J Sex Med. 2010 Jul 7;
Abdel-Hamid IA

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Drugs. 2010 Jul 30; 70(11): 1433-43
Hoy SM, Scott LJ

Dapoxetine, a selective serotonin reuptake inhibitor, is the first oral pharmacological agent indicated for the treatment of men aged 18-64 years with premature ejaculation. In four randomized, double-blind, placebo-controlled, multicentre studies of 12-24 weeks’ duration, oral dapoxetine 30 or 60 mg (administered as needed) was effective in the treatment of men with premature ejaculation, inducing significantly (p < 0.001) greater improvements from baseline than placebo in the primary efficacy endpoint (mean intravaginal ejaculatory latency time [IELT] or mean average IELT [defined as the average of IELT values over the previous 4 weeks], as measured by the female partner utilizing a stopwatch). For the most part, dapoxetine recipients achieved significantly better outcomes than placebo recipients with regard to the secondary endpoints, including the Premature Ejaculation Profile (PEP) domains and the Clinical Global Impression or Patient Global Impression ratings of change in premature ejaculation, across these clinical studies. The beneficial effects of dapoxetine therapy on the perceived control over ejaculation and satisfaction with sexual intercourse PEP domains were sustained in a 9-month noncomparative extension phase of two identical 12-week, double-blind studies. Oral dapoxetine therapy for up to 12 months was generally well tolerated in men with premature ejaculation, with the nature of treatment-emergent adverse events generally similar across the clinical studies and between dapoxetine and placebo.

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J Sex Med. 2010 Jun 25;
Carson C, Wyllie M

ABSTRACT Introduction. PSD502 is a novel aerosolized, lidocaine-prilocaine, spray being developed for the treatment of lifelong premature ejaculation. The clinical profile of PSD502 is described in one of two double-blind, placebo-controlled, phase III studies. Aim. To determine the effect of PSD502 on the Index of Premature Ejaculation (IPE) and intravaginal ejaculatory latency (IELT) of men with lifelong PE. Methods. Men with lifelong PE who documented an IELT </= 1 minute with two or more of the first three sexual encounters during a 4-week baseline period were randomized to receive double-blind treatment with PSD502 or placebo for 3 months. Patients completed IPE and Premature Ejaculation Profile questionnaires at entry and monthly visits, and recorded stop-watch timed IELT during each encounter. Safety was assessed by collecting adverse event data and standard safety measures. Main Outcome Measures. Stopwatch timed IELT recordings and a patient-reported outcome questionnaire the IPE were used in this study to determine the effect of PSD502 applied topically 5 minutes before intercourse. Results. Two hundred fifty-six men with PE were randomized from 38 centers in the U.S., Canada, and Poland. The geometric mean IELT over the 3-month treatment period increased from a baseline of 0.56 minute and 0.53 minute in the PSD502 and placebo group respectively to 2.60 and 0.80 minute. There were significantly greater increases in the scores for the IPE domains of ejaculatory control, sexual satisfaction and distress in the PSD502 group than in the placebo group, with a mean 5.0 point difference between treatments in change from baseline in the IPE domain for ejaculatory control, 4.6 point difference in change from baseline in the IPE domain for sexual satisfaction, and a 2.5 point difference in change from baseline in the IPE domain for distress. This was supported by improvements in all secondary endpoints. Conclusion. In this study, PSD502 applied topically to the glans penis 5 minutes before intercourse showed significantly improved ejaculatory latency, ejaculatory control, sexual satisfaction and distress and was shown to be well tolerated by patients and partners. Carson C, and Wyllie M. Improved ejaculatory latency, control and sexual satisfaction when PSD502 is applied topically in men with premature ejaculation: Results of a phase III, double-blind, placebo-controlled study. J Sex Med **;**:**-**.

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J Sex Marital Ther. 2010 Jul; 36(4): 303-12
Jern P, Santtila P, Johansson A, Alanko K, Salo B, Sandnabba NK

Potential effects of sexual orientation on ejaculatory function have been overlooked in the literature. In anticipation of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), attempts have been made to formulate universally suitable definitions for different subtypes of premature ejaculation. However, the proposed definitions are centered around intravaginal ejaculation latency time, and little consideration has been given to whether such definitions are applicable to gay or bisexual men. The present study aimed to investigate effects of sexual orientation on premature and delayed ejaculation. When differences in frequencies and patterns of sexual activities were controlled for, there remained no significant effects of sexual orientation on ejaculatory dysfunction.

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BJU Int. 2010 Jun 14;
Wyllie MG, Hellstrom WJ

Study Type – Aetiology (case control) Level of Evidence 3b OBJECTIVES To investigate the correlation between penile hypersensitivity and premature ejaculation (PE), as defined by the criteria identified by the International Society of Sexual Medicine (ISSM). Penile hypersensitivity as a cause of PE is based on historical clinical neurophysiological data and clinical efficacy of the topical desensitizing agent PSD502 in the treatment of PE. PSD502 is a eutectic-like mixture of two local anaesthetics, lidocaine and prilocaine, whose primary action is to reduce neuronal conduction in sensory afferents. METHODS Historical neurophysiological data was reviewed, together with data from the recent PSD502 clinical trials, including the first published double-blind clinical trial data evaluating a topical desensitizing agent in a population of men with PE, as per the new ISSM definition. The clinical profile of PSD502, based on its local anaesthetic properties, is used as a surrogate index of the role of sensory afferents in the ejaculatory reflex. RESULTS The published data does not support unequivocally penile hypersensitivity as the cause of PE. Interpretation of the data is hampered by the variability of the populations described as having PE across studies. Data from the PSD502 clinical trials clearly shows that PSD502 increases ejaculatory latency, and improves control and sexual satisfaction when applied topically to men with PE 5 min before intercourse, enabling subjects to delay ejaculation up to six times longer than those who used a placebo. CONCLUSION The clinical profile of PSD502 lends credibility to the penile hypersensitivity hypothesis for PE. The predominant action of local anaesthetics is to reduce neuronal firing in sensory afferents; the clinical profile of PSD502, which shows improvement of ejaculatory function in the absence of a generalized reduction in penile sensitivity, can most readily be explained based on an underlying hypersensitivity in patients with PE.

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BJU Int. 2010 Jun 14;
Wyllie MG, Hellstrom WJ

Study Type – Aetiology (case control) Level of Evidence 3b OBJECTIVES To investigate the correlation between penile hypersensitivity and premature ejaculation (PE), as defined by the criteria identified by the International Society of Sexual Medicine (ISSM). Penile hypersensitivity as a cause of PE is based on historical clinical neurophysiological data and clinical efficacy of the topical desensitizing agent PSD502 in the treatment of PE. PSD502 is a eutectic-like mixture of two local anaesthetics, lidocaine and prilocaine, whose primary action is to reduce neuronal conduction in sensory afferents. METHODS Historical neurophysiological data was reviewed, together with data from the recent PSD502 clinical trials, including the first published double-blind clinical trial data evaluating a topical desensitizing agent in a population of men with PE, as per the new ISSM definition. The clinical profile of PSD502, based on its local anaesthetic properties, is used as a surrogate index of the role of sensory afferents in the ejaculatory reflex. RESULTS The published data does not support unequivocally penile hypersensitivity as the cause of PE. Interpretation of the data is hampered by the variability of the populations described as having PE across studies. Data from the PSD502 clinical trials clearly shows that PSD502 increases ejaculatory latency, and improves control and sexual satisfaction when applied topically to men with PE 5 min before intercourse, enabling subjects to delay ejaculation up to six times longer than those who used a placebo. CONCLUSION The clinical profile of PSD502 lends credibility to the penile hypersensitivity hypothesis for PE. The predominant action of local anaesthetics is to reduce neuronal firing in sensory afferents; the clinical profile of PSD502, which shows improvement of ejaculatory function in the absence of a generalized reduction in penile sensitivity, can most readily be explained based on an underlying hypersensitivity in patients with PE.

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Expert Opin Pharmacother. 2010 Jul; 11(10): 1741-52
McMahon CG

Importance of the field: Premature ejaculation (PE) is a common male sexual disorder which is associated with substantial personal and interpersonal negative psychological factors. Drug treatment of PE with an off-label antidepressant selective serotonin reuptake inhibitor (SSRI) drug is common. The lack of an approved drug and total reliance on off-label treatment represents a substantial unmet treatment need. Areas covered in this review: Medline and the proceedings of major international and regional scientific meetings during the period 1994 – 2010 were searched for publications or abstracts using the word ‘dapoxetine’ in the title, abstract or keywords. This search was then manually cross-referenced for all papers. This review encompasses studies of dapoxetine pharmacokinetics, animal studies, human phase I, II and III efficacy and safety studies and drug-interaction studies. Dapoxetine is a potent SSRI, which is administered on demand 1 – 3 h before planned sexual contact. Dapoxetine is rapidly absorbed and eliminated, resulting in minimal accumulation and has dose-proportional pharmacokinetics, which are unaffected by multiple dosing. Dapoxetine 30 and 60 mg has been evaluated in five randomized, double-blind, placebo-controlled studies in 6,081 men aged >/= 18 years. Outcome measures included stopwatch-measured intravaginal ejaculatory latency time (IELT), Premature Ejaculation Profile (PEP) items, clinical global impression of change (CGIC) in PE, and adverse events. Mean IELT, all PEP items and CGIC improved significantly with both doses of dapoxetine versus placebo (p < 0.001 for all). The most common adverse events included nausea, dizziness and headache, and evaluation of validated rated scales demonstrated no SSRI class-related effects with dapoxetine use. What the reader will gain: Readers will gain insight into the epidemiology, pathophysiology and contemporary drug treatment of premature ejaculation. Take home message: Dapoxetine, as the first drug developed for PE, is an effective and safe treatment for PE and represents a major advance in sexual medicine.

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Scand J Public Health. 2010 May 21;
Træen B, Stigum H

AIM: The aim of this study was to describe and analyse the prevalence of sexual problems in Norway. METHODS: The results are based on two samples from 2008, one of which was taken from 1671 web interviews in December among persons ranging from 18-67 years of age, and the other being a survey on sexual behaviour among a random sample of 12,000 Norwegians between the ages of 18 and 59, taken in April. Main outcome measures: The prevalence of sexual problems during the past 12 months. RESULTS: Generalised linear model analyses showed that the highest expected prevalence of manifest problems was found in the following groups: reduced sexual desire problems in 60-67-year-old women with university education (52%); orgasm problems in 18-29-year-old women with less than university education (32%); genital pain in 18-29-year-old women with less than university education (19%); premature ejaculation problems in 18-29-year-old men with less than university education (27%); delayed ejaculation problems in men with less than university education (12%); erectile dysfunction in 60-67-year-old men (34%); and lubrication problems in 60-67-year-old women living in southeast Norway (29%). Sexual problems correlated negatively with sexual wellbeing. CONCLUSIONS: This research indicates that sexual problems represent a public health problem.

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Int J Clin Pract. 2010 Feb; 64(3): 360-70
Simonelli C, Tripodi F, Cosmi V, Rossi R, Fabrizi A, Silvaggi C, Di Pomponio I

INTRODUCTION: In Europe, helplines have become a common counselling service for men and women who are seeking advice for sexual problems. Despite this, relatively few peer-reviewed reports on this subject have been published in the last decade. AIM: To investigate the range of sexual concerns reported by users of an Italian helpline and to describe the differences, if any, between male and female callers; to identify the overlap among sexual difficulties and the associations between the variables of the study. METHODS: The study included selected records of the calls received during the 3-year period between 2006 and 2008 (n = 944). Data were analysed using descriptive statistics and bivariate analysis. RESULTS: Users were more often male (62.2%), aged between 26 and 35 years, who had not sought any previous help. The most frequently reported male sexual difficulties were erectile dysfunction (ED) and premature ejaculation, while the majority of female callers reported vaginismus and orgasmic disorder (OD). We found an association between desire disorder (DD) and ED in men (41.7%), and between OD and DD in women (36.8%). CONCLUSIONS: Telephone counselling is an important and effective resource to elicit requests that otherwise might remain hidden; therefore, it can be a useful link between the health-care system and callers. This is true mainly for men. The next step could be to establish a quality management instrument to investigate whether users find the service helpful.

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Urol Int. 2010 May 6;
Luo S, Lu Y, Wang F, Xie Z, Huang X, Dong Q, Zhang S

Introduction: Lifelong premature ejaculation (LPE) is characterized by persistently shorter intravaginal ejaculation latency time (IELT) than found acceptable by the patient or his partner. It has been postulated to be a neurobiological dysfunction with genetic vulnerability and is related to disturbances of central serotonin (5-hydroxytryptamine, 5-HT) neurotransmission and 5-HT receptor function. Aim: To investigate the relationship between the C-759T and G-697C polymorphisms of the 5-HT(2C) receptor and LPE. Methods: A prospective study was conducted in 106 Han Chinese men with LPE, characterized by IELT of less than 1 min, and 84 healthy controls with IELT of more than 3 min. All subjects were genotyped for the C-759T and G-697C polymorphisms located in the promoter region of the 5-HT(2C) receptor. The frequencies of genotypes and single nucleotide mutations were compared between the two groups. Results: Three genotypes were detected both in the men with LPE and in the control group: -759C/-697G, -759T/-697C, and -759C/ -697C. Genotype -759T/-697G was not detected. The frequency of genotype -759T/-697C was higher in patients with LPE than in the control group (30.2 vs. 11.9%, p < 0.05), whereas the frequency of genotype -759C/-697G was lower in patients with LPE than in the control group (66.0 vs. 83.3%, p < 0.05). No difference was found for genotype -759C/ -697C between the two groups. Mutations at -759T and -697C were more frequent in patients than in the control group (-759T: 30.2 vs. 13.3%, p < 0.05; -697C: 30.4 vs. 16.7%, p < 0.05, respectively). Conclusions: Our findings indicated that polymorphisms in the 5-HT(2C) receptor gene are associated with LPE, and men who carry the -759T or -697C genotype have increased odds of premature ejaculation. Further investigation in this field is necessary.

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