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Objectives: To determine the prevalence of domestic violence among female patients and to identify clinical characteristics that are associated with current domestic violence.Design: Cross-sectional, self-administered, anonymous survey.Setting: 4 community-based, primary care internal medicine practices.Patients: 1952 female patients of varied age and marital, educational, and economic status who were seen from February to July 1993.Measurements: The survey instrument included previously validated questions on physical and sexual abuse, alcohol abuse, and emotional status and questions on demographic characteristics, physical symptoms, use of street drugs and prescribed medications, and medical and psychiatric history.Results: 108 of the 1952 respondents (5.5%) had experienced domestic violence in the year before presentation. Four hundred eighteen (21.4%) had experienced domestic violence sometime in their adult lives, 429 (22.0%) before age 18 years, and 639 (32.7%) as either an adult or child. Compared with women who had not recently experienced domestic violence, currently abused patients were more likely to be younger than 35 years of age (prevalence ratio [PR], 4.1 [95% CI, 2.8 to 6.0]); were more likely to be single, separated, or divorced (PR, 2.5 [CI, 1.7 to 3.6]); were more likely to be receiving medical assistance or to have no insurance (PR, 4.3 [CI, 2.8 to 6.6]); had more physical symptoms (mean, 7.3 +/- 0.38 compared with 4.6 +/- 0.08; P < 0.001); had higher scores on instruments for depression, anxiety, somatization, and interpersonal sensitivity (low self-esteem) (P < 0.001); were more likely to have a partner abusing drugs or alcohol (PR, 6.3 [CI, 4.4 to 9.2]); were more likely to be abusing drugs (PR, 4.4 [CI, 1.9 to 10.4]) or alcohol (PR, 3.1 [CI, 1.5 to 6.5]); and were more likely to have attempted suicide (PR, 4.3 [CI, 2.8 to 6.5]). They visited the emergency department more frequently (PR, 1.7 [CI, 1.2 to 2.5]) but did not have more hospitalizations for psychiatric disorders. In a logistic regression model into which 9 risk factors were entered, the likelihood of current abuse increased with the number of risk factors, from 1.2% when 0 to 1 risk factors were present to 70.4% when 6 to 7 risk factors were present.Conclusions: In a large, diverse, community-based population of primary care patients, 1 of every 20 women had experienced domestic violence in the previous year; 1 of every 5 had experienced violence in their adult life; and 1 of every 3 had experienced violence as either a child or an adult. Current domestic violence is associated with single or separated status, socioeconomic status, substance abuse, specific psychological symptoms, specific physical symptoms, and the total number of physical symptoms. [ABSTRACT FROM AUTHOR]

Objectives: To determine the prevalence of childhood physical or sexual abuse in women seen in primary care practices; to identify physical and psychologic problems associated with that abuse; and to compare the effects of childhood physical vs sexual abuse and childhood vs adult abuse.Design: Cross-sectional, self-administered, anonymous survey.Setting: Four community-based, primary care internal medicine practices.Patients: A total of 1931 women of varied age and marital, educational, and economic status examined from February through July 1993.Main Outcome Measures: Prevalence of physical and sexual abuse, physical symptoms, psychological symptoms (Symptom Checklist-22), alcohol abuse (CAGE questions), and street drug use.Results: Of the 1931 respondents, 424 (22.0%) reported childhood or adolescent physical or sexual abuse. Compared with women who reported never having experienced abuse (n=1257), women who reported abuse as children but not adults (n=204) had more physical symptoms (mean+/-SE, 6.2+/-0.2 vs 4.0+/-0.9; P<.001) and had higher scores for depression, anxiety, somatization, and interpersonal sensitivity (low self-esteem) (P<.001); were more likely to be abusing drugs (prevalence ratio [PR], 4.7; 95% confidence interval [CI], 2.9-7.6) or to have a history of alcohol abuse (PR, 2.2; 95% CI, 1.5-3.2); were more likely to have attempted suicide (PR, 3.7; 95% CI, 2.6-5.1); and were more likely to have had a psychiatric admission (PR, 3.2; 95% CI, 2.2-4.7). Women abused only as children did not differ from women who reported current, but not childhood, abuse in number of physical symptoms, emotional distress, substance abuse, or suicide attempts. Patients who reported both childhood and adult abuse had higher levels of psychological problems and physical symptoms than those who reported childhood or adult abuse alone.Conclusions: Childhood physical or sexual abuse is associated with adult health problems including physical symptoms, psychological problems, and substance abuse; for many variables, this association is as strong as for patients experiencing current abuse. [ABSTRACT FROM AUTHOR]

The Readiness Estimate and Deployability Index Revised for Air Force Nurses (READI-R-AFN) was derived from modifications of Reineck's Readiness Instrument. Reliability and validity of the READI-R-AFN was estimated on completed questionnaires of 181 active duty Air Force nurses. The READI-R-AFN was evaluated based on item analysis, internal consistency (alpha coefficient, >0.70), confirmatory factor analysis with structural equation modeling, and hypothesis testing. The findings were supported by Flannery's model of stress resistance. There was evidence of reliability and validity of the 83-item READI-R-AFN based on internal consistency (alpha, 0.80-0.96), structural equation modeling, and hypothesis testing. The original hypothesized six dimensions were retained. [ABSTRACT FROM AUTHOR]

Background: For the treatment of female sexual dysfunction, the most relevant outcome measures are patient-reported treatment effects and changes in symptoms, underscoring the need for reliable, validated patient-reported outcome (PRO) instruments. The aim of this study was to evaluate the psychometric characteristics (validity and reliability) of the Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) PRO measure, which was adapted from the validated FSDS-Revised (FSDS-R) questionnaire and added 2 questions involving arousal and orgasm., Methods: Psychometric analyses were based on the data from a multicenter phase 2b dose-finding study that compared the safety and efficacy of bremelanotide versus placebo and were conducted in the evaluable modified intent-to-treat population (N = 325) from that study. Psychometric evaluation of the new items in the FSDS-DAO included confirmatory factor analyses, tests of internal consistency and test-retest reliability, examinations of convergent and discriminant validity, and determination of responsiveness. The validity of the FSDS-DAO was evaluated based on previously developed instruments, including the Female Sexual Function Index (FSFI), General Assessment Questionnaire (GAQ), Women's Inventory of Treatment Satisfaction (WITS-9), and Female Sexual Encounter Profile-Revised (FSEP-R)., Results: Confirmatory factor analyses demonstrated that the FSDS-DAO items fit very well (Bentler's comparative fit index of 0.929). Cronbach's α for the FSDS-DAO total score was ≥ 0.91 at Visits 1, 2, 5, and 12, demonstrating adequate internal consistency reliability. Test-retest reliability was acceptable with an intra-class coefficient of 0.61 and a Spearman's correlation coefficient score of 0.62 between Visits 1 and 2 (4 weeks). Acceptable construct validity was demonstrated by significant correlations with related PRO scales in the expected directions and magnitude. For example, participants reporting the worst levels of sexual function on the FSFI also showed the worst FSDS-DAO scores at Visits 5 and 12. The FSDS-DAO total score was responsive to change., Conclusions: Evidence supports the validity and reliability of the FSDS-DAO for assessing sexually related distress in women with female sexual arousal disorder and/or hypoactive sexual desire disorder; the addition of the arousal and orgasm items did not impact the validity and reliability of the measure. Clinical Trial Registration ClinicalTrials.gov NCT01382719., (© 2021. The Author(s).)

Background: The Elements of Desire Questionnaire (EDQ) is a patient-reported outcome (PRO) measure developed to evaluate sexual desire and was included in two identically designed phase 3 clinical trials (RECONNECT) as an exploratory endpoint. The EDQ was developed based on a literature review, qualitative research with patients with hypoactive sexual desire disorder (HSDD), and input from clinical experts. This instrument is intended to be used to collect efficacy data in clinical trials evaluating potential treatments for HSDD. The objective of this study was to evaluate the measurement properties of both the monthly and daily recall versions of the EDQ during the RECONNECT trials., Methods: Participants completed the EDQ daily version for 7 consecutive days prior to selected monthly clinic visits. The monthly recall version was completed at each monthly clinic visit. The analysis population consisted of all subjects with Female Sexual Function Index (FSFI) data at baseline and ≥ 1 follow-up visit., Results: At baseline, 1144 and 676 subjects completed the monthly and daily recall EDQs, respectively. The EDQ scores had good internal consistency and test-retest reliability. Monthly and daily recall EDQ scores were correlated with FSFI-desire domain scores at baseline and month 3. Scores from the monthly and daily recall versions were also correlated. After 6 months, there was a significantly greater improvement for bremelanotide versus placebo in both the monthly and daily recall versions (both P < 0.0001)., Conclusions: The results demonstrated that EDQ exhibited good reliability, validity, and sensitivity to change. Consistent with other validated PRO measures of sexual desire, the EDQ provides additional insights into sexual desire., Trial Registration: NCT02338960 and NCT02333071 (RECONNECT studies).

Screening, diagnosis, and management of hypoactive sexual desire disorder (HSDD) and research into the condition have been challenging due to its biopsychosocial complexity and lack of consensus on relevant measures. Although physician interviews yield much clinically valid information, self-reported questionnaires appear more acceptable to patients and physicians. Consequently, validated patient-reported outcome (PRO) tools are essential for evaluation and management of HSDD, including any therapeutic intervention. The US Food and Drug Administration (FDA) has issued guidance on the use of appropriate endpoints and associated measures for female sexual dysfunction, including HSDD. Although many of the available measures were not designed specifically for HSDD assessment, as per FDA guidelines, most clinical studies have used individual domains or items from established tools, such as the Female Sexual Function Index-desire domain and Item 13 of the revised Female Sexual Distress Scale. For clinical practice, several professional societies recommend the Decreased Sexual Desire Screener and/or a sexual history as tools to diagnose HSDD. This review discusses frequently used PRO tools as well as the newly developed and validated Elements of Desire Questionnaire, which may be appropriate for clinical trials or clinical practice.

Objective: To quantify the association between vulvovaginal atrophy and depression, major depressive disorder, and anxiety., Methods: Women with vulvovaginal atrophy from the Truven Health MarketScan Commercial and Medicare Supplemental Databases (01/2010-09/2016) with ≥365 days of continuous insurance coverage before and after the first vulvovaginal atrophy/dyspareunia diagnosis (index date) were selected. Women with vulvovaginal atrophy were matched 1:3 to women without (controls) according to age, calendar year, health plan, and region. The study period spanned from 12 months before to 12 months after index date. The ratios of diagnosed depression, major depressive disorder, and anxiety among women with vulvovaginal atrophy and the controls were calculated. Logistic regressions adjusting for proxies of menopause were used to compare prevalence., Results: In all, 125,889 women with vulvovaginal atrophy and 376,057 controls were included (mean age 60.7 [45-101]). The prevalence of depression, major depressive disorder, and anxiety was higher among women with vulvovaginal atrophy compared with controls (23.9% vs 18.9%, 6.3% vs 4.7%, 16.6% vs 11.3%), with prevalence ratios of 1.26, 1.33, and 1.47, respectively (all P < 0.0001). Highest prevalences and differences were observed in younger women. Findings were consistent when analyzing newly diagnosed conditions. When adjusting for proxies of menopause (insomnia, vasomotor symptoms, dysuria, and estrogen therapy), vulvovaginal atrophy remained significant (prevalence odds ratios; depression 1.23, major depressive disorder 1.22, anxiety 1.39; all P < 0.0001)., Conclusions: Vulvovaginal atrophy is associated with a significantly higher prevalence/incidence of depression, major depressive disorder, and anxiety. The higher prevalence/incidence and greater differences in younger women highlight the need for a multidisciplinary approach and early diagnosis/management of vulvovaginal atrophy.

Background: Responder analyses are used to determine whether changes that occur during a clinical trial are clinically meaningful; for subjective endpoints such as those based on patient-reported outcomes (PROs), responder analyses are particularly useful., Aim: To identify the minimal clinically important difference (MCID) for selected scores on questionnaires assessing female sexual functioning and to use these differences to analyze the response in a large, controlled, phase 2b, dose-finding study of bremelanotide in premenopausal women with hypoactive sexual desire disorder (HSDD) and mixed HSDD/female sexual arousal disorder (FSAD)., Methods: The responder analyses were performed for the change from baseline to end of study for a total of 7 endpoints. Each PRO endpoint was assessed using at least 1 of 4 types of responder analyses: a planned analysis anchored to MCIDs based on expert estimates (historical anchors); post hoc analyses based on self-reported global benefit; receiver operating characteristic (ROC) curves; and cumulative distribution function. The prespecified analysis groups were all female sexual dysfunction (FSD)-based diagnoses (all study participants), those with HSDD alone, and a combined group of those with FSAD alone plus those with mixed HSDD/FSAD. Post hoc analyses were also performed for subjects with mixed HSDD/FSAD with a primary diagnosis of HSDD., Outcomes: MCIDs based on the ROC curves for changes in Female Sexual Function Index-desire domain, Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) total score, FSDS-DAO item 13 and 14 scores, and number of satisfying sexual events., Results: Outcomes matched those based on input from clinical experts. For all 7 endpoints, responder rates at the 1.75 mg dose in the overall modified intention-to-treat population achieved statistical significance compared with placebo (P ≤ .03)., Clinical Implications: These responder definitions were subsequently used in the bremelanotide phase 3 registration studies (RECONNECT) that evaluated the safety and efficacy of the bremelanotide 1.75 mg subcutaneous dose in premenopausal women with HSDD., Strengths & Limitations: MCIDs for this study were based on changes from a single-blind phase to account for changes due to the placebo effect. These analyses were restricted to a study population composed only of premenopausal women with a clinical diagnosis of HSDD and/or FSAD and were based on data from the same clinical trial., Conclusion: Bremelanotide was safe and well tolerated and demonstrated significant improvement in efficacy vs placebo in the phase 2b trial. The multiple responder analyses offer a valuable approach for determining clinically important effects of bremelanotide for HSDD and FSAD. Althof S, Derogatis LR, Greenberg S, et al. Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide. J Sex Med 2019;16:1226-1235., (Copyright © 2019 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Limited information is available on the performance characteristics of 2 questionnaires commonly used in clinical research, the Psychosexual Daily Questionnaire (PDQ) and the Derogatis Interview for Sexual Function (DISF)-II Assessment, especially in older men with low testosterone (T) and impaired sexual function., Aim: To determine reliability of PDQ and DISF-II by assessing the correlation within and between domains in the questionnaires and to define clinically meaningful changes in sexual activity (PDQ question 4 [Q4]) and desire (DISF-II sexual desire domain [SDD]) domains., Methods: Data from 470 men participating in the T Trials were used to calculate Spearman correlation coefficients of individual items and total score among questionnaires to determine convergent and construct validity. Clinically meaningful changes for sexual desire and activity were determined by randomly dividing the sample into training and validation sets. Anchor- and distribution-based clinically meaningful change criteria were defined in the training set, and selected changes were evaluated in the validation set., Outcomes: Validity of the PDQ and DISF-II and clinically meaningful changes in sexual desire and activity were determined in older men in T Trials., Results: Moderate to strong correlations were shown within and between domains from different questionnaires. Using Patient Global Impression of Change as an anchor, clinically meaningful change in PDQ sexual activity was ≥0.6, and in DISF-SDD was ≥5.0. Applying these change cut-points to the validation set, a greater proportion of T-treated men achieved clinically meaningful improvement in their sexual desire and activity compared to placebo-treated men., Clinical Implications: The PDQ-Q4 and DISF-II-SDD can be used to reliably assess clinically meaningful changes in sexual activity and sexual desire in hypogonadal men treated with T., Strengths & Limitations: Strengths of this study include a large sample size, long trial duration, and inclusion of men with low libido and unequivocally low T levels. Limitations include using data from a single study that enrolled only older hypogonadal men, and only 1 anchor for both sexual desire and activity., Conclusion: Moderate to strong correlations were demonstrated within and between different sexual domains of the PDQ and DISF-II confirming construct and convergent validity. Clinically meaningful improvement in elderly hypogonadal men was change of ≥0.6 score in the PDQ-Q4 and ≥5.0 in the DISF-SDD. Improvements in sexual activity and desire in the T Trials were modest but clinically meaningful. Wang C, Stephens-Shields AJ, DeRogatis LR, et al. Validity and Clinically Meaningful Changes in the Psychosexual Daily Questionnaire and Derogatis Interview for Sexual Function Assessment: Results From the Testosterone Trials. J Sex Med 2018;15:997-1009., (Copyright © 2018. Published by Elsevier Inc.)

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., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The Hypogonadism Impact of Symptoms Questionnaire Short Form (HIS-Q-SF) is a patient-reported outcome measurement designed to evaluate the symptoms of hypogonadism. The HIS-Q-SF is an abbreviated version including17 items from the original 28-item HIS-Q., Aim: To conduct item analyses and reduction, evaluate the psychometric properties of the HIS-Q-SF, and provide guidance on score interpretation., Methods: A 12-week observational longitudinal study of hypogonadal men was conducted as part of the original HIS-Q psychometric evaluation. Participants completed the original HIS-Q every 2 weeks. Blood samples were collected to evaluate testosterone levels. Participants completed the Aging Male's Symptoms Scale, the International Index of Erectile Function, the Short Form-12, and the PROMIS Sexual Activity, Satisfaction with Sex Life, Sleep Disturbance, and Applied Cognition Scales (baseline and weeks 6 and 12). Clinicians completed the Clinical Global Impression of Severity and Change scales and a clinical form., Main Outcome Measures: Item performance was evaluated using descriptive statistics and Rasch analyses. Reliability (internal consistency and test-retest), validity (concurrent and know groups), and responsiveness were assessed., Results: One hundred seventy-seven men participated (mean age = 54.1 years, range = 23-83). Similar to the full HIS-Q, the final abbreviated HIS-Q-SF instrument includes five domains (sexual, energy, sleep, cognition, and mood) with two sexual subdomains (libido and sexual function). For key domains, test-retest reliability was very good, and construct validity was good for all domains. Known-groups validity was demonstrated for all domain scores, subdomain scores, and total score based on the Clinical Global Impression-Severity. All domains and subdomains were responsive to change based on patient-rated anchor questions., Clinical Implications: The HIS-Q-SF could be a useful tool in clinical practice, epidemiologic studies, and other academic research settings., Strengths and Limitations: Careful consideration was given to the selection of the final HIS-Q-SF items based on quantitative data and clinical expert feedback. Overall, the reduced set of items demonstrated strong psychometric properties. Testosterone levels for the participating men were not as low as anticipated, which could have limited the ability to examine the relations between the HIS-Q-SF and testosterone levels. Further, the analyses used data collected through administration of the full HIS-Q, and future studies should administer the standalone HIS-Q-SF to replicate the psychometric analyses reported in the present study., Conclusion: Similar to the original HIS-Q, the HIS-Q-SF has evidence supporting reliability, validity, and responsiveness. The short form includes a smaller set of items that might be more suitable for use in clinical practice or academic research settings. Gelhorn HL, Roberts LJ, Khandelwal N, et al. Psychometric Evaluation of the Hypogonadism Impact of Symptoms Questionnaire Short Form (HIS-Q-SF). J Sex Med 2017;14:1046-1058., (Copyright © 2017 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: This was a Phase I study to evaluate the safety, tolerability, and hemodynamic and pharmacokinetic effects of bremelanotide (BMT) coadministered with ethanol to healthy male and female participants., Methods: This was a randomized, placebo-controlled, double-blind, 3-period, 3-way crossover study. Individuals meeting the inclusion/exclusion criteria received BMT or placebo with or without ethanol at the research facility for 7 consecutive days. Participants were randomized to receive 1 of 6 treatment paths; each participant received single intranasal doses of BMT (20 mg) or placebo on days 1, 4, and 7, with or without oral ethanol (0.6 g/kg) while in a fasted state. The intranasal 20-mg dose of BMT has an exposure equivalent to ~1 to 2 times the subcutaneous dose currently being evaluated in Phase III studies. Vital signs, self-rated sedation scores, nursing and medical observations, and spontaneous reporting by participants provided the basis for evaluation of adverse events. A physical examination and a resting 12-lead electrocardiogram were performed at baseline and on study day 7. Blood and urine samples were obtained for clinical safety profile laboratory tests., Findings: A total of 24 participants were enrolled (12 men; 12 women) and completed the study. Single doses of 20 mg intranasal BMT, administered with or without 0.6 g/kg ethanol, were found to be safe and generally well tolerated with mean maximum ethanol concentrations exceeding 80 mg/dL in women. No clinically significant pharmacokinetic interactions were found between ethanol and BMT either overall or by sex. No significant drug-related hypotensive or orthostatic hypotensive effects were noted. Treatment with BMT did not result in an increased frequency of treatment-emergent adverse events, and no participants discontinued the study because of adverse events. Physical examination, electrocardiography, and laboratory tests disclosed no clinically significant changes., Implications: Female sexual dysfunction is a multifactorial condition with anatomic, physiologic, medical, psychological, and social components. BMT is a synthetic peptide analogue of the naturally occurring hormone α-melanocyte-stimulating hormone and a melanocortin receptor agonist that is being developed for the treatment of hypoactive sexual desire disorder. Its mechanism of action involves activation of endogenous melanocortin hormone pathways involved in the sexual desire and arousal response. The results of this Phase I study found that BMT and ethanol can be safely coadministered and are generally well tolerated with no reports of drug-related serious adverse events. Phase III trials of subcutaneous BMT for the treatment of hypoactive sexual desire disorder in premenopausal women are in progress. ClinicalTrials.gov identifiers NCT02338960 and NCT02333071., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

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: 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.)

Introduction: The Hypogonadism Impact of Symptoms Questionnaire (HIS-Q) is a patient-reported outcome measurement designed to comprehensively evaluate the symptoms of hypogonadism and to detect changes in these symptoms in response to treatment., Aim: To conduct item analysis and reduction, evaluate the psychometric properties of the HIS-Q, and provide guidance on interpreting the instrument score., Methods: A 12-week observational, longitudinal study of hypogonadal men was conducted. Participants completed the HIS-Q every 2 weeks. Blood samples were collected to evaluate testosterone levels. Participants also completed the Aging Male's Symptoms Scale, the International Index of Erectile Function, the Short Form-12 Health Survey, and the Patient-Reported Outcomes Measurement Information System Sexual Activity, Satisfaction with Sex Life, Sleep Disturbance, and Applied Cognition Scales (at baseline and weeks 6 and 12). Clinicians completed the Clinical Global Impression of Severity and Change measurements and a clinical form., Main Outcome Measures: Individual item performance was evaluated using descriptive statistics and Rasch analyses. Reliability (internal consistency and test-retest), validity (concurrent and know groups), and responsiveness were assessed., Results: In total, 177 men participated in the study (mean age = 54.1 years, range = 23-83). The original 53-item draft HIS-Q was reduced to 28 items; the final instrument included five domains (sexual, energy, sleep, cognition, and mood) with two sexual subdomains (libido and sexual function). For all domains, test-retest reliability was acceptable (intraclass correlation coefficients > 0.70), construct validity was good (|r > 0.30| for all comparisons). Known-groups validity was demonstrated for all HIS-Q domain scores, subdomain scores, and the total score as measured by the Clinical Global Impression of Severity, and total testosterone level at baseline (P < .05 for all comparisons). All domains and subdomains were responsive to change based on patient-rated anchor questions (P < .05 for all comparisons)., Conclusion: The final 28-item HIS-Q is reliable, valid, and responsive. The HIS-Q is suitable for inclusion in future clinical trials to help characterize the effects of testosterone replacement therapy., (Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.)

Aim: Evaluate efficacy/safety of bremelanotide (BMT), a melanocortin-receptor-4 agonist, to treat female sexual dysfunctions in premenopausal women., Methods: Patients randomized to receive placebo or BMT 0.75, 1.25 or 1.75 mg self-administered subcutaneously, as desired, over 12 weeks. Primary end point was change in satisfying sexual events/month. Secondary end points included total score changes on female sexual function index and female sexual distress scale-desire/arousal/orgasm., Results: Efficacy data, n = 327. For 1.25/1.75-mg pooled versus placebo, mean changes from baseline to study end were +0.7 versus +0.2 satisfying sexual events/month (p = 0.0180), +3.6 versus +1.9 female sexual function index total score (p = 0.0017), -11.1 versus -6.8 female sexual distress scale-desire/arousal/orgasm total score (p = 0.0014). Adverse events: nausea, flushing, headache., Conclusion: In premenopausal women with female sexual dysfunctions, self-administered, as desired, subcutaneous BMT was safe, effective, and well tolerated (NCT01382719).

Background: Hypogonadism, or low testosterone, is a common disorder. There are currently no patient-reported outcome (PRO) instruments designed to comprehensively evaluate the symptoms of hypogonadism and to detect changes in these symptoms in response to treatment., Objective: The purpose of this study was to develop a PRO instrument, the Hypogonadism Impact of Symptoms Questionnaire (HIS-Q) and to assess its content validity., Methods: A literature review, expert clinician input, and qualitative concept elicitation with 39 male hypogonadism patients (four focus groups: n = 25; individual interviews: n = 14; mean age 52.3 ± 14.3 years) from the USA were used to develop the draft HIS-Q. Subsequent cognitive interviews (n = 29; mean age 51.5 ± 15.4 years) were used to evaluate content validity., Results: Emergent discussion with participants yielded symptoms within the sexual, physical, energy, sleep, cognition, and mood domains. Low libido and tiredness were most commonly reported. The initial version of the HIS-Q includes 53 items that were consistently understood by the participants, who found the instrument to be relevant to their experiences with hypogonadism and comprehensive in the content coverage of symptoms., Conclusion: The HIS-Q is a comprehensive PRO measure of hypogonadism symptom severity in males. Its design elements, including the response options and recall period, were suitable, and content validity was confirmed.

Objective: To create and evaluate a psychometric instrument that measures the impact of experiencing priapism from the patient perspective., Methods: The research protocol consisted of several phases as follows: (1) generating items, (2) composing a patient questionnaire, (3) administering the questionnaire to patients with both active and remitted (≥1 year without priapism episodes) histories of priapism, (4) performing internal consistency and criterion-oriented validity analyses in correlation with clinical histories and erectile function assessment tools, and (5) ascertaining psychometric properties of the instrument., Results: The final instrument comprised a 12-item Priapism Impact Profile (PIP) questionnaire, representing the following 3 domains adversely impacted by priapism: quality of life (QoL), sexual function (SF), and physical wellness (PW), with higher scores indicating inferior experience in respective domains. Internal consistency reliability coefficients for the total PIP score and the 3 domain scores were >0.75. Fifty-four patients (mean age, 31.7 ± 11.4 years) completed the questionnaire. Patients with active priapism (n = 42) had higher total, QoL, SF, and PW scores than those with priapism remission (n = 8; P <.05, P <.05, P = .09, and P <.01, respectively). Patients with a history of recurrent priapism episodes >2 hours in duration had higher total, QoL, SF, and PW scores than those with "very minor" priapism recurrences (≤2 hours in duration; P <.01, P <.01, P <.05, and P <.001, respectively). Patients with "mild-to-moderate" to "severe" erectile dysfunction had higher total, QoL, SF, and PW scores than those with no or "mild" erectile dysfunction (P <.05, P = .14, P <.01, and P = .25, respectively)., Conclusion: The PIP questionnaire is a novel psychometric instrument that offers a means to quantify the adverse health impact of the patient's experience with priapism., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Introduction: Several tools for the assessment of sexuality-related distress are now available. The Female Sexual Distress Scale (FSDS) and its revised version (FSDS-R) are extensively validated and among the most widely used tools to measure sexually related personal distress., Aim: The aim of the study was to determine the psychometric properties of the Iranian version of the FSDS-R in a population sample of Iranian women., Methods: A total of 2,400 married and potentially sexually active women were recruited and categorized into three groups including (i) a healthy control group; (ii) a group of women with hypoactive sexual desire disorder (HSDD); and (iii) a group of women suffering from other female sexual dysfunction (FSD). Participants were asked to complete a set of questionnaires including the Iranian version of the Female Sexual Function Index (FSFI-IV), the FSDS-R, and the Hospital Anxiety and Depression Scale., Main Outcome Measures: Sexuality-related distress and FSD as assessed by the Iranian version of the FSDS-R and the FSFI-IV are the main outcome measures., Results: Internal consistencies and test-retest reliability of the FSDS-R across the three assessments points for the three groups were >0.70. The FSDS-R correlated significantly with anxiety, depression, and the FSFI total score. Significant differences in the FSDS-R scores were found between healthy women, women with HSDD, and women with other types of FSD. Factor analysis of the FSDS-R yielded a single-factor model with an acceptable fit., Conclusions: The Persian version of the FSDS-R is a valid and reliable instrument for the assessment of sexuality-related distress in Iranian women and can be used to screen patients with HSDD., (© 2014 International Society for Sexual Medicine.)

The effect of type and severity of depression on sexual functioning was examined before treatment in 591 men with Major Depression (MDD) or Atypical Depression, as determined by percentage of subjects meeting Diagnostic and Statistical Manual, 4th Edition (DSM-IV) sexual dysfunction criteria (A and B only), and percentage with Derogatis Inventory of Sexual Function (DISF) scores greater than 1 standard deviation below normal. Sexual dysfunction rates were higher for MDD than for Atypical Depression. Depression affected DISF domains differently: orgasm was most impaired, whereas sexual desire was preserved. More severe depression resulted in greater sexual dysfunction.

Introduction: Hypoactive Sexual Desire Disorder (HSDD) is characterized by low sexual desire that causes marked distress or interpersonal difficulty., Aim: The aim of this study was to assess the efficacy and safety of the 5-HT1A agonist/5-HT2A antagonist flibanserin in premenopausal women with HSDD., Methods: This was a randomized, placebo-controlled trial in which premenopausal women with HSDD (mean age: 36.6 years) were treated with flibanserin 100 mg once daily at bedtime (qhs) (n = 542) or placebo (n = 545) for 24 weeks., Main Outcome Measures: Coprimary end points were the change from baseline to study end in Female Sexual Function Index (FSFI) desire domain score and in number of satisfying sexual events (SSE) over 28 days. Secondary end points included the change from baseline in FSFI total score, Female Sexual Distress Scale-Revised (FSDS-R) total score, and FSDS-R Item 13 score., Results: Compared with placebo, flibanserin led to increases in mean (standard deviation) SSE of 2.5 (4.6) vs. 1.5 (4.5), mean (standard error [SE]) FSFI desire domain score of 1.0 (0.1) vs. 0.7 (0.1), and mean (SE) FSFI total score of 5.3 (0.3) vs. 3.5 (0.3); and decreases in mean (SE) FSDS-R Item 13 score of -1.0 (0.1) vs. -0.7 (0.1) and mean (SE) FSDS-R total score of -9.4 (0.6) vs. -6.1 (0.6); all P ≤ 0.0001. The most frequently reported adverse events in the flibanserin group were somnolence, dizziness, and nausea, with adverse events leading to discontinuation in 9.6% of women receiving flibanserin vs. 3.7% on placebo., Conclusion: In premenopausal women with HSDD, flibanserin 100 mg qhs resulted in significant improvements in the number of SSE and sexual desire (FSFI desire domain score) vs. placebo. Flibanserin was associated with significant reductions in distress associated with sexual dysfunction (FSDS-R total score) and distress associated with low sexual desire (FSDS-R Item 13) vs. placebo. There were no significant safety concerns associated with the use of flibanserin for 24 weeks., (© 2013 International Society for Sexual Medicine.)

Introduction: Brotto proposes to combine female sexual desire and arousal disorders in the Diagnostic and Statistical Manual of Mental Disorders, fifth edition., Aim: We provide evidence that the proposed criteria could potentially exclude from diagnosis or treatment a large number of women with distressing dysfunction in sexual arousal., Methods: Rating scale data from nontreatment validation studies of patient-reported outcome measures including almost 500 women in North America and Europe, including 49 women diagnosed with arousal disorder only, were compared with the proposed criteria., Main Outcome Measures: The main measures were an early version of the eDiary (an electronic diary on sexual activity) and four previously validated measures of female sexual dysfunction (FSD), the clinician-rated Sexual Interest and Desire Inventory-Female and the self-rated Female Sexual Function Index, Changes in Sexual Functioning Questionnaire, and Female Sexual Distress Scale. Results.  The women with female sexual arousal disorder (FSAD) scored as manifestly sexually dysfunctional and significantly sexually distressed. They had fewer satisfying sexual events (SSEs) vs. women with no FSD, with a lower proportion of SSEs, and significantly fewer orgasms., Conclusion: Despite evidence presented that women with FSAD have clinically disordered sexual function, our data also suggest that the majority of these women with FSAD would meet none of the six proposed "A" criteria for Sexual Interest/Arousal Disorder, raising new validity and utility concerns for the proposed diagnostic classification. Suggestions are made to modify the proposed new criteria so as to include such distressed women., (© 2012 International Society for Sexual Medicine.)

Introduction: Combining female sexual desire and arousal disorders is proposed for the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Brotto et al. challenged our findings that the proposed criteria could potentially exclude from diagnosis or treatment a large number of women with distressing loss of function or in sexual desire, because (i) our samples were insufficiently severe; (ii) we sought to retain the current diagnostic criteria, whereas they contend that "the bar should be raised"; and (iii) the current sexual function diagnostic criteria are unreliable., Aim: Here we provide additional data to support our view suggesting that the proposed criteria would potentially exclude large numbers of women from diagnosis or treatment if they have moderate-to-marked (rather than severe) hypoactive sexual desire disorder (HSDD), or HSDD with incomplete loss of receptivity., Methods: In nontreatment validation studies of 481 women in North America and Europe, 231 women diagnosed with HSDD only were compared to women with no female sexual desire., Main Outcome Measures: Clinicians experienced in sexual medicine determined the severity of HSDD using the standard Clinical Global Impression of Severity. Rating scale data were also used, including the clinician-rated Sexual Desire and Interest Inventory-Female and the self-rated Female Sexual Function Index, Changes in Sexual Functioning Questionnaire, Female Sexual Distress Scale, and an e-Diary about desire during sexual events., Results: The severity of the HSDD was rated by clinicians as generally moderate-to-marked, not mild. The women with HSDD scored as manifestly sexually dysfunctional and significantly sexually distressed, and reported markedly fewer satisfying sexual events compared to age-matched, non-dysfunctional controls, even for those with moderate or milder degrees of severity, providing compelling evidence that our sample of women with HSDD had clinically disordered sexual function. Yet the proposed criteria would apparently allow diagnosis (and therefore treatment) of only severe desire dysfunction., Conclusion: It would be counterproductive to combine the two disorders, to make individual criteria for the disorders more stringent or to require more such criteria for a diagnosis because such disorders tend to be distinct in presentation, in treatability with currently available therapies, and in logical approaches to be tested to improve therapy., (© 2012 International Society for Sexual Medicine.)

Background: Hypoactive sexual desire disorder (HSDD) has been estimated to occur in 10%-15% of adult women in large population-representative and community-based studies. However, none of these studies have used in-person diagnostic interview assessment to rule out alternative diagnoses, nor has the impact of other health conditions or help-seeking experiences been investigated. The current study aimed to determine the prevalence of generalized acquired HSDD in women aged ≥18 who attended primary care or obstetrics and gynecology clinics for nonurgent clinic visits in the United States., Methods: A total of 701 women were enrolled at 20 clinical sites across the United States between June 11, 2010, and October 15, 2010. Participants completed a two-part self-administered questionnaire, and a validated, structured, in-person diagnostic interview, conducted by a trained health professional was used for diagnosing HSDD according to DSM-IV-TR criteria., Results: Fifty-two women (7.4%) were assigned a diagnosis of generalized acquired HSDD. Prevalence was lower in minority and postmenopausal women. Level of education and other sociodemographic factors did not appear to differentiate between women with and without HSDD. A marked increase in HSDD prevalence was noted in the perimenopausal (i.e., 40-49 years) and immediate postmenopausal (i.e., 50-59) age groups. Of the women diagnosed with HSDD, 53% had sought care from a health professional for HSDD., Conclusions: In this sample of women recruited in the clinical care setting, we observed an overall prevalence rate of 7.4% of acquired, generalized HSDD, with markedly increased prevalence in midlife women.

Introduction: Hypoactive sexual desire disorder (HSDD) is the most common form of female sexual dysfunction and is characterized by low sexual desire that causes distress., Aim: The aim of this study was to assess the efficacy and safety of flibanserin, a postsynaptic 5-HT(1A) agonist/5-HT(2A) antagonist, in premenopausal women with HSDD., Methods: North American premenopausal women with HSDD were randomized to 24 weeks' treatment with placebo (N = 295), flibanserin 50 mg (N = 295), or flibanserin 100 mg (N = 290), once daily at bedtime., Main Outcome Measures: Coprimary endpoints were change from baseline to study end in number of satisfying sexual events (SSE) and sexual desire score measured daily using an electronic diary (eDiary). Secondary endpoints included change from baseline to study end in female sexual function index (FSFI) desire domain and total scores, female sexual distress scale-revised (FSDS-R) Item 13 and total scores, and patient's global impression of improvement., Results: Flibanserin 50 mg and 100 mg led to increases in SSE (P < 0.05 and P < 0.01 vs. placebo, respectively). There was a numerical trend toward improvement in eDiary desire score on flibanserin 100 mg, but statistical significance was not reached (P = 0.07 vs. placebo). FSFI desire domain and total scores increased with both flibanserin regimens (P < 0.05). FSDS-R total and Item 13 scores decreased with flibanserin 100 mg (P < 0.001), indicating reduced sexual distress. More women receiving flibanserin 50 mg and 100 mg considered their HSDD to have improved than women receiving placebo (39.6% and 50.0% vs. 30.3%, respectively) (P < 0.05)., Conclusion: In premenopausal women with HSDD, flibanserin 50 mg and 100 mg once daily at bedtime were well tolerated and associated with statistically significant improvements in SSE, sexual desire (FSFI desire domain score but not eDiary desire score) and overall sexual function, and reduction of sexual distress, vs. placebo., (© 2012 International Society for Sexual Medicine.)

Introduction: Sexual dysfunction is common in patients with major depressive disorder (MDD). Antidepressant medications especially the selective serotonin reuptake inhibitors (SSRIs) may improve depressive symptoms but further decrease sexual function. Gepirone extended release (gepirone-ER) differs from the SSRIs in only affecting the 5-HT(1A) receptor and has demonstrated efficacy in treatment of depression and sexual dysfunction in depressed women. This report describes the effect of gepirone-ER on sexual function in depressed men., Aim: The aims of this article were to study the effects of gepirone-ER on sexual function in men with MDD and to determine if positive effects are independent of antidepressant or anxiolytic activity., Main Outcome Measures: The main outcome measures of this article were Hamilton depression rating scale (HAMD-17), and changes in sexual functioning questionnaire (CSFQ)., Methods: In an 8-week study, gepirone-ER, placebo, or fluoxetine were administered in a double-blind fashion to 181 depressed men. The CSFQ results were used to determine quality of sexual function. To test for an antidepressant or anxiolytic effect, a 50% reduction in HAMD-17 score separated antidepressant responders from nonresponders, and item 12 of the HAMD scale (psychic anxiety) scores of 0 or 1 separated anxiolytic responders from nonresponders., Results: Gepirone-ER treatment improved total sexual function compared with placebo measured by the CSFQ at weeks 4 (P=0.012) and 8 (P=0.046). At 4 weeks, almost every CSFQ domain is improved. The orgasm domain was especially improved, 67% by week 4. Gepirone-ER antidepressant and anxiolytic nonresponders showed significant improvement in sexual function. Fluoxetine treatment did not produce improvement. In fact, fluoxetine-treated subjects had lower scores on the total CSFQ, less than placebo, and significantly less than gepirone-ER., Conclusion: Gepirone-ER improves sexual dysfunction in depressed men. All domains of sexual function improved. Gepirone-ER has a pro-sexual effect independent of antidepressant or anxiolytic activity., (© 2012 International Society for Sexual Medicine.)

Introduction: Several methods have been so far proposed to compare the effectiveness of the three available phosphodiesterase type 5 inhibitors (PDE5Is)., Methods: Two urologists (E.C. and G.B.B.), together with the Controversy's Editor (E.A.J.), with expertise in the area of medical treatment of erectile dysfunction (ED) present the various perspectives on the evaluation of PDE5Is in ED. The use of the most popular psychometric tool, the International Index of Erectile Function, is presented by an expert psychologist (L.R.D.)., Main Outcome Measures: Expert opinion supported by the critical review of the currently available literature., Results: Trials have demonstrated that the PDE5Is are excellent drugs with a great specificity of action and an almost perfect tolerance profile. Some instruments for comparison of clinical efficacy have to be considered subjective (psychometry, patient's preference, changes in quality of general, or sexual life). Some others are more objective (hardness, hormonal levels, and local circulation). An evidence-based comparison of the three PDE5Is should in the future be rooted in both subjective and objective methods. This will be of paramount importance in the drug trial design of new, forthcoming PDE5Is., Conclusions: Comparison between PDE5Is using both subjective and objective parameters will permit to individuate, on the basis of the evidence, the subset of couples where one drug, or one dose, or dose regimen, is to be considered of first choice., (© 2012 International Society for Sexual Medicine.)

Sex-related distress is integral to the diagnosis of hypoactive sexual desire disorder (HSDD). This article describes the results of three prospective, non-treatment validation studies (two North American and one European), each testing over 200 participants with HSDD, other types of female sexual dysfunction (FSD), or no FSD in which the 12-item Female Sexual Distress Scale(©) (FSDS(©)), the 13-item FSDS-Revised(©)(FSDS-R(©)), and a single question asked using a daily electronic diary (the eDiary For HSDD Trials(©); eDiary) were used to measure sex-related distress. FSDS results with 30- and seven-day recall were equivalent. The results observed with FSDS-R Item 13 (a single question assessing concern due to low sexual desire) were comparable to the FSDS. Mean eDiary monthly distress scores were closer to the minimum possible score (equivalent to "a little bit" of distress) and were about twice as variable as FSDS or FSDS-R Item 13 scores in participants with HSDD. All three measures confirmed that there is more distress in women with HSDD compared to women with no sexual dysfunction at all time points, demonstrating discriminant validity.

Introduction: Gepirone-extended release (ER) is effective in treating hypoactive sexual desire disorder (HSDD), as measured by the percent of females with HSDD that no longer met criteria for HSDD treatment. Another approach is to determine treatment effect on sexual desire using a recognized rating scale for sexual function. Because gepirone-ER has antidepressant and anxiolytic effects, investigation of these effects on sexual desire is appropriate., Aim: The aim of this study was to determine whether gepirone-ER has positive effects on sexual desire as measured by the DeRogatis Inventory of Sexual Function (DISF) in a post hoc analysis of 8- and 24-week studies and if this gepirone effect is independent of its antidepressant or anxiolytic activity., Main Outcome Measures: The main outcome measures used for this study were the Hamilton Depression Rating Scale (HAMD-25), change from baseline (CFB), and DISF CFB., Methods: Three hundred thirty-four women selected for depressive symptoms, not sexual dysfunction, received gepirone-ER (40-80 mg/day) in a controlled study of atypical depression using the HAMD-25 to measure antidepressant efficacy and a DISF subscale (domain I) to measure sexual cognition/fantasy (desire). After treatment, a 50% reduction from baseline HAMD-25 score identified antidepressant responders. Item 12 of HAMD scale (psychic anxiety) was used to define anxiolytic response scores of 0, 1 as responders, and scores of 2, 3, and 4 as nonresponders., Results: Gepirone-ER had no significant antidepressant or an anxiolytic effect in study 134006; however, DISF results demonstrate that gepirone-ER improves sexual desire in short term (P=0.043) and long term (P=0.006). Both gepirone-ER antidepressant and anxiolytic responders have statistically significant improved sexual desire. Gepirone-ER antidepressant and anxiolytic nonresponders also show statistically significant improvement., Conclusions: In depressed women, gepirone-ER has three mechanisms of action affecting sexual desire: an antidepressant effect, an anxiolytic effect, and a pro-sexual effect. Gepirone-ER improves sexual desire from the 24th to the 50th percentile according to population norms for the DISF., (© 2011 International Society for Sexual Medicine.)

Introduction: The Female Sexual Function Index (FSFI) has consistently been shown to have discriminant validity, test-retest reliability, and internal consistency as a measure of female sexual function. However, the content validity (relevance, clarity, comprehensiveness) of the instrument in women with hypoactive sexual desire disorder (HSDD) must also be established., Aim: The aim of this study were to assess the content validity of the FSFI, specifically the FSFI desire domain, in pre- and postmenopausal women with HSDD., Methods: Two single-visit content validation studies were conducted in the United States. Eligible premenopausal (both studies) and postmenopausal (second study only) women with HSDD completed the FSFI followed by one-on-one, face-to-face cognitive debriefing interviews including open-ended questions to capture information on their perceptions of the instrument. Information on women's experiences of decreased sexual desire was also captured., Main Outcome Measures: The main outcome measures of this study were the women's ratings of the clarity, ease of understanding, comprehensiveness, and relevance of the 19 items of the FSFI., Results: Interviews with 15 premenopausal women (first study), and 30 pre- and 31 postmenopausal women (second study), were analyzed. Across the whole sample, most women (80-100%) found every item of the FSFI clear and easy to understand. The majority (53-70%) felt that the FSFI captured all their feelings about decreased sexual desire and other sexual problems, and most (84-90%) indicated that additional questions were unnecessary. Most women in both studies (93-100%) reported that the two items comprising the FSFI desire domain were clear, easy to understand, and were relevant to them. The majority of women thought that a recall period of ≥7 days is most relevant for recall of their sexual desire., Conclusions: These studies establish the content validity of the FSFI in pre- and postmenopausal women with HSDD, supporting the use of this instrument as a measure of sexual function in women with this condition., (© 2011 International Society for Sexual Medicine.)

Introduction: There is currently no Food and Drug Administration (FDA)-approved treatment for hypoactive sexual desire disorder (HSDD). FDA approval of products utilizing testosterone has been delayed due to possible safety concerns. Flibanserin, a 5-HT(1A) agonist, 5-HT(2) antagonist, and gepirone-ER, a 5-HT(1A) agonist, have been shown to have activity in treatment of HSDD. However, more recently, the FDA issued a non-approval letter for flibanserin., Aim: To study the effect of gepirone-ER on HSDD in women with major depressive disorder (MDD)., Methods: At baseline and post-treatment visits, a trained psychiatrist made diagnoses of HSDD based on Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria. Subjects meeting criteria for HSDD were followed to observe the effect of gepirone-ER (20-80 mg/day), comparator antidepressants (fluoxetine, 20-40 mg/day or paroxetine, 10-40 mg/day), or placebo in reversing DSM-IV diagnosis. A subpopulation of women with Hamilton Depression Rating Scale (HAMD-17) entry scores of 18 or less was evaluated. Adverse events (AEs) of sexual dysfunction were also collected., Main Outcome Measure: Number (%) of patients who no longer met criteria for HSDD (percent resolved)., Results: Eight hundred seventy-five women (18-64 years of age, average 38 years old, ∼80% premenopausal) entered three studies; 668 (72.5%) completed. Only 161 (18.4%) met DSM-IV criteria for HSDD. Cumulatively, 63% of gepirone-ER-treated patients reversed their diagnosis of HSDD compared to 40% of placebo-treated patients at end point (8 weeks) (P = 0.007). Selective serotonin reuptake inhibitor-treated patients were not different from placebo. Significant results for gepirone-ER occurred by week 2 (P = 0.0001). Patients who were mildly depressed (HAMD scores of 18 or less) also improved at week 2 (P = 0.01) and week 8 (P = 0.07). Sexual dysfunction AEs were significantly less in gepirone-ER-treated patients than placebo (P = 0.013)., Conclusions: Gepirone-ER may have efficacy in the treatment of HSDD among depressed and possibly nondepressed women. Efficacy occurs by week 2, and does not seem to be purely an antidepressant effect., (© 2011 International Society for Sexual Medicine.)

This study evaluated safety and efficacy of esterified estrogens and methyltestosterone administered alone or in combination for the treatment of hot flashes in menopausal women. The 0.30-mg esterified estrogens and 0.30-mg methyltestosterone combination was the lowest effective dose, and our results are consistent with the known safety profile of estrogen and androgen combination products., (Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Introduction: The American Psychiatric Association recommends considering sexually related personal distress when assessing female sexual dysfunction. Currently, there is little data regarding the impact of sexual complaints on sexual distress., Aim: To investigate the association between sexual complaints and perceived sexual distress in a population of ambulatory adult women., Methods: Using the short forms of the Personal Experiences Questionnaire and Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire, we assessed sexual complaints among 305 women seeking outpatient gynecologic care. Depressive symptoms were quantified using the Center for Epidemiologic Studies Depression (CESD) score. Sexual distress was measured using the Female Sexual Distress Scale (FSDS). Using multivariable logistic regression, we compared sexual complaints between distressed and nondistressed women., Main Outcome Measures: Sexual distress, defined by FSDS score ≥15., Results: FSDS scores were available for 292/305 participants. Seventy-six (26%) scores reflected distress. Distressed women were more likely to be younger (55.2±1.0 years vs. 56.7±0.8 years, P=0.017); have higher CESD scores (16.6 vs. 9.5, P=0.001); and report decreased arousal (56.8% vs. 25.1%, P=0.001), infrequent orgasm (54% vs. 28.8%, P=0.001), and dyspareunia (39.7% vs. 10.6%, P=0.001). Women with sexual distress were also more likely to report sexual difficulty related to pelvic floor symptoms, including urinary incontinence with sexual activity (9% vs. 1.3%, P=0.005), sexual avoidance due to vaginal prolapse (13.9% vs. 1%, P=0.001), or sexual activity restriction due to fear of urinary incontinence (14.9% vs. 0.5%, P=0.001). After multivariate analysis, sexual distress was significantly associated with dyspareunia (odds ratio [OR] 3.11, P=0.008) and depression score (OR 1.05, P=0.006), and inversely associated with feelings of arousal during sex (OR 0.19, P=0.001)., Conclusion: Our results indicate that sexually related personal distress is significantly associated with dyspareunia, depressive symptoms, and decreased arousal during sexual activity. This contributes to our understanding of how sexual complaints may adversely affect women's quality of life., (© 2010 International Society for Sexual Medicine.)

Background: Androgen deficiency is increasingly recognized in young male cancer survivors; however, its impact on quality of life (QOL) is not established. The authors investigated the relationship between androgen levels, QOL, self-esteem, fatigue, and sexual function in young male cancer survivors compared with control subjects., Methods: A cross-sectional, observational study of 176 male cancer survivors and 213 male controls aged 25 to 45 years was performed. Subjects completed 3 QOL scales (Medical Outcomes Study 36-Item Short-Form Health Survey version 2, the 12-item General Health Questionnaire [GHQ-12], and Aging Male Scale), and measures of self-esteem (Rosenberg Self-Esteem Scale), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue), and sexual function (Derogatis Interview for Sexual Functioning-II Self-Report-Male)., Results: Cancer survivors had lower scores for all components of the Short-Form Health Survey, Aging Male Scale, and Functional Assessment of Chronic Illness Therapy-Fatigue, and for 4 of 5 subsections of the Derogatis Interview for Sexual Functioning than controls. The majority of these differences remained after adjusting by linear regression analysis. Levels of psychiatric disorder or self-esteem did not differ between the 2 groups. In cancer survivors, those with androgen deficiency (serum testosterone < or = 10 nmol/L) had lower scores than those without for all components of the Short-Form Health Survey, the General Health Questionnaire, Functional Assessment of Chronic Illness Therapy-Fatigue, and the Derogatis Interview for Sexual Functioning. Serum testosterone only weakly correlated with health measures., Conclusions: Young male cancer survivors self-report a marked impairment in QOL, energy levels, and quality of sexual functioning, and this was exacerbated in those with androgen deficiency. However, psychological distress was not elevated, self-esteem was normal, and sexual relationships were not impaired. The relationship with testosterone is complex, and appears dependent on a threshold level rather than direct correlation. Interventional trials are needed to determine whether testosterone replacement would improve QOL in young male cancer survivors.

Introduction: Currently, there is no clear standard assessment tool for the diagnosis and daily monitoring of hypoactive sexual desire disorder (HSDD) in postmenopausal women., Aim: The aim of the study was to validate (i) the Women's Sexual Interest Diagnostic Interview-Short Form (WSID-SF) which is a structured tool to identify HSDD; and (ii) the Daily Log of Sexual Activities (DLSA) which is a diary to monitor daily HSDD status in postmenopausal women. Both assessments were collected as self-reports by an interactive voice response system (IVRS)., Methods: At the initial study visit, 629 postmenopausal women, age 39-66, were evaluated for HSDD by the WSID-SF. In addition, in a subgroup of 175 subjects at five study sites, HSDD was assessed by physicians who were blinded to the WSID-SF diagnosis. During the 58-day study period, patients completed the DLSA daily through self-reported IVRS. All women also completed the Female Sexual Function Index (FSFI), Menopause Sexual Interest Questionnaire (MSIQ), Female Sexual Distress Scale (FSDS), Dyadic Adjustment Scale (DAS), and Kellner Symptom Questionnaire (KSQ) at both the initial study visit and at the end of the study. The WSID-SF-based identifications were compared with clinical diagnoses made based on physicians' clinical experience. Construct validity of the WSID-SF and DLSA were assessed based on comparisons with questionnaire results. Internal consistency and test-retest reliability of the DLSA were also evaluated., Main Outcome Measures: Main outcome measures include the agreement between WSID-SF diagnosis and clinician diagnosis, convergent and divergent validity of the WSID-SF and DLSA, and reliability of the DLSA. Results. Enrolled subjects were classified into HSDD (N = 468) and non-HSDD (N = 161) groups by WSID-SF. When compared with physician's diagnosis, WSID-SF-based diagnosis had a specificity of 89% and a sensitivity of 70% (kappa = 0.46, P < 0.001). WSID-SF showed significant correlation with each domain of the FSFI, MSIQ, and FSDS (all P < 0.001). As anticipated, WSID-SF had low or nonsignificant correlations with all domains of the DAS and the KSQ. Four different algorithms were piloted to calculate DLSA scores. Data on the detailed analysis conducted to evaluate the four scoring strategies is on file (not presented in this article). Ultimately, the weekly DLSA total score calculated by algorithm #4 was selected to validate the DLSA. In the test-retest reliability evaluation, the intraclass correlation coefficient was 0.80 for women with HSDD and 0.84 for women without HSDD (P < 0.001 for all analysis). In the known-group validity comparison, the weekly DLSA total score was significantly different (P < 0.001) among the HSDD and the no HSDD groups, with an effect size of 0.89-0.92 based on Cohen's d. The DLSA also showed convergent validity with moderate to high correlations with each domain of the FSFI, MSIQ, and FSDS (P < 0.001 for all correlations). As anticipated, the DLSA had weak correlations with the DAS and KSQ demonstrating divergent validity., Conclusions: The WSID-SF had good specificity and sensitivity (i.e., discriminative validity) in identifying HSDD in postmenopausal women. In addition, the DLSA is a reliable and valid patient-reported outcomes tool that can be utilized to assess effectiveness of treatments in postmenopausal women with HSDD. Further, the WSID-SF and DLSA both demonstrated good convergent and divergent validity.

Introduction: The challenge in the field of sexual medicine is to develop evidence-based principles for clinical evaluation and create a uniform, widely accepted diagnostic and treatment approach for all sexual problems and dysfunctions, for both genders., Aim: To provide recommendations for the broad approach for assessing sexual problems in a medical practice setting; to develop an evidence-based diagnostic and treatment algorithm for men and women with sexual dysfunctions., Methods: The PubMed literature was reviewed. Expert opinion was based on the grading of evidence-based medical literature and the Delphi consensus process., Results: The Committee determined three principles for clinical evaluation and management: (i) adoption of a patient-centered framework, with emphasis on cultural competence in clinical practice; (ii) application of evidence-based medicine in diagnostic and treatment planning; (iii) use of a unified management approach in evaluating and treating sexual problems in both men and women. The International Consultation in Sexual Medicine-5 stepwise diagnostic and treatment algorithm was developed for that purpose. According to this algorithm, sexual, medical, and psychosocial history is mandatory, whereas physical examination and laboratory tests are highly recommended in most cases. Furthermore, the Brief Sexual Symptom Checklist (BSSC) for Men and BSSC for Women, and more recently the Sexual Complaints Screener (SCS) for Men and SCS for Women, were all endorsed for screening purposes. A classification system was also defined; clinically, sexual dysfunctions are categorized in three types according to their etiology (Type I: psychogenic; Type II: organic; Type III: mixed). Final recommendations on specialized diagnostic tests were based on level of evidence., Conclusions: A unified diagnostic and management strategy in sexual medicine, irrespective of condition and gender, would improve patients' sexual well-being. It would also lead to the development of academic curricula to provide practicing physicians across specialties with the needed skills to meet contemporary patients' needs in sexual medicine health-care delivery.

Introduction: Transdermal testosterone patch (TTP) treatment produced statistically significant improvements in a satisfying sexual activity (SSA), sexual desire, and personal distress in postmenopausal women suffering from hypoactive sexual desire disorder (HSDD), but clinical significance of these changes was not determined., Aim: To quantify the magnitude of change in three principal outcomes measures determined by HSDD patients as associated with the perception of meaningful benefit with TTP therapy., Methods: The criteria for defining responders were determined using anchoring methodology and receiver operating characteristics analysis to establish minimum important differences (MIDs) in a representative subsample of 132 patients in two randomized, controlled trials in surgically menopausal women with HSDD (N = 1,094). Perceived benefit was established based upon the question "Overall, would you say that you experienced a meaningful benefit from the study patches?". These data defined responders and established MIDs for changes in sexual desire, SSA, and personal distress. The MIDs were applied to the two trials to establish responder rates in each treatment group., Main Outcome Measures: Changes in score that correspond to the MID for sexual desire, SSA, and personal distress, and responder rates in each treatment group based upon these values., Results: Increases in frequency of SSA of greater than 1 activity/4 weeks, increases in sexual desire score of > or = 8.9, and decreases in the personal distress score of > or = 20.0 were identified as threshold improvements best able to differentiate responders and nonresponders. The responder rate was significantly higher (P < 0.001) in the testosterone group vs. placebo for all three outcomes measures (sexual desire, 50% vs. 34%; SSA, 44% vs. 30%; personal distress, 51% vs. 39%)., Conclusions: Changes in sexual desire, SSA, and personal distress observed with TTP treatment in surgically menopausal women with HSDD were clinically significant and were associated with a meaningful treatment benefit.

Introduction: Female sexual dysfunction (FSD) is a common disorder in postmenopausal women. Currently, there is no clear "gold standard" for the diagnosis of FSD., Aim: The aim of this study was to evaluate the interrater reliability of the Women's Sexual Interest Diagnostic Interview (WSID), a new structured clinical interview designed to diagnose hypoactive sexual desire disorder (HSDD). The reliability of additional interview questions focused on the diagnosis of other types of FSD was also evaluated., Main Outcome Measures: The main outcome measure was the level of agreement in the diagnosis of FSD among clinical experts, between clinical experts and study coordinators, and between clinical experts and patients' self-reported interactive voice response system (IVRS) version of the WSID., Methods: Two versions of WSID were developed based on current diagnostic criteria: a clinician-administered version using a structured interview guide, and a patient self-report version using an IVRS. Three sexual medicine experts developed 20 clinical scenarios portraying cases and noncases of HSDD and other FSD diagnostic subtypes. Ten actresses with experience in standardized patient interviewing rehearsed these scenarios and performed the scripted patient roles in a standardized clinical interview with clinical experts (not the author of the script) and study coordinators, on a one-on-one basis, using the WSID interview format. In addition, all actresses completed the IVRS version of the WSID. Interviews were videotaped and viewed by the expert panel. In each instance, the diagnosis that the interview was scripted to portray was considered as the "gold standard." Kappa (kappa) coefficients were utilized to assess the level of agreement among experts, between study coordinators and the "gold standard", and between the IVRS version of the WSID and the "gold standard"., Results: All experts agreed with the gold standard diagnosis provided by the author of the script (kappa=1.0). Similarly, there was perfect agreement among the experts on the presence of depressive symptomatology (kappa=1.0). On the related diagnoses of arousal disorder, orgasmic disorder, and sexual pain disorder, kappas of 0.894, 0.966, and 0.946 were observed (P<0.0001 for all comparisons). When study coordinator's WSID diagnoses were compared with the "gold standard," kappa for HSDD was 0.851; sensitivity was 0.864, and specificity and positive predictive value (PPV) were 1.00 (P<0.001 for all comparisons). When diagnoses obtained via IVRS interviews were compared with the "gold standard", kappa for HSDD was 0.802, sensitivity was 0.818, and specificity and PPV were 1.00 (P<0.001 for all comparisons)., Conclusion: Agreement as estimated by kappa coefficients was consistently high in both clinician-administered and patient self-reported IVRS versions in the diagnosis of HSDD.

Introduction: Previous, population-based studies investigating the risk factors for sexual distress have not drawn on longitudinal data., Aims: Determine the prevalence of sexual distress and dysfunction, explore factors associated with/predictive of sexual distress, and describe changes in sexual function over a decade in a population-based sample of mid-aged women., Methods: Eleven-year prospective study of Australian-born women, aged 45-55 years, and menstruating at baseline. Short Personal Experiences Questionnaire (SPEQ) was completed in years 1 to 8 and 11 of follow-up. Female Sexual Distress Scale (FSDS) was completed in the 11th year of follow-up., Main Outcome Measures: Validated outcome measures were the SPEQ (total sex score or=15 indicates sexual distress)., Results: Two hundred fifty-seven women were interviewed in the 11th year of follow-up. All domains of sexual function declined significantly in the decade studied. Women using hormone therapy in year 11 had significantly greater responsivity and higher frequency of sexual activities than nonusers. Two hundred four women completed both the FSDS and SPEQ questionnaires. One hundred sixty-six (81%) women had an SPEQ score or=15, and were classified as having female sexual dysfunction. The multiple logistic regression analysis found that female sexual distress was concurrently associated with higher depression scores (odds ratio [OR] 1.31, 95% confidence interval [CI] 1.10, 1.56) and more negative feelings for partner (OR 0.49, 95% CI 0.32, 0.76) and predicted by prior negative feelings for partner (OR 0.31, 95% CI 0.14, 0.70), and a greater decline in total sex score (OR 0.77, 95% CI 0.59, 0.99)., Conclusions: By the end of the sixth decade, women have low levels of sexual function. Hormone therapy may help these women maintain sexual function. A minority of these mostly postmenopausal women are significantly distressed about low sexual function. Sexual distress is associated with depression and relationship factors.

Introduction: Epidemiology can be defined as the population study of the occurrence of health and disease. The knowledge of the rates of occurrence of sexual dysfunctions and the primary risk factors for these conditions is very important to assist in assessing the risk and planning treatment and prevention programs in sexual medicine., Aim: Review modern studies of the prevalence and incidence of sexual dysfunction in an effort to establish a consensus concerning the frequency of occurrence of these conditions, and review the strengths and liabilities of design methodology in the field., Main Outcome Measure: Review of peer-reviewed literature., Results: The findings suggest that sexual dysfunctions are highly prevalent in our society worldwide, and that the occurrence of sexual dysfunctions increases directly with age for both men and women. There is also a strong support for the finding that although the frequency of symptoms increases with age, personal distress about those symptoms appears to diminish as individuals become older. An additional uniform result was that specific medical conditions and health behaviors represent major risk factors for sexual disorders, and that many of these health conditions also have a strong positive relationship with age., Conclusions: Progress has been made concerning both the number and quality of epidemiologic prevalence studies in sexual medicine; however, there is a paucity of studies of the incidence of these conditions. Because reliable incidence data are critical for prevention and treatment planning, the design and execution of the incidence trials should become a high priority for the field. In addition, repeated calls for the development of a new systematic and integrated diagnostic system in sexual medicine were also evident, because of the perception by many that the imprecision of our current diagnostic system represents the "rate-limiting step" for the epidemiology of the field. The review suggests that although much has been accomplished in the past 15-20 years, much remains to be done.

Evaluations of the nature of an individual's sexual functioning are done with relative frequency in today's clinical healthcare environment, often prompted by sequelae of a medical disorder (e.g. diabetes, breast cancer), surgical procedure (e.g. bilateral oophorectomy), or prescribed medications (SSRI antidepressant, antihypertensive). In addition, an increasingly large number of evaluations of sexual functioning are done in association with clinical trials research in the rapidly emerging field of sexual medicine. Although clinical and research assessments of sexual functioning share many similarities, they can also be quite different, with distinct perspectives and goals regarding the assessment process. Research evaluations tend to be narrowly focused on an index condition, with highly defined patient characteristics, and long lists of inclusion/exclusion criteria. Treatment regimens are defined by research protocol a priori, and assigned through randomization, with few options for alternatives. The process results in a rigorously defined sample of patients, but one that may be hard to generalize from to real world clinical reality. Clinical sexual evaluations, on the other hand, tend to arise in a much broader health context. There are no exclusionary patient characteristics; medical, psychological, and relationship complexities all form the context in which the patient's sexual functioning occurs, and must be factored in to the clinical evaluation and treatment recommendations. Regardless of which context gives rise to the evaluation, there are three basic sources of data that we draw from: psychometric assessment, clinical interview and laboratory assays. The clinician doing a sexual evaluation must assimilate and integrate the data from these three sources in an iterative process and arrive at a cogent diagnosis and treatment plan.

The recent recognition of the high prevalence of sexual dysfunctions and disorders in our society, along with the substantial investment of the pharmaceutical industry in the field of sexual functioning, has resulted in a significant expansion in the development of valid and reliable measures of sexual function/dysfunction. The instruments tend to be brief self-report inventories, typically requiring 10-20 min of patient time for completion. Most measures were initially developed as screening and outcomes measures for use in clinical drug trials of new treatments for sexual dysfunction, but are beginning to see more widespread use in the clinic. All these instruments must adhere to recently prescribed rigorous guidelines set forth by the Food and Drug Administration, and have been demonstrated to be valid and reliable indicators of the status and quality of sexual functioning in both men and women. The constructs that form the framework of our diagnostic system for sexual dysfunctions are not amenable to direct physical measurement, so that currently they must be assessed via these self-report scales. Although not as precise as physical measures, these inventories do an admirable job of quantifying and registering sexual functioning status in a concise and reliable manner, and have become indispensable tools in our clinical and research programs.

The field of research in sexual medicine has grown dramatically in the past decade to a point where we now have a substantial armamentarium of pharmacologic and psychological interventions available for the treatment of sexual dysfunctions in men. Concomitantly, numerous new compounds are in advanced stages of clinical development to expand the spectrum of treatment options for women's sexual dysfunctions as well. We believe we have reached a point in our overall research agenda where it may be useful to reappraise certain aspects of our clinical research methodology. We have performed this with a view toward identifying a number of key issues that we believe represent continuing impediments to sustained growth in sexual medicine research, and we have made recommendations concerning implementing tactics and strategies that we believe will help overcome these methodological barriers to continued progress. We do not view the suggestions made here as definitive resolutions to the problems identified, but rather as progressive ideas that will enable our research to continue to move forward.

Introduction: There are limited data concerning the sexual function of women whose male partners receive pharmacological treatment for erectile dysfunction (ED)., Aim: One objective of this research was to prospectively compare the efficacy of vardenafil vs. placebo administered to men with ED in improving men's and women partners' sexual function and satisfaction. Another goal was to assess the relationship of erectile function changes in men with ED receiving treatment with sexual function changes in women partners not directly receiving treatment., Methods: A randomized, double-blind, placebo-controlled, multi-institutional comparison of vardenafil vs. placebo was performed in 229 couples (treated man with ED>6 months and untreated woman partner). Co-primary outcomes for which this research was statistically powered were Sexual Encounter Profile (SEP3) (treated man with ED) and Sexual Life Quality Questionnaire (mSLQQ-QOL) (untreated woman partner)., Main Outcome Measures: Erectile function changes in men with ED receiving vardenafil vs. placebo were compared at last observation carried forward (LOCF) in SEP3, International Index of Erectile Function (IIEF-EF) and Erection Quality Scale (EQS). Sexual function at LOCF in women partners was determined by mSLQQ-QOL and Female Sexual Function Index (FSFI)., Results: Compared with placebo at LOCF, vardenafil significantly increased least square (LS) mean scores in: (i) overall per-treated male SEP3 success rate, IIEF-EF, and EQS; and (ii) mSLQQ-QOL, total FSFI and sexual desire, subjective arousal, lubrication, orgasm and satisfaction FSFI domains in untreated women partners. Treatment-related improvement in erectile function as assessed by IIEF-EF and EQS was correlated reliably with improvement in women partners' FSFI total and individual domain scores., Conclusions: Vardenafil is an effective ED treatment in men that also significantly improves sexual function/satisfaction in untreated women partners. Women partners' sexual function improvements relate significantly and consistently to treatment-related improvements in men's erectile function. ED management should emphasize both members of the couple.

Introduction: The assessment and diagnosis of female sexual dysfunction (FSD) are in a state of transition because of evolving concepts of female sexuality and suggested changes to the FSD diagnostic framework., Aim: To review the problems with current FSD diagnosis., Methods: Multidisciplinary experts from five countries were assembled to convene a "Postmenopausal FSD Roundtable on specific topics related to FSD.", Main Outcome Measure: Expert opinion was based on a review of evidence-based medical literature, presentation, and internal discussion., Results: Current FSD diagnosis is challenging because of poorly defined distinctions between normal and abnormal, a limited ability to integrate subjective and objective findings and an inability to incorporate contextual factors that play a significant role in sexual behavior. The availability of self-administered questionnaires (SAQs) that assess various domains of female sexual function, as well as those developed specifically for postmenopausal women, suggests that a more structured approach to assessment and diagnosis may be possible. Several SAQs reflecting proposed changes to the FSD diagnostic framework by the American Foundation for Urologic Disease (AFUD), including the Sexual Function Questionnaire (SFQ) and the Female Sexual Distress Scale (FSDS), have been introduced and recently incorporated into a Structured Diagnostic Method (SDM). Recent regulatory decisions and events affecting the development of FSD interventions have highlighted the lack of consensus with regard to clinically meaningful FSD outcomes, as well as shortcomings in a U.S. Food and Drug Administration draft document that provides the primary guidance for conducting FSD clinical studies in the United States., Conclusions: Given the high cost and inherent risk of clinical studies, continued development efforts toward FSD therapies are unlikely to proceed in the absence of significant changes in regulatory guidance that reflect the current understanding of FSD and incorporate validated assessment tools.