Hypoactive Sexual Desire Disorder In Women Research Articles

Women and men with distressing low sexual desire exhibit sexually dimorphic brain processing

Distressing low sexual desire, termed Hypoactive Sexual Desire Disorder (HSDD), affects approximately 10% of women and 8% of men. In women, the ‘top-down’ theory of HSDD describes hyperactivity in higher-level cognitive brain regions, suppressing lower-level emotional/sexual brain areas. However, it is unknown how this neurofunctional disturbance compares to HSDD in men. To investigate this, we employed task-based functional MRI in 32 women and 32 men with HSDD to measure sexual-brain processing during sexual versus non-sexual videos, as well as psychometric questionnaires to assess sexual desire/arousal. We demonstrate that women had greater activation in higher-level and lower-level brain regions, compared to men. Indeed, women who had greater hypothalamic activation in response to sexual videos, reported higher psychometric scores in the evaluative (r = 0.55, P = 0.001), motivational (r = 0.56, P = 0.003), and physiological (r = 0.57, P = 0.0006) domains of sexual desire and arousal after watching the sexual videos in the scanner. By contrast, no similar correlations were observed in men. Taken together, this is the first direct comparison of the neural correlates of distressing low sexual desire between women and men. The data supports the ‘top-down’ theory of HSDD in women, whereas in men HSDD appears to be associated with different neurofunctional processes.

Preparation and In Vitro and In Vivo Evaluation of a Testosterone Film Forming Gel for the Treatment of Hypoactive Sexual Desire Disorder in Women.

Hypoactive sexual desire disorder (HSDD) is one of the most common sexual complaints in women. Currently, there is an unmet need for a drug treatment for this disorder. The purpose of this study was to develop a testosterone (TS) film forming gel used for women to treat HSDD by measuring the tackiness, peel adhesion force, tensile strength, and elasticity of the formulation. Diethylene glycol monoethyl ether (Transcutol P), an efficient penetration enhancer, was added to the optimized formulation and the transdermal permeation characteristics in vitro were studied using Franz-diffusion cells. The quantitative determination of TS was performed by high-performance liquid chromatography (HPLC). After 24 h, Transcutol P at 3% had the largest cumulative amount of drug and enhancement ratio of TS of 75.14 μg/cm2 and 2.82, respectively. After the screening of film forming polymers and penetration enhancers, the optimal formulation was as follows: glycerol (1%, w/w); 12.5% sodium carboxymethylcellulose (CMC-Na) aqueous solution (0.5%, w/w); 2.5% Carbomer ethanol solution (0.5%, w/w); Transcutol P ethanol solution (3%, w/w) containing 0.5% TS; and 8% Poly vinyl alcohol (PVA) aqueous solution (30%, w/w). The optimized film forming gel had good uniformity and the release of TS in vitro was close to 100% within 24 h. In vivo studies showed the formulations had optimal area under blood drug concentration curve values in the order of 3% Transcutol P > 1% Transcutol P > 5% Transcutol P > control preparation. The formulation with 3% Transcutol P provided the highest permeation effect both in vitro and in vivo. The safety of this formulation was further evaluated with a skin irritation test. It could effectively improve the rabbit skin irritation observed with a marketed transdermal patch Androderm®. The present study provides a promising approach for the development of a novel TS film forming gel for the treatment of HSDD in women.

International Society for the Study of Women's Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women.

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

FDA Decisions on Measures of Hypoactive Sexual Desire Disorder in Women: A History, With Grounds to Consider Clinical Judgment.

In 2000, the FDA began issuing advice about treatments for hypoactive sexual desire disorder (HSDD) in women. How its recommendations have evolved has not been reviewed. Its consistent preference for self-rating by patients over evaluation by an examining clinician has not been addressed. Recount the changes in FDA's proposals about patient-reported outcomes and diagnostics. Compare the value of patient-reported measures and clinical interviews. Historical review is based on draft guidances, publications, meetings, and prescribing information. The FDA has avoided clinician input into diagnosis and evaluation of the severity of HSDD in women. It abandoned its initial (2000) insistence on counts of satisfying sexual events to define efficacy in favor of symptom-related scales to evaluate desire and distress with daily self-ratings. By 2015, the FDA accepted the self-rated Female Sexual Function Index-Desire Domain (FSFI-D) to measure desire and the most relevant item of the Female Sexual Distress Scale-Revised (FSDS-R) to measure distress; retrospection for both is one month. TheFDA rejected the one clinician-rated broad measure of HSDD, the Sexual Interest and Desire Inventory (SIDI-F), although well-validated and treatment-sensitive. Since 2005, the FDA has accepted the Decreased Sexual Desire Screener (DSDS) to diagnose HSDD by non-expert clinicians using self-ratings and exploring them in more depth in a clinical interview. FDA's decisions on how to measure HSDD in women may have stabilized on accepting 2 co-primary measures: the FSFI-D and the FSDS-R item on bother about low desire, and on accepting the DSDS for diagnosis. FDA's rejection of clinician ratings of severity through interviews in clinical trials seems unsound because interviews can give broader assessments than (brief) self-ratings, although the agency's logic was to avoid diagnostic controversies and help avoid overcommercialization. Semistructured clinical interviews for diagnosis (DSDS) and severity-rating (SIDI-F) are well validated and are recommended for clinical practice. Pyke RE. FDA Decisions on Measures of Hypoactive Sexual Desire Disorder in Women: A History, With Grounds to Consider Clinical Judgment. Sex Med Rev 2021;9:186-193.

PD36-06 TWO-ARM, PROSPECTIVE, OPEN-LABEL, PILOT STUDY OF FLIBANSERIN VERSUS FLIBANSERIN AND SEX THERAPY IN WOMEN WITH HSDD

You have accessJournal of UrologySexual Function/Dysfunction: Female (PD36)1 Apr 2020PD36-06 TWO-ARM, PROSPECTIVE, OPEN-LABEL, PILOT STUDY OF FLIBANSERIN VERSUS FLIBANSERIN AND SEX THERAPY IN WOMEN WITH HSDD Sue Goldstein*, Rose Hartzell-Cushanick, Caroline Cochran, Noel Kim, and Irwin Goldstein Sue Goldstein*Sue Goldstein* More articles by this author , Rose Hartzell-CushanickRose Hartzell-Cushanick More articles by this author , Caroline CochranCaroline Cochran More articles by this author , Noel KimNoel Kim More articles by this author , and Irwin GoldsteinIrwin Goldstein More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000907.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The most common sexual dysfunction in women is Hypoactive Sexual Desire Disorder (HSDD) with both biologic and psychologic components. Flibanserin was the first FDA-approved medication indicated for safe and effective treatment of HSDD in premenopausal women, but it has also been studied in postmenopausal women with results. Psychological and medical assessments are routinely performed in our sexual medicine practice. The aim of this pilot study was to compare the efficacy of flibanserin alone versus flibanserin with concomitant sex therapy in treating pre- and post-menopausal women with HSDD. METHODS: This open-label, prospective, 2-arm study was conducted at a single research center. Subjects (n = 17) with HSDD meeting inclusion and exclusion received flibanserin 100 mg qhs for 8-weeks. After this run-in period, flibanserin responders were randomized 1:1 to receive study medication alone (n = 5) versus study medication and nine sex therapy sessions (n = 4) over an additional 12 weeks. Responders were defined by a score of 1- 3 on the Patient Global Impression of Improvement (PGI-I). Validated outcome measures, including the Female Sexual Function Index (FSFI) and Female Sexual Distress Score (FSD-DAO) were completed at baseline, 8 weeks and end of study (12 weeks after randomization). Changes in FSFI from the flibanserin responder group at 8 weeks to the end of study (20 weeks) were compared with changes in the flibanserin responder and sex therapy group from the same time period. RESULTS: All subjects showed improvement of HSDD as only responders were randomized. Subjects receiving sex therapy had relationship issues that traditionally respond to sex therapy. FSFI total scores were significantly higher for patients who were in the combined flibanserin/sex therapy group compared to flibanserin alone (p = 0.03). FSFI domain scores in sexual desire, arousal, lubrication and orgasm were consistently higher in the combined group than flibanserin alone, although differences were not statistically significant. Distress, satisfaction and pain assessments were similar for both treatment groups. CONCLUSIONS: The addition of sex therapy to flibanserin treatment for HSDD in women who initially had some response to flibanserin significantly increased overall sexual function compared to flibanserin treatment alone. Although more research is needed, these pilot data suggest that use of a multidisciplinary treatment paradigm may result in better treatment outcomes in patients with HSDD. Source of Funding: Funded by an Investigator Initiated Research Grant from Valeant Pharmaceuticals. © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e725-e725 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Sue Goldstein* More articles by this author Rose Hartzell-Cushanick More articles by this author Caroline Cochran More articles by this author Noel Kim More articles by this author Irwin Goldstein More articles by this author Expand All Advertisement PDF downloadLoading ...

PMD11 - Hypoactive Sexual Desire Disorder (HSDD) is not “The Female Erectile Dysfunction (ED)”: Challenges with the Characterization of HSDD in Women

PMD11 - Hypoactive Sexual Desire Disorder (HSDD) is not “The Female Erectile Dysfunction (ED)”: Challenges with the Characterization of HSDD in Women

Efficacy of Bremelanotide for HSDD in Women: RECONNECT Open-Label Extension Phase Results [8Q

INTRODUCTION: Bremelanotide, an investigational new drug, is a melanocortin 4 receptor agonist that has demonstrated efficacy in treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. The objective of this analysis was to evaluate sustained maintenance of bremelanotide effect on HSDD during the open-label extension (OLE) phase of the RECONNECT Study. METHODS: After completion of the double-blinded, placebo-controlled, core phase of RECONNECT (301 and 302 studies), premenopausal women with HSDD were eligible to enroll in the 52-week OLE. Bremelanotide 1.75 mg was self-administered as desired via auto-injector pen. Efficacy was assessed via FSFI and FSDS-DAO questionnaires. FSFI desire domain (FSFI-D) and FSDS-DAO distress resulting from low desire (Item 13) were co-primary endpoints. Data were collected during clinic visits occurring at 4- to 8-week intervals. OLE baselines for the bremelanotide and placebo groups were core study baseline and end of core study, respectively. RESULTS: For the 301 study OLE, 124 subjects from the bremelanotide arm and 239 subjects from the placebo arm were enrolled. At week 4, subjects who received bremelanotide or placebo in the core phase demonstrated respective mean changes from group baseline of 1.11 and 0.80 in FSFI-D, and -1.20 and -0.60 in FSDS-DAO Item 13. The 302 study had similar OLE results. For all subjects, improvements were consistently maintained until week 52. Similar trends were also observed for multiple secondary endpoints. CONCLUSION: Regardless of core phase treatment, bremelanotide provided treatment benefits in women with HSDD for the duration of the year-long RECONNECT OLE.

Effect Size in Efficacy Trials of Women With Decreased Sexual Desire.

Regarding hypoactive sexual desire disorder (HSDD) in women, some reviewers judge the effect size small for medications vs placebo, but substantial for cognitive behavior therapy (CBT) or mindfulness meditation training (MMT) vs wait list. However, we lack comparisons of the effect sizes for the active intervention itself, for the control treatment, and for the differential between the two. For efficacy trials of HSDD in women, compare effect sizes for medications (testosterone/testosterone transdermal system, flibanserin, and bremelanotide) and placebo vs effect sizes for psychotherapy and wait-list control. We conducted a literature search for mean changes and SD on main measures of sexual desire and associated distress in trials of medications, CBT, or MMT. Effect size was used as it measures the magnitude of the intervention without confounding by sample size. Cohen d was used to determine effect sizes. For medications, mean (SD) effect size was 1.0 (0.34); for CBT and MMT, 1.0 (0.36); for placebo, 0.55 (0.16); and for wait list, 0.05 (0.26). Recommendations of psychotherapy over medication for treatment of HSDD are premature and not supported by data on effect sizes. Active participation in treatment conveys considerable non-specific benefits. Caregivers should attend to biological and psychosocial elements, and patient preference, to optimize response. Few clinical trials of psychotherapies were substantial in size or utilized adequate control paradigms. Medications and psychotherapies had similar, large effect sizes. Effect size of placebo was moderate. Effect size of wait-list control was very small, about one quarter that of placebo. Thus, a substantial non-specific therapeutic effect is associated with receiving placebo plus active care and evaluation. The difference in effect size between placebo and wait-list controls distorts the value of the subtraction of effect of the control paradigms to estimate intervention effectiveness. Pyke RE, Clayton AH. Effect Size in Efficacy Trials of Women With Decreased Sexual Desire. Sex Med Rev 2018;6:358-366.

Effect of Melissa officinalis (Lemon balm) on Sexual Dysfunction in Women: A Double- blind, Randomized, Placebo-controlled Study.

Hypoactive sexual desire disorder (HSDD) is the most prevalent female sexual dysfunction (FSD) and its bio-psychosocial multifactorial etiology justifies its multifaceted treatment. In Persian Medicine (PM), the weakness of the main organs (heart, brain and liver) is one of the important causes of lack of sexual desire; hence, their strengthening is a priority during treatment. Melissa officinalis is one of the medicinal plants with tonic characteristics for the main organs in PM and was used for treatment in this study. The aim of the present study was to evaluate the efficacy and safety of M. officinalis in the improvement of HSDD in women. Eighty nine (89) eligible women suffering from decreased sexual desire were randomly assigned to groups. The participants received medication (500 mg of aqueous extract of M. officinalis) or placebo 2 times a day for 4 weeks. Changes in scores of desire, arousal, lubrication, orgasm, satisfaction and pain were evaluated at the end of 4 weeks of treatment using the Female Sexual Function Index (FSFI) questionnaire in the two groups. Forty three participants completed the study. The increase in desire (P < 0.001), arousal (P < 0.001), lubrication (P < 0.005), orgasm (P < 0.001), satisfaction (P < 0.001), pain (P < 0.002) and FSFI total score (P < 0.001) in the M. officinalis group was significantly more than that of the placebo group. The willingness to continue treatment was significantly higher in the M. officinalis as compared to the placebo group (P < 0.001). M. officinalis may be a safe and effective herbal medicine for the improvement of HSDD in women.

Efficacy and Safety of Flibanserin in Women with Hypoactive Sexual Desire Disorder: A Systematic Review and Meta-Analysis.

Flibanserin, is a postsynaptic agonist of serotonin receptor 1A and an antagonist of serotonin receptor 2A, has been shown to increase sexual desire and reduce distress in women with hypoactive sexual desire disorder (HSDD). We carried out a systematic review and meta-analysis to assess the efficacy and safety of the drug in women with HSDD. A literature review was performed to identify all published randomized double-blind, placebo-controlled trials of flibanserin for the treatment of HSDD. The search included the following databases: MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. The reference lists of the retrieved studies were also investigated. Four publications involving a total of 3,414 patients were used in the analysis, including four randomized controlled trials that compared flibanserin with placebo. For the comparison of flibanserin with placebo, primary efficacy endpoints: satisfying sexual events (the standardized mean difference [SMD] = 0.59, 95% confidence interval [CI] = 0.37-0.80, P < 0.00001); sexual desire score (the SMD = 1.91, 95% CI = 0.21 to 3.60, P = 0.03) and Female Sexual Function Index (FSFI) desire domain score (the SMD = 0.32, 95% CI = 0.19-0.46, P < 0.00001) and key secondary efficacy endpoints: FSFI total score, Female Sexual Distress Scale-Revised (FSDS-R) total score, FSDS-R Item 13 score, Patient's Global Impression of Improvement score and Patient Benefit Evaluation indicated that flibanserin was more effective than the placebo. Safety assessments included the proportion of women who experienced an adverse event (odds ratio = 1.54, 95% CI = .34 to 1.76, P < 0.00001), nervous system disorders and fatigue indicated that flibanserin was well tolerated. This meta-analysis indicates that flibanserin to be an effective and safe treatment for HSDD in women.

Sexual Desire and Hypoactive Sexual Desire Disorder in Women. Introduction and Overview. Standard Operating Procedure (SOP Part 1)

Hypoactive sexual desire disorder (HSDD) is defined in Diagnostic and Statistical Manual of Mental Disorders Fourth Edition as persistent or recurrent deficiency (or absence) of sexual fantasies/thoughts, and/or desire for or receptivity to sexual activity, which causes personal distress. As a largely subjective experience, sexual desire may or may not be accompanied by externally observable changes in sexual behavior. Describe the models of understanding HSDD and the contributing factors to provide the basis for a diagnostic interview and guidance for care for healthcare professionals as a standard operating procedure method. Review of the literature. There are several models which have been developed to describe sexual desire, although there is still no universally accepted definition or description of it. The models are generally divided into more general two-factor models (e.g., excitation-inhibition, appetitive-consummatory) or more specific multifactorial models (in which the different components of sexual activity and their interaction are delineated). The etiology of the disorder is generally considered as multifactorial. Biomedical factors like diseases, drugs, and hormones, and psychological factors like life events, sexual biography, affective state, etc., as well as interpersonal factors like partner satisfaction, communication, duration of the relationship, and sociocultural factors interact with each other and contribute to the individual experience of desire or lack or absence of desire. In analogy to the multifactorial pathogenesis the therapeutic approach is usually multidimensional and includes basic counseling, individual and couple psychotherapy, hormonal and psychopharmacological treatment. The standard operation procedure for HSDD in women must be based on a biopsychosocial, multidimensional, and integrative perspective.

Actualización sobre el trastorno del deseo sexual hipoactivo femenino

Hypoactive sexual desire disorder (HSDD) is the most common type of female sexual dysfunction (FSD). A diagnosis of HSDD requires evidence of personal distress or interpersonal difficulty associated with low sexual desire that cannot be better accounted for by another psychiatric condition and is not due exclusively to a medical condition or substance. HSDD can have a major impact on women's emotional wellbeing and relationships and occurs in both pre- and post-menopausal women. Until recently, diagnosis of HSDD required an extensive diagnostic interview conducted by a clinician with experience in the diagnosis of FSD. The decreased sexual desire screener (DSDS) is a brief diagnostic instrument that has been developed to aid clinicians who are not experts in FSD to diagnose generalized acquired HSDD in women. There is a need for greater understanding of the etiology of HSDD and for more therapeutic options.

Flibanserin and 8‐OH‐DPAT Implicate Serotonin in Association between Female Marmoset Monkey Sexual Behavior and Changes in Pair‐Bond Quality

Psychopathological origins of personally distressing, hypoactive sexual desire disorder (HSDD) in women are unknown, but are generally attributed to an inhibitory neural regulator, serotonin (5-HT). Flibanserin, a 5-HT(1A) agonist and 5-HT(2A) antagonist, shows promise as a treatment for HSDD. To test the hypothesis that female marmoset sexual behavior is enhanced by flibanserin and diminished by 8-OH-DPAT, in order to evaluate the efficacy of serotonergic modulation of female sexual behavior in a pairmate social setting comparable to humans. Sexual and social behavior were examined in eight female marmoset monkeys receiving daily flibanserin (15 mg/kg), 8-OH-DPAT (0.1 mg/kg), or corresponding vehicle for 15-16 weeks in a counterbalanced, within-subject design, while housed in long-term, stable male-female pairs. Marmoset pairmate interactions, including sexual and social behavior, were scored during weeks 5-6 of daily flibanserin, 8-OH-DPAT or vehicle treatment. 24-hour pharmacokinetic profiles of the drugs and their metabolites, as well as drug-induced acute symptoms of the 5-HT behavioral syndrome were also assessed. Two-way analysis of variance reveals that flibanserin-treated females attract more male sexual interest (P=0.020) and trigger increased grooming (P=0.001) between partners. In contrast, 8-OH-DPAT-treated females show increased rejection of male sexual advances (P=0.024), a tendency for decreased male sexual interest (P=0.080), and increased aggression with their male pairmates (P=0.049). While 8-OH-DPAT-treated female marmosets display decreased sexual receptivity and increased aggressive interactions with their male pairmates, flibanserin-treated female marmosets demonstrate increased affiliative behavior with their male pairmates. Such pro-affiliation attributes may underlie flibanserin's effectiveness in treating HSDD in women.

Testosterone Supplementation for Hypoactive Sexual Desire Disorder in Women

Over 50% of women are believed to be affected by female sexual dysfunction (FSD). When particularly distressful, FSD is known as hypoactive sexual desire disorder (HSDD). In contrast to male sexual dysfunction that has been extensively researched, there is less evidence addressing the treatment of HSDD in women, particularly with regard to the use of androgen therapy. A variety of testosterone products, including oral, injectable, and transdermal preparations, has been prescribed for the treatment of HSDD in premenopausal women, as well as in those with naturally occurring or surgically induced menopause. Although studies have shown some benefit with testosterone supplementation in women with HSDD, conflicting evidence and debate regarding the clinical efficacy of testosterone remain. Because of concern over potential adverse events, additional studies with longer follow-up periods are necessary before use of testosterone in women with HSDD becomes widespread. Initiation of testosterone therapy must be considered on an individual basis after a thorough discussion with the patient about risks and benefits.

Gepirone-ER Treatment of Hypoactive Sexual Desire Disorder (HSDD) Associated with Depression in Women

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. To study the effect of gepirone-ER on HSDD in women with major depressive disorder (MDD). 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. Number (%) of patients who no longer met criteria for HSDD (percent resolved). 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). 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.

Reaction to the recent publication by Rosemary Basson entitled ‘Testosterone therapy for reduced libido in women’

Reaction to the recent publication by Rosemary Basson entitled ‘Testosterone therapy for reduced libido in women’

Hypoactive Sexual Desire Disorder and Current Pharmacotherapeutic Options in Women

Hypoactive Sexual Desire Disorder (HSDD) is the most common female sexual dysfunction. The diagnosis of HSDD requires the existence of personal distress or interpersonal difficulties associated with low sexual desire, that cannot be explained by any other psychiatric affection and that is not exclusively due to a disease or substance. HSDD can have a serious effect on emotional wellbeing and interpersonal relationships, and it occurs in premenopausal and postmenopausal women. The Decreased Sexual Desire Screener is a shortened diagnostic method designed to help doctors who are not specialized in female sexual dysfunction to diagnose acquired HSDD in women. There is evidence that treatment with androgens or with estrogens is effective in HSDD; however, important unanswered questions still exist. Presently, new therapeutic strategies to combat HSDD are being researched, including novel methods of testosterone provision and drugs that act upon the CNS.

Flibanserin: A Potential Treatment for Hypoactive Sexual Desire Disorder in Premenopausal Women

Hypoactive Sexual Desire Disorder (HSDD) is defined as a persistent or recurrent deficiency of sexual fantasies and desire for sexual activity, which causes marked personal distress or interpersonal difficulty, and is not better accounted for by another psychiatric disorder or the direct physiological effects of a substance (e.g., a medication) or medical condition. HSDD is believed to be the most common form of Female Sexual Dysfunction and is associated with emotional distress and relationship problems. No pharmacologic therapy is approved for the treatment of HSDD in premenopausal or naturally postmenopausal women. Flibanserin is a 5-HT(1A) agonist/5-HT(2A) antagonist that is under investigation as a treatment for HSDD in women. The aim of this article is to present an overview of the pharmacology, clinical efficacy and safety of flibanserin. Flibanserin is an investigational drug that is not licensed for any indication in any country.

ORIGINAL RESEARCH—EPIDEMIOLOGY: The HSDD Registry for Women: A Novel Patient Registry for Women with Generalized Acquired Hypoactive Sexual Desire Disorder

Hypoactive sexual desire disorder (HSDD) is a clinically challenging disorder in women. Little is known about the natural history of the disorder and long-term consequences. A longitudinal registry can address these needs. To design and implement a registry study of HSDD in women to characterize the natural history of HSDD and current treatment practices. A longitudinal multicenter registry study has been initiated at clinical sites across the United States. A total of 1,500 women (approximately 1,000 premenopausal, 500 postmenopausal) with clinically-diagnosed HSDD, confirmed by the Decreased Sexual Desire Screener, will be recruited over 24 months at up to 40 clinical sites. Participants will be followed with in-clinic or remote, computer-assisted follow-up. Data from the initial implementation phase was analyzed to assess feasibility of the protocol. A qualitative substudy (N = 40) was conducted to assess content validity of the participant questionnaire. The primary outcome measure for the Registry study is a patient-based global impression of change in HSDD. Secondary outcome measures are derived from two sources: (i) self-administered questionnaire completed by the participant, and (ii) medical history review completed by the clinician. The questionnaire includes validated measures of sexual function, quality of life, relationship factors, and physical and mental health, as well as newly developed questions on treatments and medications. As of February 12, 2009, 290 women (209 premenopausal, 81 postmenopausal) had been recruited from 15 clinical sites. Results of the initial implementation phase and qualitative substudy on the participant questionnaire show that the Registry protocol is highly feasible and the questionnaire consisting of previously validated scales and selected new items has high content validity. As the first longitudinal registry study in female sexual dysfunction, the HSDD Registry will contribute to a broader understanding of the impact and treatment needs of women with clinically diagnosed HSDD.

Validation of the Decreased Sexual Desire Screener (DSDS): A Brief Diagnostic Instrument for Generalized Acquired Female Hypoactive Sexual Desire Disorder (HSDD)

An accurate diagnosis of Hypoactive Sexual Desire Disorder (HSDD) currently relies on a time-consuming interview with an expert clinician. Limited access to such expertise means that many women with HSDD remain undiagnosed. The Decreased Sexual Desire Screener (DSDS) was developed to provide clinicians who are neither trained nor specialized in Female Sexual Dysfunction (FSD) with a brief diagnostic procedure for the diagnosis of generalized acquired HSDD in women. A prospective non-treatment multicenter study enrolled 263 women at 27 centers in North America in order to test the validity of the DSDS for diagnosing generalized acquired HSDD in women. Subjects completed the DSDS at the screening visit and their answers were reviewed with a clinician who was not an expert in FSD ("non-expert clinician"). Separately and while being unaware of the non-expert clinician's diagnosis, an expert clinician conducted a standard diagnostic interview. Diagnostic outcomes (generalized acquired HSDD or not) were compared. Primary endpoints included the sensitivity and specificity of the DSDS relative to the standard diagnostic interview. Subject and non-expert clinician debriefing were obtained via a written, structured interview. This ensured that a large sample could be tested under uniform conditions across multiple sites. Diagnostic assessment by DSDS and standard diagnostic interview were in agreement in 85.2% (224/263) of cases, with the sensitivity and specificity of the DSDS 83.6% and 87.8%, respectively. Debriefing showed that the five DSDS questions were well understood by 85.4% (76/89) of subjects included in the debriefing exercise, while non-expert clinicians considered the DSDS questions adequate to diagnose HSDD in 92.9% (235/253) of cases. The DSDS is a sensitive and specific brief diagnostic instrument for generalized acquired HSDD in women that is quick and easy to use.