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BACKGROUND: Sexual interest/arousal disorder (SIAD) is one of the most common sexual problems for women. In clinical research, there are often misalignments between the research priorities of patients and researchers, which can negatively impact care, and gender-diverse individuals are often excluded from research. Inclusion of patient perspectives when establishing research priorities may help to reduce these gaps; however, the research priorities of couples coping with SIAD remain unclear. AIM: Identify the research priorities of women and gender-diverse individuals with SIAD and their partners. METHODS: In an online survey, couples coping with SIAD provided consent and responded to an open-ended question asking them to list the top 3 things they think are important for researchers to focus on related to couples coping with low sexual desire. A team-based content analysis was conducted to identify themes and their frequency of endorsement. OUTCOMES: An author-developed open-ended question. RESULTS: Analysis of 1279 responses (n = 667 from women and gender-diverse individuals with SIAD, n = 612 from partners) resulted in our identification of 6 main themes: general causes, general treatment and coping, biophysiological, relationship, psychological, and environmental/contextual. Additionally, we identified 4 sub-themes within each of the latter 4 main themes: general, cause, treatment, and impact. For women and gender-diverse individuals with SIAD, their partners, and specifically gender-diverse participants, the 3 most endorsed themes were psychological general factors (24.3%, 21.2%, 24.3%; eg, stress and the link between SIAD and anxiety), relationship general factors (15.7%, 13.2%, 18.6%; eg, relationship length and communication on sexual desire), and biophysiological general factors (12.3%, 12.4%, 14.3%; eg, research on medications and hormones). CLINICAL IMPLICATIONS: Clinical researchers should consider the research priorities of couples coping with SIAD to ensure their work aligns with the needs of the affected population. STRENGTHS AND LIMITATIONS: This study is the first to identify the research priorities of both women and gender-diverse individuals with SIAD and their partners. Most participants identified as heterosexual, North American, and of middle to high socioeconomic status; results may not generalize. Responses were sometimes brief and/or vague; interpretation of these responses was therefore limited and may have required more contextual information. CONCLUSION: Findings suggest that women and gender-diverse individuals with SIAD, their partners, and gender-diverse participants have similar research priorities that are consistent with a biopsychosocial approach to research. Heterogeneity of responses across themes supports a multidisciplinary, patient-oriented approach to SIAD research.

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Low desire in women is the most common sexual difficulty, and stress has been identified as a significant predictor of symptoms. We evaluated a mindfulness-based cognitive therapy (MBCT) group treatment versus a sex education comparison group treatment (STEP) on self-reported stress and on the physiological stress response measured via morning-to-evening cortisol slope in 148 women with a diagnosis of sexual interest/arousal disorder (SIAD). Perceived stress decreased following treatment in both groups, and significantly more after MBCT. The cortisol slope was steeper (indicative of better stress system regulation) from pre-treatment to 6-month follow-up, with no differences between the groups. As an exploratory analysis, we found that the reduction in perceived stress predicted increases in sexual desire and decreases in sex-related distress for participants after MBCT only. These findings suggest that group mindfulness targeting women with low sexual desire leads to improvements in self-reported and physiological stress, with improvements in self-reported stress partially accounting for improvements in sexual desire and distress.

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Sexual Interest/Arousal Disorder (distressing, long-lasting impairments in sexual desire and/or arousal) is common in women, but few have access to efficacious psychotherapies, including cognitive-behavioral therapy (CBT) and mindfulness-based therapy (MBT). eSense, an online program meant to maximize treatment access, has been shown to be a feasible, satisfactory, and potentially efficacious intervention. However, subpopulations such as sexual assault survivors may find the program less usable or efficacious. The current study compared women with and without a history of sexual assault (SA) regarding their ability to use and benefit from eSense. Forty-four women (22 with a history of SA; M age = 34.20 years) used eSense (CBT or MBT) and completed validated self-report scales of sexual function, sexual distress, treatment satisfaction, and homework compliance. A history of SA did not predict differences in attrition or changes in clinical outcomes. Exploratory analyses suggested that women with a history of SA reported slightly higher difficulty completing homework assignments, but also slightly higher treatment satisfaction. These preliminary results suggest that eSense may be usable and helpful for women with a history of SA. We discuss ways to maximize the acceptability and efficacy of online programs for women with a history of SA.

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Many possible factors impact sexual wellbeing for women across the lifespan, and holistic approaches are being utilized to promote health and to address sexual concerns. Female sexual dysfunction disorders, including female orgasmic disorder, female sexual interest/arousal disorder and genito-pelvic pain/penetration disorder, negatively impact quality of life for many women. To reduce distress and improve sexual functioning, numerous behavioral therapies have been tested to date. Here, we present a state-of-the-art review of behavioral therapies for female sexual dysfunction disorders, focusing on empirically validated approaches. Multiple psychotherapies have varying degrees of support, with cognitive-behavioral and mindfulness-based therapies arguably having the most empirical support. Nonetheless, several limitations exist of the studies conducted to date, including the frequent grouping together of multiple types of sexual dysfunctions in randomized clinical trials. Thus, additional research is needed to advance treatment development for female sexual dysfunctions and to promote female sexual health.

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Objectives: Difficulties with sexual desire impact up to a third of women and most do not seek or receive appropriate care for these complaints, in part due to stigma, embarrassment, and limited availability of treatment. In-person mindfulness-based interventions have lasting benefits to sexual desire and sex-related distress in controlled clinical trials but are difficult to access. Online cognitive-behavioral interventions for sexual concerns have shown promising findings, but online mindfulness interventions have received little testing. The current study assessed the feasibility of an online program (called eSense-Mindfulness) adapted from an effective face-to-face intervention for women with Sexual Interest/Arousal Disorder. Methods: Thirty cisgender women (M age = 35.3) with Sexual Interest/Arousal Disorder consented and completed at least one of the eight modules of eSense-Mindfulness while providing weekly feedback regarding their experience. Feasibility was assessed via attrition rates and participant self-report regarding challenges of using the program. Limited efficacy testing was based on effect sizes for changes in sexual response and sex-related distress. Results: Participants (n = 25 who completed all testing) reported high levels of usability and ease of understanding content and reported the mindfulness exercises as well as the information on partner communication to be the most relevant. Limited efficacy testing showed large effect sizes for reductions in sex-related distress, and improvements in sexual desire, arousal, and satisfaction whereas there were smaller effect sizes for improvements in lubrication, orgasm, and vaginal pain. Conclusions: The findings suggest that efficacious face-to-face mindfulness interventions for sexual dysfunction in women show excellent evidence of feasibility when delivered online without personalized guidance.

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INTRODUCTION: Hypoactive Sexual Desire Disorder (HSDD) / Female Sexual Interest/Arousal Disorder (FSIAD) impacts health-related quality of life (HRQoL) of women and their partners, yet existing measures fail to adequately capture relevant concepts (ie, what is essential to measure including symptoms/impacts) important to women with HSDD/FSIAD. OBJECTIVES: To identify HRQoL tools used to assess women with HSDD/FSIAD, and to evaluate their psychometric properties (ie, reliability, validity, and responsiveness). METHODS: We conducted searches in PubMed, Embase and PsychINFO from June 5, 1989 to September 30, 2020 for studies in women with HSDD/FSIAD and psychometric analyses (English only). Principles of the Preferred Reporting Items for Systematic reviews and Meta-Analyses, the COnsensus-based Standards for the selection of health Measurement INstruments Risk of Bias Checklist and other psychometric criteria were applied. Based on this search, 56 papers were evaluated including 15 randomized-controlled trials, 11 observational/single arm/open label studies, and 30 psychometric studies. RESULTS: Of the 18 measures identified, the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R) were included in most studies (> 50%). General HRQoL instruments were not used in any of the clinical trials; the SF-12, SF-36 and EQ-5D-5L were reported in two observational studies. No instruments achieved positive quality ratings across all psychometric criteria. The FSFI, FSDS-R, Sexual Event Diary (SED) and the Sexual Desire Relationship Distress Scale (SDRDS), were the only measures to receive a positive rating for content validity. CONCLUSION: Reliable and valid HRQoL measures that include sexual desire and distress are needed to provide a more systematic and comprehensive assessment of HRQoL and treatment benefits in women with HSDD/FSIAD. While inferences about HRQoL are limited due to the lack of uniformity in concepts assessed and limited psychometric evaluation of these measures in women with HSDD/FSIAD, opportunities exist for the development of reliable and validated tools that comprehensively measure the most relevant and important concepts in women with HSDD/FSIAD. Lim-Watson MZ, Hays RD, Kingsberg S, et al. A systematic literature review of health-related quality of life measures for women with Hypoactive Sexual Desire Disorder and Female Sexual Interest/Arousal Disorder. Sex Med Rev 2022;10:23-41.

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OBJECTIVES: Difficulties with sexual desire and arousal are common in women, but most lack access to effective treatment such as cognitive-behavioral therapy (CBT). eSense is a recently created online CBT intervention for sexual difficulties with promising evidence of usability. The current study assessed the feasibility of women completing the full eSense CBT program without guidance. METHODS: Eleven women with Sexual Interest/Arousal Disorder completed eSense and provided feedback via semi-structured interviews. RESULTS: Participants reported high satisfaction with eSense's functionality, improved knowledge about sexuality, greater awareness of their thought patterns, and better perspective around their sexual difficulties. Despite some difficulty completing homework, participants exhibited statistically significant pre-post improvements in sexual desire (d = 1.04), sexual arousal (d = 1.83), sexual satisfaction (d = 1.35), and sexual distress (d = 1.79). CONCLUSION: The findings add to the growing evidence that self-guided online interventions are feasible and potentially efficacious in treating female sexual dysfunction.

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BACKGROUND: The experience of distressing low sexual interest/arousal-female sexual interest/arousal disorder (FSIAD)-is prevalent in women of all ages and is associated with poorer sexual, relationship, and psychological well-being than women without this difficulty. Women who are partnered are almost 5 times more likely to be distressed by low desire and to receive a diagnosis of FSIAD than unpartnered women, indicating that interpersonal factors are highly relevant, although largely neglected in past research. AIM: In a dyadic cross-sectional and longitudinal study, we examined whether partner responses to FSIAD were associated with the sexual, relationship, and psychological well-being of couples, and whether any effects persisted 1 year later. METHODS: Women diagnosed with FSIAD (N = 89) completed a validated measure of perceived partner positive vs negative responses to their low sexual interest/arousal and their partners reported on their own responses, as well as measures of sexual desire, sexual satisfaction, relationship satisfaction, sexual distress, and anxiety. 1 year later, couples (N = 66) completed the outcome measures again. Data were analyzed according to the Actor-Partner Interdependence Model. OUTCOMES: Outcomes included were the Sexual Desire Inventory-Solitary and Partner-Focused Subscales; Global Measure of Sexual Satisfaction; Female Sexual Distress Scale; Couple Satisfaction Index; and State-Trait Anxiety Inventory-Short-Form. RESULTS: When women with FSIAD perceived more positive partner responses (eg, warm, supportive, compassionate) than negative responses (eg, hostile, unsupportive, indifferent), they were more satisfied with the relationship and they and their partners reported lower anxiety. When partners reported more positive than negative responses, they had greater relationship and sexual satisfaction and lower sexual distress and anxiety. Exploratory analyses revealed that women's perceptions of their partners' responses accounted for the link between partners' own responses and women's relationship satisfaction and anxiety. Partner responses did not predict any change in outcomes over time. CLINICAL IMPLICATIONS: Findings support interpersonal conceptualizations of FSIAD and may inform the development of future couple-based interventions. STRENGTHS & LIMITATIONS: This study is one of the few dyadic investigations of FSIAD, as diagnosed via a clinical interview. Significant associations were only observed cross-sectionally, limiting causal conclusions. There was limited power to detect longitudinal effects. CONCLUSION: More positive responses to women's low sexual interest/arousal by partners is linked to better adjustment among couples affected by FSIAD. Rosen NO, Corsini-Munt S, Dubé JP, et al. Partner Responses to Low Desire: Associations With Sexual, Relational, and Psychological Well-Being Among Couples Coping With Female Sexual Interest/Arousal Disorder. J Sex Med 2020;17:2168-2180.

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BACKGROUND: Low sexual desire and arousal are the most common sexual concerns in women, but most women lack access to effective treatment such as cognitive behavioral therapy. Web-based psychological interventions, which are economical, private, easily accessible, and potentially effective, may increase the reach of evidence-based treatment. AIM: To determine the feasibility of translating cognitive behavioral therapy for the most common female sexual dysfunction, Female Sexual Interest/Arousal Disorder, into an online format. The present study examined the feasibility of an introductory psychoeducational module of eSense, an online program currently being developed that is based on existing empirically supported in-person treatments, which delivers content to the user in a visually appealing and interactive manner. METHODS: Sixteen cisgender women (M age = 31.9) with female sexual arousal/interest disorder worked through a pilot module of eSense inperson at a sexual health laboratory. OUTCOMES: Qualitative semistructured interviews and online questionnaires were used to assess participants' experiences of usability of the platform, clarity/relevance of the content, satisfaction with the experience, and any changes in clinical outcomes of sexual function and distress. RESULTS: Participants reported a high level of satisfaction with the website's functionality and presentation. They reported greater knowledge, felt validated and more hopeful, and were eager to continue the remaining modules. Participants also reported notable prepost improvements in sexual desire, arousal, and satisfaction. CLINICAL IMPLICATIONS: Initial user-experience assessment may represent a method of simultaneously improving online interventions and providing therapeutic education to participants. STRENGTHS & LIMITATIONS: This is one of the first studies, to our knowledge, to test a graphics-rich, interactive online intervention for sexual difficulties that does not require direct contact with expert providers or support groups. Limitations include the high level of education, motivation, and technical fluency of the sample and the potentially confounding effect of the researcher's presence during interviews. Because this was a feasibility study, the sample size was small, and no control group was included, limiting conclusions about efficacy and generalizability. CONCLUSION: The format of eSense appears to be feasible and usable, lending support to the growing evidence that it is possible to take in-person therapeutic interventions online. Zippan N, Stephenson KR, Brotto LA, Feasibility of a Brief Online Psychoeducational Intervention for Women With Sexual Interest/Arousal Disorder. J Sex Med 2020;17:2208-2219.

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Objective: Hypoactive sexual desire disorder (HSDD) in women has been viewed inaccurately by some in the medical and payer community as analogous to erectile dysfunction (ED) in men. This literature review aims to highlight the distinctions between HSDD and ED.Methods: Two systematic literature searches were conducted on the epidemiology, symptomatology and biopsychosocial outcomes of HSDD and ED. Studies published since 2007 were considered for HSDD; studies published since 2012 were considered for ED.Results: HSDD in women is primarily a central nervous system condition related to neuroendocrine factors, whereby neural pathways that regulate sexual excitation and/or inhibition appear to be involved. A combination of organic and psychogenic factors often contributes to ED. HSDD and ED are associated with similar psychological and interpersonal consequences, but affect different phases of the sexual response model (desire versus arousal) and have different pathophysiologies, therefore requiring different treatment and outcome paradigms. ED is measured by objective, physiological responses (erection and sexual function), but quantitative assessments for HSDD are more difficult because loss of desire with associated distress has to be assessed. Outcome measures used to assess ED, such as the number of satisfying sexual events, are far less informative as an endpoint for randomized clinical trials of treatments for HSDD.Conclusions: HSDD and ED are distinct conditions affecting different phases of the sexual response model, and thus require clear and unique clinical characterization and adequate communication between the health care professional and patient for appropriate diagnosis, management and treatment.

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INTRODUCTION: Female sexual interest/arousal disorder (FSIAD) affects many women worldwide, but pharmacological treatment options are scarce. A new medicine being developed for FSIAD is an on-demand, dual-route, dual-release drug combination product containing 0.5 mg testosterone (T) and 50 mg sildenafil (S), referred to here as T+S. AIM: The aim of this study was to compare the effect of a fed and a fasted state on the pharmacokinetics of sildenafil following administration of T+S. METHODS: Eighteen healthy women were administered T+S under fed and fasted conditions during 2 separate overnight visits in this randomized, open-label, balanced, 2-period, 2-treatment, 2-sequence crossover study. MAIN OUTCOME MEASURES: The pharmacokinetics of sildenafil and its active metabolite N-desmethyl sildenafil were determined over a 24-hour period. Total testosterone was assessed only at a limited number of time points for quality purposes, as sublingual uptake is not expected to be affected by food intake. RESULTS: The observed geometric mean ratios (GMRs) and 90% confidence intervals of sildenafil were not all contained within the prespecified bounds (0.80, 1.25). The GMR (90% CI) for plasma AUC0-last was 1.2753 (0.9706-1.6755); for AUC0-14h, it was 1.7521 (1.0819-2.8374); and for Cmax, it was 1.5591 (0.8634-2.8153). Only lower limits of the CIs fell within the bounds. For N-desmethyl sildenafil, the GMR (90% CI) for AUC0-last was 0.8437 (0.6738-1.0564); for AUC0-10h, it was 1.0847 (0.7648-1.5383); and for Cmax, it was 1.0083 (0.6638-1.5318). Only the GMRs were contained within bounds. No differences were observed between plasma testosterone Cmax and Tmax under fed and fasted conditions, which is in line with expectations for a sublingual administration. CLINICAL IMPLICATIONS: The T+S combination tablet ruptures too late when taken in a fasted state and should therefore not be taken on an empty stomach. STRENGTHS & LIMITATIONS: This is a well-controlled study that provides important insights into the performance characteristics of the delayed-release coating of the combination tablet. The higher variability of the pharmacokinetic parameters in the fasted state was caused by severely delayed rupture in one-third of the women. A reason for this is proposed but the present data do not explain this phenomenon. CONCLUSION: The pharmacokinetics of sildenafil from this modified-release tablet are more robust under fed conditions as compared to the artificial fasted condition where no food is consumed 10 hours prior to and 4 hours after dosing. The dosing situation under the tested fasting condition does not represent the expected common use of this product. Patients should, however, be instructed not to take the tablet on an empty stomach. Bloemers J, Gerritsen J, van Rooij K, et al. The Effect of Food on the Pharmacokinetics of Sildenafil After Single Administration of a Sublingual Testosterone and Oral Sildenafil Combination Tablet in Healthy Female Subjects. J Sex Med 2019; 19:1433-1443.

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Female sexual interest/arousal disorder (FSIAD) is associated with psychological, relational, and sexual consequences for affected women, and their romantic partners also suffer repercussions. Prior research suggests that women with FSIAD report more difficulties with emotion regulation than controls. Yet, whether emotion regulation is associated with the psychological, relational, and sexual well-being of both members of affected couples is unknown. Eighty-seven women diagnosed with FSIAD via a clinical interview and their male partners completed standardized measures of difficulties in emotion regulation, depression, anxiety, relationship satisfaction, dyadic conflict, sexual desire, and sexual distress. A subset (n = 71 couples) also completed measures of emotional suppression and reappraisal in relation to sex. Analyses used multilevel modeling guided by the actor-partner interdependence model. When women reported greater difficulties regulating negative emotion, they reported greater depression and anxiety, and when men reported more of these difficulties, they had greater depression, anxiety, and sexual distress, and the women with FSIAD reported lower relationship satisfaction. When women reported greater emotional suppression, they reported greater depression and anxiety, and lower relationship satisfaction; when they reported greater use of emotional reappraisal, they had fewer symptoms of depression and anxiety, and their partners reported lower dyadic conflict. When men reported greater emotional suppression, they had greater depression, lower relationship satisfaction, and sexual desire; when they reported greater emotional reappraisal, they had lower depression and anxiety, higher relationship satisfaction, lower dyadic conflict, higher sexual desire and women reported higher relationship satisfaction and lower dyadic conflict. Emotion regulation may be an important target for interventions to help couples cope with FSIAD.

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INTRODUCTION: Women diagnosed with female sexual interest/arousal disorder (FSIAD) report lower health-related quality of life, more depressive symptoms, and lower sexual and relationship satisfaction compared with healthy control subjects. Despite the impact of FSIAD on women's sexuality and the inherently interpersonal nature of the sexual problem, it remains unclear whether the partners of women with FSIAD also face negative consequences, as seen in other sexual dysfunctions. AIM: The aim of this study was to compare the sexual, relational, and psychological functioning of partners of women with FSIAD (as well as the women themselves) to their control counterparts. We also compared women with their partners within the FSIAD and control groups. METHODS: Woman diagnosed with FSIAD and their partners (n = 97) and control couples (n = 108) independently completed measures of sexual desire, sexual distress, sexual function, sexual satisfaction, sexual communication, relationship satisfaction, depression, and anxiety. MAIN OUTCOME MEASURE: Main outcomes included: Sexual Desire Inventory-2; Female Sexual Distress Scale; Female Sexual Functioning Index; International Index of Erectile Functioning (IIEF), Global Measure of Sexual Satisfaction; Dyadic Sexual Communication Scale; Couple Satisfaction Index; Beck Depression Inventory-II; State-Trait Anxiety Inventory-Short Form. RESULTS: Partners of women with FSIAD reported lower sexual satisfaction, poorer sexual communication, and higher sexual distress compared with control partners. Male partners of women with FSIAD reported more difficulties with orgasmic and erectile functioning and lower overall satisfaction and intercourse satisfaction on the IIEF compared with control partners. Women with FSIAD reported lower sexual desire and satisfaction, and higher sexual distress and depressive and anxiety symptoms, in comparison to both control women and their own partners, and they reported poorer sexual communication compared with control women. Women with FSIAD also reported lower sexual desire, arousal, lubrication, and satisfaction, and greater pain during intercourse on the Female Sexual Function Index compared with control women. CLINICAL IMPLICATIONS: The partners of women with FSIAD also experience negative consequences-primarily in the domain of sexuality. Partners should be included in treatment and future research. STRENGTH & LIMITATIONS: This is the first study, to our knowledge, to document consequences for partners of women with FSIAD in comparison to control subjects. This study is cross-sectional, and causation cannot be inferred. Most couples were in mixed-sex relationships and identified as straight and cis-gendered; results may not generalize. CONCLUSION: Findings suggest that partners of women with FSIAD experience disruptions to many aspects of their sexual functioning, as well as lower overall sexual satisfaction and heightened sexual distress. Rosen NO, Dubé JP, Corsini-Munt S, et al. Partners Experience Consequences, Too: A Comparison of the Sexual, Relational, and Psychological Adjustment of Women with Sexual Interest/Arousal Disorder and Their Partners to Control Couples. J Sex Med 2019;16:83-95.

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Attempts to develop a drug treatment for female sexual interest/arousal disorder have so far been guided by the principle of 'one size fits all', and have failed to acknowledge the complexity of female sexuality. Guided by personalized medicine, we designed two on-demand drugs targeting two distinct hypothesized causal mechanisms for this sexual disorder. The objective of this study was to design and test a novel procedure, based on genotyping, that predicts which of the two on-demand drugs will yield a positive treatment response. In a double-blind, randomized, placebo-controlled cross-over experiment, 139 women with female sexual interest/arousal disorder received three different on-demand drug-combination treatments during three 2-week periods: testosterone 0.5 mg + sildenafil 50 mg, testosterone 0.5 mg + buspirone 10 mg, and matching placebo. The primary endpoint was change in satisfactory sexual events. Subjects' genetic profile was assessed using a microarray chip that measures 300,000 single-nucleotide polymorphisms. A preselection of single-nucleotide polymorphisms associated with genes that are shown to be involved in sexual behaviour were combined into a Phenotype Prediction Score. The Phenotype Prediction Score demarcation formula was developed and subsequently validated on separate data sets. Prediction of drug-responders with the Phenotype Prediction Score demarcation formula gave large effect sizes (d = 0.66 through 1.06) in the true drug-responders, and medium effect sizes (d = 0.51 and d = 0.47) in all patients (including identified double, and non-responders). Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the Phenotype Prediction Score demarcation formula were all between 0.78 and 0.79, and thus sufficient. The resulting Phenotype Prediction Score was validated and shown to effectively and reliably predict which women would benefit from which on-demand drug, and could therefore also be useful in clinical practice, as a companion diagnostic establishing the way to a true personalized medicine approach.

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BACKGROUND: Efficacy of on-demand drugs for women with hypoactive sexual desire disorder or female sexual interest/arousal disorder (FSIAD) should be assessed using a validated instrument that assesses the discrete sexual events during which the on-demand drug is taken, because this type of assessment is more proximate to an on-demand drug's efficacy compared to instruments that assess sexual function over longer periods of time. AIM: The aim of this study was to assess the psychometric properties of the Dutch translation of the previously validated 11-item Sexual Event Diary (SED) for measuring sexual satisfaction and sexual functioning during discrete sexual events. METHODS: Psychometric assessment was performed on data of 1,840 SEDs from 139 women with hypoactive sexual desire disorder/FSIAD, collected during a randomized clinical cross-over trial conducted in the Netherlands. OUTCOMES: Item scores of the SED at the event level, and at subject level, summarized item scores during the placebo run-in period (PRI) and active treatment period, and score changes from PRI to active treatment period. RESULTS: Reliability and convergent validity were confirmed. All item scores showed the ability to discriminate between known groups. Larger mean score changes from PRI were observed in groups with known benefit from the medication, as compared to those with no benefit. Guyatt effect sizes ranged from 0.51-1.02, thereby demonstrating ability to detect change. CLINICAL TRANSLATION: The Dutch version of the SED is an excellent instrument for assessing female sexual functioning and sexual satisfaction during discrete sexual events and for assessing these concepts over longer periods of time. CONCLUSIONS: Data were collected in a randomized, well-controlled trial. The large number of data points gave high statistical power, and the results confirmed previous findings. However, care is needed when generalizing the SED's validity to other areas of research, eg, recreational drug use and sexual risky behaviors, since the current validation study has not used such data. Consistent with the US-English version, the Dutch version of the SED is a reliable, valid, and responsive instrument, and suitable for use in evaluating effects of on-demand drugs in women with FSIAD. van Nes Y, Bloemers J, Kessels R, et al. Psychometric Properties of the Sexual Event Diary in a Sample of Dutch Women With Female Sexual Interest/Arousal Disorder. J Sex Med 2018;15:722-731.

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BACKGROUND: In women, low sexual desire and/or sexual arousal can lead to sexual dissatisfaction and emotional distress, collectively defined as female sexual interest/arousal disorder (FSIAD). Few pharmaceutical treatment options are currently available. AIM: To investigate the efficacy and safety of 2 novel on-demand pharmacologic treatments that have been designed to treat 2 FSIAD subgroups (women with low sensitivity for sexual cues and women with dysfunctional over-activation of sexual inhibition) using a personalized medicine approach using an allocation formula based on genetic, hormonal, and psychological variables developed to predict drug efficacy in the subgroups. METHODS: 497 women (21-70 years old) with FSIAD were randomized to 1 of 12 8-week treatment regimens in 3 double-blinded, randomized, placebo-controlled, dose-finding studies conducted at 16 research sites in the United States. Efficacy and safety of the following on-demand treatments was tested: placebo, testosterone (T; 0.5 mg), sildenafil (S; 50 mg), buspirone (B; 10 mg) and combination therapies (T 0.25 mg + S 25 mg, T 0.25 mg + S 50 mg, T 0.5 mg + S 25 mg, T 0.5 mg + S 50 mg, and T 0.25 mg + B 5 mg, T 0.25 mg + B 10 mg, T 0.5 mg + B 5 mg, T 0.5 mg + B 10 mg). OUTCOMES: The primary efficacy measure was the change in satisfying sexual events (SSEs) from the 4-week baseline to the 4-week average of the 8-week active treatment period after medication intake. For the primary end points, the combination treatments were compared with placebo and the respective monotherapies on this measure. RESULTS: In women with low sensitivity for sexual cues, 0.5 mg T + 50 mg S increased the number of SSEs from baseline compared with placebo (difference in change [Δ] = 1.70, 95% CI = 0.57-2.84, P = .004) and monotherapies (S: Δ = 1.95, 95% CI = 0.44-3.45, P = .012; T: Δ = 1.69, 95% CI = 0.58-2.80, P = .003). In women with overactive inhibition, 0.5 mg T + 10 mg B increased the number of SSEs from baseline compared with placebo (Δ = 0.99, 95% CI = 0.17-1.82, P = .019) and monotherapies (B: Δ = 1.52, 95% CI = 0.57-2.46, P = .002; T: Δ = 0.98, 95% CI = 0.17-1.78, P = .018). Secondary end points followed this pattern of results. The most common drug-related side effects were flushing (T + S treatment, 3%; T + B treatment, 2%), headache (placebo treatment, 2%; T + S treatment, 9%), dizziness (T + B treatment, 3%), and nausea (T + S treatment, 3%; T + B treatment, 2%). CLINICAL IMPLICATIONS: T + S and T + B are promising treatments for women with FSIAD. STRENGTHS AND LIMITATIONS: The data were collected in 3 well-designed randomized clinical trials that tested multiple doses in a substantial number of women. The influence of T + S and T + B on distress and the potentially sustained improvements after medication cessation were not investigated. CONCLUSIONS: T + S and T + B are well tolerated and safe and significantly increase the number of SSEs in different FSIAD subgroups. Tuiten A, van Rooij K, Bloemers J, et al. Efficacy and Safety of On-Demand Use of 2 Treatments Designed for Different Etiologies of Female Sexual Interest/Arousal Disorder: 3 Randomized Clinical Trials. J Sex Med 2018;15:201-216.

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BACKGROUND: The efficacy of on-demand drugs for hypoactive sexual desire disorder (HSDD) or female sexual interest/arousal disorder (FSIAD) should be assessed using a validated instrument that assesses the discrete sexual events during which the on-demand drug is taken. AIM: To develop and validate an event log for measuring sexual satisfaction and sexual functioning of discrete sexual events. METHODS: Psychometric assessment was carried out on data of 10,959 Sexual Event Diaries (SEDs) collected during three clinical trials in a total of 421 women with HSDD. Cognitive debriefing interviews were held with 16 women with HSDD. OUTCOMES: Item scores of the SED at the event level and at the subject level, summarized item scores of women during the baseline establishment and active treatment periods, and score changes in women from baseline establishment to active treatment. RESULTS: Several items of the initial 16-item SED items showed weak validity. The 16-item SED was refined to the 11-item SED. The reliability, content, and convergent validity of the 11-item SED were confirmed. For most 11-item SED item scores, the ability to discriminate between known groups was confirmed. Larger mean score changes from the baseline establishment period were found in those with than in those without known benefit from the medication, and Guyatt effect sizes ranged from 0.73 to 1.58, thereby demonstrating the ability to detect change. CLINICAL TRANSLATION: The SED is a good tool for assessing sexual function during a discrete sexual event and for assessing the sexual function of women over longer periods. STRENGTHS AND LIMITATIONS: The validation of the SED was performed on data from nearly 11,000 sexual events, gathered as part of a drug development program for HSDD and FSIAD. This amount of data provides very robust results when related to drug use for HSDD and FSIAD, but caution is advised when generalizing the validity of the SED directly to other areas of research (eg, recreational drug use and sexual risky behaviors), because such data were not used in this validation. CONCLUSIONS: The 11-item SED is a reliable, valid, and responsive instrument and suitable for use in evaluating the effects of on-demand drugs in women with HSDD or FSIAD. van Nes Y, Bloemers J, van der Heijden PGM, et al. The Sexual Event Diary (SED): Development and Validation of a Standardized Questionnaire for Assessing Female Sexual Functioning During Discrete Sexual Events. J Sex Med 2017;14:1438-1450.

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Low sexual desire is the most common sexual complaint in women, with multinational studies finding that at least a third of women experience low sexual desire. No single etiology for the development of Female Sexual Interest/Arousal Disorder, the diagnosis laid out by the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders, has been established. There has been considerable interest in pharmacological approaches to improving low desire, and agents targeting a range of neurotransmitters have been examined. To date, only flibanserin, a centrally acting medication targeting the serotonin, dopamine, and norepinephrine systems, has been approved by the Food and Drug Administration (FDA). Despite statistically significant effects on sexual desire, sexual distress, and sexually satisfying events, side-effects are significant, and flibanserin is completely contraindicated with alcohol. As such, there has been renewed interest in advancing the science of psychological approaches to low desire, including cognitive behavioral and mindfulness therapies.

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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.

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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).

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