Dataset Information

Prevalence of Hypoactive Sexual Desire Disorder Among Sexually Active Postmenopausal Women With Metabolic Syndrome at a Public Hospital Clinic in Brazil: A Cross-sectional Study.

ABSTRACT: AIMS:To evaluate the prevalence of hypoactive sexual desire disorder (HSDD) among postmenopausal women diagnosed with metabolic syndrome (MS) and to compare it to that of a control group without MS. METHODS:This is a cross-sectional study carried out in 2 public tertiary hospitals in the state of São Paulo, Brazil, with a sample of 291 postmenopausal women aged between 40 and 65 years. Sexual function was evaluated using the Female Sexual Function Index (FSFI) questionnaire and Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, diagnostic criteria and was related to the diagnosis of MS, which was determined according to the guidelines defined by the Adult Treatment Panel. MAIN OUTCOME MEASURES:Analysis of sexual function with emphasis on sexual desire (HSDD), the incidence of MS, and the components of MS. RESULTS:The prevalence of HSDD was significantly higher among women diagnosed with MS than among women without MS (P = .01). Women diagnosed with high blood pressure (P < .01) and increased triglycerides (P = .03) also had a higher prevalence of HSDD than did women without these conditions. The FSFI domain scores for desire, arousal, lubrication, orgasm, and satisfaction and the total FSFI score were significantly lower for postmenopausal women with MS, whereas the pain domain score was not significantly different between the groups (P = .913). The incidence of female sexual dysfunction was significantly higher among women with MS, regardless of the diagnostic criteria used (P < .05). CONCLUSION:Postmenopausal women diagnosed with MS have higher rates of HSDD than do women without MS. CLINICAL TRIAL REGISTRATION:ID NCT02430987. Dutra da Silva GM, Rolim Rosa Lima SM, Reis BF, et al. Prevalence of Hypoactive Sexual Desire Disorder Among Sexually Active Postmenopausal Women With Metabolic Syndrome at a Public Hospital Clinic in Brazil: A Cross-sectional Study. J Sex Med 2020;8:545-553.

SUBMITTER: Dutra da Silva GM

PROVIDER: S-EPMC7471087 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Prevalence of Hypoactive Sexual Desire Disorder Among Sexually Active Postmenopausal Women With Metabolic Syndrome at a Public Hospital Clinic in Brazil: A Cross-sectional Study.

Dutra da Silva Gustavo Maximiliano GM Rolim Rosa Lima Sônia Maria SM Reis Benedito F BF Macruz Carolina Furtado CF Postigo Sóstenes S

Sexual medicine 20200624 3

<h4>Aims</h4>To evaluate the prevalence of hypoactive sexual desire disorder (HSDD) among postmenopausal women diagnosed with metabolic syndrome (MS) and to compare it to that of a control group without MS.<h4>Methods</h4>This is a cross-sectional study carried out in 2 public tertiary hospitals in the state of São Paulo, Brazil, with a sample of 291 postmenopausal women aged between 40 and 65 years. Sexual function was evaluated using the Female Sexual Function Index (FSFI) questionnaire and Di ...[more]

PMID: 32593675

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Project description:ObjectiveTo evaluate the long-term safety and efficacy of bremelanotide as treatment for hypoactive sexual desire disorder in premenopausal women.MethodsWomen who completed the 24-week double-blind core phase of RECONNECT, composed of two parallel phase 3 trials (301 and 302) examining the safety and efficacy of bremelanotide compared with placebo in premenopausal women with hypoactive sexual desire disorder, could enroll in the 52-week open-label extension, provided they had not experienced serious adverse events during the core phase. Efficacy was assessed using the coprimary endpoints from the core phase, and all adverse events were collected during the open-label extension. All statistical analyses were descriptive.ResultsThe study 301 open-label extension began on July 17, 2015, and concluded on July 13, 2017; the study 302 open-label extension began on October 5, 2015, and concluded on June 29, 2017. Of the 856 eligible patients who completed the core phase, 684 elected to participate in the open-label extension, and 272 completed it. The most common treatment-emergent adverse events considered related to study drug were nausea (40.4%), flushing (20.6%), and headache (12.0%), and the only severe treatment-emergent adverse event experienced by more than one participant in both studies was nausea during the open-label extension. The change in Female Sexual Function Index-desire domain score and Female Sexual Distress Scale-Desire/Arousal/Orgasm item 13 from baseline to end of the open-label extension ranged from 1.25 to 1.30 and -1.4 to -1.7, respectively, for patients who received bremelanotide during the core phase, and 0.70-0.77 and -0.9, respectively, for patients who received placebo during the core phase.ConclusionDuring the 52-week open-label extension of RECONNECT, no new safety signals were observed, and premenopausal women treated with bremelanotide exhibited sustained improvements in hypoactive sexual desire disorder symptoms.Clinical trial registrationClinicalTrials.gov, NCT02333071 (study 301) and NCT02338960 (study 302).Funding sourcePalatin Technologies, Inc., and AMAG Pharmaceuticals, Inc.

Project description:IntroductionCounts of satisfying sexual events (SSEs) per month have been criticized as an end point in treatment trials of women with hypoactive sexual desire disorder (HSDD) but grounding improvement in sexual desire by assessing changes in sexual behavior remains of some importance.MethodsWe conducted a literature review to find validated measurements that are specific sexual behavioral correlates of low sexual desire. We compared expert-proposed criteria for dysfunctional desire, expert-developed sets of scale items, and self-rated scales developed before issuance of, or in accordance with, the Food and Drug Administration's guidance on developing patient-reported outcomes. Behavioral measurements of HSDD were isolated from these sets of criteria or scales.Main outcome measuresWe outline a plan to evaluate such behavioral measurements of HSDD with reference to SSEs.ResultsEleven rating scales, four expert-originated and seven self-rated scales mainly derived from patient input were identified as well validated and relevant to HSDD. Three recent sets of diagnostic criteria for conditions such as HSDD were compared with the scales. Twenty-four different symptoms were found in the scales. Content found relevant to HSDD during development of the rating scales varied highly among measurements, including the self-rated scales developed in conformity with current recommendations for patient-reported outcome measurements. The only item on all sets was desire for sexual activity. Four other items were in approximately at least half the sets: sexual thoughts or fantasies, frequency of sexual activity, receptivity, and initiations. Sexual thoughts or fantasies were in every expert-derived set but in only three of the seven patient-derived sets. Receptivity was in five of the seven expert-derived sets vs two of the seven patient-derived sets. Frequency of sexual activity was in one of the seven expert-derived sets but in five of the patient-derived sets. Initiation was in approximately half the two sets. All other items were on one to three sets each. We identified three sexual behaviors of validated specificity for female HSDD: frequency of sexual activity, receptivity, and initiations. Six or seven items are relevant and informative. The item on frequency of sexual activity in the Changes in Sexual Functioning-Female scale is the only item that covers frequency of dyadic and solitary sexual activity. An item in the Female Sexual Desire Questionnaire (FSDQ) covers the intuitively relevant topic of frequency of sexual activity motivated by the woman's desire. Three FSDQ items on initiations and two items on receptivity reflect expert opinion on the sexual behaviors of most relevance to HSDD, but the FSDQ has not been validated in women with HSDD.ConclusionsSSEs have been discredited as the primary measurement in clinical trials of women with HSDD, but it would be meaningful to include at least one sexual behavioral symptom specific to HSDD as an end point. Expert-recommended sexual behaviors specifically related to HSDD are irregularly represented in self-rating scales whether developed as in the Food and Drug Administration guidance on patient-reported outcomes or not. Six or seven items on sexual behavior in self-rated scales can be recommended for relevance to women with HSDD in clinical trials. Items on female sexual behavior should be tested in comparison with SSEs in women with HSDD for relevance and for treatment sensitivity, and responder and functional and dysfunctional cutoffs should be determined before incorporation into large-scale clinical trials. Pyke R and Clayton A. What Sexual Behaviors Relate to Decreased Sexual Desire in Women? A Review and Proposal for End Points in Treatment Trials for Hypoactive Sexual Desire Disorder. Sex Med 2017;5:e73-e83.

Project description:ObjectiveTo evaluate the safety and efficacy of bremelanotide for the treatment of premenopausal women with hypoactive sexual desire disorder.MethodsTwo identical phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trials (RECONNECT) evaluated the safety and efficacy of bremelanotide 1.75 mg administered subcutaneously as needed in premenopausal women with hypoactive sexual desire disorder. Patients were randomized 1:1 to 24 weeks of treatment with bremelanotide or placebo. Sample size was estimated based on simulations from key endpoints in patients with hypoactive sexual desire disorder from a prior trial. Coprimary efficacy endpoints were change from baseline to end-of-study in the Female Sexual Function Index-desire domain score and Female Sexual Distress Scale-Desire/Arousal/Orgasm item 13.ResultsStudy 301 began on January 7, 2015, and concluded on July 26, 2016. Study 302 began on January 28, 2015, and concluded on August 4, 2016. Of the 1,267 women randomized, 1,247 and 1,202 were in the safety and efficacy (modified intent-to-treat) populations, respectively. Most participants were white (85.6%), from U.S. sites (96.6%), and had a mean age of 39 years. From baseline to end-of-study, women taking bremelanotide had statistically significant increases in sexual desire (study 301: 0.30, P<.001; study 302: 0.42, P<.001; integrated studies 0.35, P<.001) and statistically significant reductions in distress related to low sexual desire (study 301: -0.37, P<.001; study 302: -0.29, P=.005; integrated studies -0.33, P<.001) compared with placebo. Patients taking bremelanotide experienced more nausea, flushing, and headache (10% or more in both studies) compared with placebo.ConclusionsBoth studies demonstrated that bremelanotide significantly improved sexual desire and related distress in premenopausal women with hypoactive sexual desire disorder. The safety profile was favorable. Most treatment-emergent adverse events were related to tolerability and the majority were mild or moderate in intensity.Clinical trial registrationClinicalTrials.gov, NCT02333071 (study 301) and NCT02338960 (study 302).Funding sourcePalatin Technologies, Inc., and AMAG Pharmaceuticals, Inc.

Project description:The success of global treatment as prevention (TasP) efforts for individuals living with HIV/AIDS (PLWHA) is dependent on successful implementation, and therefore the appropriate contribution of social and behavioral science to these efforts. Understanding the psychosocial context of condomless sex among PLWHA could shed light on effective points of intervention. HPTN 063 was an observational mixed-methods study of sexually active, in-care PLWHA in Thailand, Zambia, and Brazil as a foundation for integrating secondary HIV prevention into HIV treatment. From 2010-2012, 80 qualitative interviews were conducted with PLWHA receiving HIV care and reported recent sexual risk. Thirty men who have sex with women (MSW) and 30 women who have sex with men (WSM) participated in equal numbers across the sites. Thailand and Brazil also enrolled 20 biologically-born men who have sex with men (MSM). Part of the interview focused on the impact of HIV on sexual practices and relationships. Interviews were recorded, transcribed, translated into English and examined using qualitative descriptive analysis. The mean age was 25 (SD = 3.2). There were numerous similarities in experiences and attitudes between MSM, MSW and WSM across the three settings. Participants had a high degree of HIV transmission risk awareness and practiced some protective sexual behaviors such as reduced sexual activity, increased use of condoms, and external ejaculation. Themes related to risk behavior can be categorized according to struggles for intimacy and fears of isolation, including: fear of infecting a sex partner, guilt about sex, sexual communication difficulty, HIV-stigma, and worry about sexual partnerships. Emphasizing sexual health, intimacy and protective practices as components of nonjudgmental sex-positive secondary HIV prevention interventions is recommended. For in-care PLWHA, this approach has the potential to support TasP. The overlap of themes across groups and countries indicates that similar intervention content may be effective for a range of settings.

Dataset Information

Prevalence of Hypoactive Sexual Desire Disorder Among Sexually Active Postmenopausal Women With Metabolic Syndrome at a Public Hospital Clinic in Brazil: A Cross-sectional Study.

Publications

Prevalence of Hypoactive Sexual Desire Disorder Among Sexually Active Postmenopausal Women With Metabolic Syndrome at a Public Hospital Clinic in Brazil: A Cross-sectional Study.

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