scholarly journals Regulatory perspective on clinical trials and end points for female sexual dysfunction, in particular, hypoactive sexual desire disorder: formulating recommendations in an environment of evolving clinical science

2006 ◽  
Vol 19 (1) ◽  
pp. 30-36 ◽  
Author(s):  
D Shames ◽  
S E Monroe ◽  
D Davis ◽  
L Soule
Keyword(s):  
Clinical Trials ◽  
Sexual Dysfunction ◽  
Sexual Desire ◽  
Female Sexual Dysfunction ◽  
Clinical Science ◽  
Hypoactive Sexual Desire Disorder ◽  
End Points ◽  
Regulatory Perspective ◽  
Desire Disorder

Sexual Dysfunction: Hypoactive Sexual Desire Disorder

2018 ◽  
Author(s):  
John E Buster
Keyword(s):  
Side Effects ◽  
Sexual Dysfunction ◽  
Sexual Desire ◽  
Family Relationships ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Life Quality ◽  
Premenopausal Women ◽  
Reproductive Hormones ◽  
Hypoactive Sexual Desire Disorder ◽  
Desire Disorder

Healthy female sexual functioning is driven by sexual desire. Sexual desire, traditionally defined as sexual thoughts and fantasies, is a natural life force and an art form affecting all aspects of a woman’s interpersonal and professional life. Virtually, all diagnostic categories of female sexual dysfunction, including arousal disorder, anorgasmia, and sexual pain disorder are linked to, caused by, or aggravated by loss of sexual desire. Decreased sexual desire is a diagnosis (hypoactive sexual desire disorder, HSDD) with its own International Classification of Diseases code (F52.0).. Impact is often subtle. HSDD may express as seemingly unrelated emotional disturbances that degrade life quality in family relationships, in the workplace, or both. For some women, it is severely distracting. The diagnosis of HSDD is made when symptoms are sufficient to cause distress. In older women, HSDD is heavily impacted by menopause-associated withdrawal of reproductive hormones, particularly testosterone and estradiol. HSDD greatly improves with transdermal replacement of these steroids. Side effects of transdermal hormones are minimal but response can be gratifying. In premenopausal women, HSDD behaves more as a psychoendocrine disorder that is responsive in some patients to flibanserin, a nonhormonal 5-HT1A receptor agonist. Side effects of flibanserin are significant but manageable. This review contains 12 figures, 6 tables, and  references. Key Words: estradiol, flibanserin, hypoactive sexual desire disorder, menopause, selective serotonin reuptake inhibitors, sexual desire, sexuality, testosterone, transdermal, women

scholarly journals Testosterone Patch Increases Sexual Activity and Desire in Surgically Menopausal Women with Hypoactive Sexual Desire Disorder

2005 ◽  
Vol 90 (9) ◽  
pp. 5226-5233 ◽  
Author(s):  
James Simon ◽  
Glenn Braunstein ◽  
Lila Nachtigall ◽  
Wulf Utian ◽  
Molly Katz ◽  
...  
Keyword(s):  
Placebo Group ◽  
Sexual Activity ◽  
Sexual Desire ◽  
Estrogen Therapy ◽  
Hypoactive Sexual Desire Disorder ◽  
Double Blind ◽  
End Points ◽  
Parallel Group ◽  
Menopausal Women ◽  
Desire Disorder

Abstract Context: Hypoactive sexual desire disorder (HSDD) is one of the most common sexual problems reported by women, but few studies have been conducted to evaluate treatments for this condition. Objective: The objective of this study was to evaluate the efficacy and safety of a testosterone patch in surgically menopausal women with HSDD. Design: The design was a randomized, double-blind, parallel-group, placebo-controlled, 24-wk study (the Intimate SM 1 study). Setting: The study was performed at private or institutional practices. Patients: The subjects studied were women, aged 26–70 yr, with HSDD after bilateral salpingo-oophorectomy who were receiving concomitant estrogen therapy. Placebo (n = 279) or testosterone 300 μg/d (n = 283) was administered. There were 19 patients who withdrew due to adverse events in the placebo group and 24 in the 300 μg/d testosterone group. Intervention: Testosterone (300 μg/d) or placebo patches were applied twice weekly. Main Outcome Measure(s): The primary end point was the change in the frequency of total satisfying sexual activity at 24 wk. Secondary end points included other sexual functioning end points and safety assessments. Results: At 24 wk, there was an increase from baseline in the frequency of total satisfying sexual activity of 2.10 episodes/4 wk in the testosterone group, which was significantly greater than the change of 0.98 episodes/4 wk in the placebo group (P = 0.0003). The testosterone group also experienced statistically significant improvements in sexual desire and a decrease in distress. The overall safety profile was similar in both treatment groups. Conclusion: In the Intimate SM 1 study, the testosterone patch improved sexual function and decreased distress in surgically menopausal women with HSDD and was well tolerated in this trial.

scholarly journals Female Sexual Dysfunction in Patients Treated with Antidepressants: A Comparison between Agomelatine and Escitalopram

2021 ◽  
pp. 196-204
Author(s):  
Virinder Kaur ◽  
Ng Chong Guan ◽  
Jesjeet Singh Gill ◽  
Low Sue-Yin
Keyword(s):  
Sexual Dysfunction ◽  
Sexual Desire ◽  
Female Sexual Dysfunction ◽  
Rating Scale ◽  
Psychiatric Clinic ◽  
Depression Severity ◽  
Cross Sectional ◽  
Care Clinic ◽  
Significant Difference ◽  
Desire Disorder

Aim: This study aims to determine and compare the prevalence of Female Sexual Dysfunction (FSD) between patients on escitalopram and agomelatine, as well as to investigate possible factors associated with their usage. Study Design: Cross-sectional. Place and Duration of Study: Psychiatric Day Care Clinic, Department of Psychological Medicine, University Malaya Medical Centre (UMMC), Malaysia, between November 1, 2020 until February 1, 2021. Methodology: This study is a cross-sectional study involving 66 women with depression from the outpatient psychiatric clinic of a university hospital; 35 of whom were prescribed with escitalopram and 31 with agomelatine. The subjects were in remission and had no significant signs or symptoms of depression for at least 2 months. The prevalence of FSD between the two groups were compared after adjusting for underlying depression severity. Results: This study showed that the overall prevalence rate of FSD was 33.3%, with the prevalence being higher for those on escitalopram (42.9%) than those on agomelatine (22.6%), but did not achieve statistical significance (P=0.081). Out of the six domains of FSD, multivariate analyses revealed that there was a significant reduction of 69% in sexual desire disorder (95% CI:0.110, 0.855), P=0.022 for those on agomelatine compared to escitalopram. Controlling for drug dosage and depression severity (as measured using Montgomery-Asberg Depression Rating Scale), the odds for patients on agomelatine developing sexual desire disorder was 0.267 (95% CI:0.091, 0.783), P=0.016. Conclusion: There was no significant difference in FSD risk between patients on agomelatine and those on escitalopram. Patients on agomelatine were however less likely to develop sexual desire disorder, which demonstrates a slightly better sexual acceptability profile of agomelatine in women in this respect compared to escitalopram.

Pharmacotherapy of male sexual dysfunction: From serendipidity to rational approach to treatment

2011 ◽  
Vol 26 (S2) ◽  
pp. 2035-2035
Author(s):  
R. Balon
Keyword(s):  
Erectile Dysfunction ◽  
Sexual Dysfunction ◽  
Sexual Desire ◽  
Rational Approach ◽  
Sexual Dysfunctions ◽  
Hypoactive Sexual Desire Disorder ◽  
Therapeutic Modalities ◽  
Male Sexual Dysfunction ◽  
Level I ◽  
Desire Disorder

Pharmacotherapy of male sexual dysfunction(s) has developed similar to pharmacotherapy of depression. Some of the treatments for male sexual dysfunctions have been used based on old observations or myths (e.g., so called aphrodisiacs), some based on intuition (e.g. hormones for hypoactive sexual desire disorder), and some were discovered serendipitously (e.g., PDE-5 inhibitors). New, “me-too” PDE-5 inhibitors (e.g., avanafil, mirodenafil, udenafil) are being developed, similar to the development of new antidepressants. A rational approach to pharmacotherapy of hypoactive sexual desire disorder, male erectile disorder and premature ejaculation is being conceptualized (no pharmacotherapy for delayed orgasm is available at present). For instance, the approach to treatment of erectile dysfunction has been frequently staged into three levels (Level I: psychotherapy, oral preparations including hormones, vacuum erectile devices; Level II: intraurethral and intracorporeal application of various preparations; Level III: microsurgery, prosthesis). The management of pharmacotherapy failures, as well as combination of approaches to sexual dysfunctions, (e.g., PDE-5 and hormones for erectile dysfunction) have not been systematically studied. This presentation discusses a rational approach to staging pharmacotherapy of male sexual dysfunction and will also discuss potential combination of therapeutic modalities, especially for treatment resistant cases.

scholarly journals Reliability and validity of the elements of desire questionnaire in premenopausal women with hypoactive sexual desire disorder

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Dennis A. Revicki ◽  
Stanley E. Althof ◽  
Leonard R. Derogatis ◽  
Sheryl A. Kingsberg ◽  
Hilary Wilson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Sexual Desire ◽  
Reliability And Validity ◽  
Premenopausal Women ◽  
Measurement Properties ◽  
Hypoactive Sexual Desire Disorder ◽  
Good Reliability ◽  
Link Type ◽  
Patient Reported ◽  
Desire Disorder

Abstract 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).

scholarly journals Sexual desire disorder in men

2019 ◽  
pp. 33-35
Keyword(s):  
Sexual Dysfunction ◽  
Sexual Function ◽  
Sexual Desire ◽  
Sexual Functioning ◽  
Sexual Life ◽  
Sexual Disorders ◽  
Hypoactive Sexual Desire Disorder ◽  
Multiple Factors ◽  
Sexual Dissatisfaction ◽  
Desire Disorder

Hypoactive sexual desire disorder in men may occur in the context of poor sexual functioning, secondary to sexual dysfunction or a state of sexual dissatisfaction, or may may correspond to poor functioning of the couple. Thus, these multiple factors can generate a hypoactive sexual desire issue. The disorder of desire may also mean cognitions and / or persistently or recurrently reduced(absent) sexual/ erotic fantasies. Worldwide prevalence of sexual desire disorder in men is occasionally 6% for those 8-24 years old; significantly 41% for those 66-74 years old, and persistently 1,8% for those 16-44 years old. The disorder may emerge from the beginning of the sexual life or begin after a period of relatively normal sexual function. Keywords: hypoactive sexual desire disorder, s-on, therapy, testing, evaluation, sexual disorders.

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