescribing education that includes a lecture immediately followed by an OSCE had an impact on residents' confidence and self-reported practices greater than those for delayed OSCE or lecture only groups. There was no difference in knowledge improvement among the groups. Lecture followed by an OSCE was highly regarded by residents, but required additional resources.

Introduction: Hypoactive Sexual Desire Disorder (HSDD) is defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Revised (DSM-IV-TR) as persistent deficient sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty. In the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), HSDD has been subsumed by Female Sexual Interest/Arousal Disorder. However, decades of research based on DSM-IV-TR HSDD criteria form the foundation of our understanding of the essential symptom of distressing low sexual desire, its epidemiology, clinical management, and treatment., Aim: This publication reviews the state of knowledge about HSDD., Methods: A literature search was performed using terms HSDD and female sexual dysfunction (FSD)., Main Outcome Measures: Physicians acknowledge that FSD is common and distressing; however, they infrequently address it, citing low confidence, time constraints, and lack of treatment as barriers., Results: HSDD is present in 8.9% of women ages 18 to 44, 12.3% ages 45 to 64, and 7.4% over 65. Although low sexual desire increases with age, distress decreases; so prevalence of HSDD remains relatively constant across age. HSDD is associated with lower health-related quality of life; lower general happiness and satisfaction with partners; and more frequent negative emotional states. HSDD is underdetected and undertreated. Less than half of patients with sexual problems seek help from or initiate discussions with physicians. Patients are inhibited by fear of embarrassing physicians and believe that physicians should initiate discussions. The Decreased Sexual Desire Screener, a tool for detecting and diagnosing HSDD, is validated for use in general practice., Conclusion: Women can benefit from intervention in primary care, behavioral health and sexual medicine settings. Psychotherapeutic and pharmacological interventions aim to enhance sexual excitatory process and decrease inhibitory processes. Flibanserin, the first centrally acting daily medication for HSDD, was recently approved in the US for premenopausal women., (Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)