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Recent Developments in Psychopharmaceutical Approaches to Treating Female Sexual Interest and Arousal Disorder.

ABSTRACT: Purpose of Review:This review summarizes the recent literature and empirical studies on psychopharmacological approaches to treating female sexual interest/arousal disorder (FSIAD). Recent Findings:Several new drugs for FSIAD that are intended to increase sexual responsiveness by influencing central excitatory and inhibitory neuromodulatory processes are under development. Studies on flibanserin resulted in the first approved medication for the treatment of low sexual desire in premenopausal women. New drugs under development are testosterone combined with sildenafil or buspiron, bremelanotide, BP101, and nasal testosterone (TBS-2). Summary:Although pharmacological enhancement of sexual responsiveness may be potentially helpful in the treatment of FSIAD, the observed effects of flibanserin and other new drugs under development seem limited in terms of clinical significance. Given the multifactorial character of FSIAD, it may be important to integrate psychopharmacological treatment with sex therapy for optimal treatment efficacy.

SUBMITTER: Both S

PROVIDER: S-EPMC5711968 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Recent Developments in Psychopharmaceutical Approaches to Treating Female Sexual Interest and Arousal Disorder.

Both Stephanie S

Current sexual health reports 20171019 4

<h4>Purpose of review</h4>This review summarizes the recent literature and empirical studies on psychopharmacological approaches to treating female sexual interest/arousal disorder (FSIAD).<h4>Recent findings</h4>Several new drugs for FSIAD that are intended to increase sexual responsiveness by influencing central excitatory and inhibitory neuromodulatory processes are under development. Studies on flibanserin resulted in the first approved medication for the treatment of low sexual desire in pr ...[more]

PMID: 29225554

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

Project description:BackgroundFor 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.MethodsPsychometric 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).ResultsConfirmatory 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.ConclusionsEvidence 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.

Dataset Information

Recent Developments in Psychopharmaceutical Approaches to Treating Female Sexual Interest and Arousal Disorder.

Publications

Recent Developments in Psychopharmaceutical Approaches to Treating Female Sexual Interest and Arousal Disorder.

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