title: On-demand use of tramadol, sildenafil, paroxetine and local anaesthetics for the management of premature ejaculation: A randomised placebo-controlled clinical trial Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials The effects of fluoxetine on several neurophysiological variables in patients with premature ejaculation. Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries. Comparison Between Tadalafil Plus Paroxetine and Paroxetine Alone in the Treatment of Premature Ejaculation Effect of SSRI antidepressants on ejaculation: a double-blind, randomized, placebo-controlled study with fluoxetine, fluvoxamine, paroxetine, and sertraline. Treatment of premature ejaculation with paroxetine hydrochloride as needed: 2 single-blind placebo controlled crossover studies. Treatment benefit of dapoxetine for premature ejaculation: results from a placebo‐controlled phase III trial Safety and efficacy of vardenafil versus sertraline in the treatment of premature ejaculation: a randomised, prospective and crossover study Comparison between on-demand dosing of dapoxetine alone and dapoxetine plus mirodenafil in patients with lifelong premature ejaculation: prospective, randomized, double-blind, placebo-controlled, multicenter study. Antidepressants and Ejaculation: A Double-Blind, Randomized, Placebo-Controlled, Fixed-Dose Study With Paroxetine, Sertraline, and Nefazodone Efficacy and safety of dapoxetine in men with premature ejaculation and concomitant erectile dysfunction treated with a phosphodiesterase type 5 inhibitor: randomized, placebo-controlled, phase III study. Comparison of efficacy of sildenafil-only, sildenafil plus topical EMLA cream, and topical EMLA-cream-only in treatment of premature ejaculation. Sertraline in the treatment of premature ejaculation: A double-blind placebo controlled study Combination therapy with selective serotonin reuptake inhibitors and phosphodiesterase‐5 inhibitors in the treatment of premature ejaculation In vitro measurement of ejaculation latency time (ELT) and the effects of vardenafil on ELT on lifelong premature ejaculators: placebo-controlled, double-blind, cross-over laboratory setting Tadalafil and Fluoxetine in Premature Ejaculation: Prospective, Randomized, Double-Blind, Placebo-Controlled Study Effect of Fluoxetine Alone and in Combination with Sildenafil in Patients with Premature Ejaculation Can sildenafil treat primary premature ejaculation? A prospective clinical study. [Comparison between sildenafil plus sertraline and sertraline alone in the treatment of premature ejaculation]. A multinational population survey of intravaginal ejaculation latency time.
abstract: Abstract Objectives : To compare the clinical efficacy of the on-dem and use of four drugs in the management of patients with premature ejaculation ( PE ) , as the off-label use of selective serotonin-reuptake inhibitors and topical penile anaesthetics is frequently indicated for the management of patients with PE , and tramadol HCl and sildenafil citrate were also tried for managing this disorder , but with recommendations based on weak evidence . Patients and methods : This was a single-centre , single-blind , placebo-controlled clinical trial conducted on 150 patients who had PE for > 1 year . Patients were r and omised equally into five groups .  On-dem and tramadol , sildenafil , paroxetine , local lidocaine gel or placebo was given for patients in groups 1–5 , respectively . During the month before treatment , the intravaginal ejaculation latency time ( IELT ) and sexual satisfaction scores ( on a 0–5-point scale ) were measured and compared to the mean IELT and sexual satisfaction scores recorded during 4 weeks of on-dem and drug administration , with monitoring of any possible side-effects . Results : Tramadol-treated patients had a significantly longer mean ( SD ) IELT , of 351 ( 119 ) s , than the other groups . Local anaesthetic was significantly better than paroxetine in prolonging the IELT , at 278 ( 111 ) vs. 186 ( 65 ) s , respectively . The improvement in sexual satisfaction was significantly better in the sildenafil group , with a mean ( SD ) improvement of 2.9 ( 1 ) points , than in the paroxetine and local anaesthetic groups , at 2.2 ( 0.9 ) and 1.9 ( 0.9 ) points , respectively . Conclusions : The four drugs significantly improved IELT values over placebo . Tramadol was associated with significantly longer IELT values , whilst sildenafil induced significantly better sexual satisfaction than the other drugs . The four drugs had tolerable side-effects BACKGROUND No drugs are approved for treatment of premature ejaculation . Our aim was to determine the efficacy and tolerability of on-dem and dapoxetine in patients with severe premature ejaculation . METHODS We determined the efficacy of dapoxetine in a prospect ively predefined integrated analysis of two 12-week r and omised , double-blind , placebo-controlled , phase III trials of identical design done independently , in parallel , at 121 sites in the USA . Men with moderate-to-severe premature ejaculation in stable , heterosexual relationships took placebo  ( n=870 ) , 30 mg dapoxetine ( 874 ) , or 60 mg dapoxetine ( 870 ) on-dem and ( as needed , 1 - 3 h before anticipated sexual activity ) . The primary endpoint was intravaginal ejaculatory latency time ( IELT ) measured by stopwatch . Safety and tolerability were assessed . All analyses were done on an intention-to-treat basis . The trials are registered at Clinical Trials.gov , numbers NCT00211107 and NCT00211094 . FINDINGS 672 , 676 , and 610 patients completed in the placebo , 30 mg dapoxetine , and 60 mg dapoxetine groups , respectively . Dapoxetine significantly prolonged IELT ( p<0.0001 , all doses vs placebo ) . Mean IELT at baseline was 0.90 ( SD 0.47 ) minute , 0.92 ( 0.50 ) minute , and 0.91 ( 0.48 ) minute , and at study endpoint ( week 12 or final visit ) was 1.75 ( 2.21 ) minutes for placebo , 2.78 ( 3.48 ) minutes for 30 mg dapoxetine , and 3.32 ( 3.68 ) minutes for 60 mg dapoxetine . Both dapoxetine doses were effective on the first dose . Common adverse events ( 30 mg and 60 mg dapoxetine , respectively ) were nausea ( 8.7 % , 20.1 % ) , diarrhoea ( 3.9 % , 6.8 % ) , headache ( 5.9 % , 6.8 % ) , and dizziness ( 3.0 % , 6.2 % ) . INTERPRETATION On-dem and dapoxetine is an effective and generally well tolerated treatment for men with moderate-to-severe premature ejaculation PURPOSE Fluoxetine , a selective serotonin re-uptake inhibitor , has been shown to increase the intravaginal latency of patients with premature ejaculation . We demonstrated the effects of fluoxetine on intravaginal latency , penile sensory threshold , and variables of sacral evoked response and cortical somatosensorial evoked potential in patients with premature ejaculation . MATERIAL S AND METHODS Of 48 patients 40 who presented to our clinic with premature ejaculation met the study criteria , gave written or oral consent , and were divided r and omly in a double-blind fashion into 2 groups of 20 patients . The study group received 20 mg . fluoxetine daily and the control group received placebo for 1 month . The patients were evaluated during visits before and after treatment for intravaginal latency , penile sensory threshold values , and the variables of sacral evoked response and cortical somatosensory evoked potential tests . RESULTS Patient ages , intravaginal latencies , penile sensory threshold values , and amplitudes and latencies of sacral evoked response and cortical somatosensory evoked potential tests in both groups were not significantly different at the beginning of treatment ( p > 0.05 ) . At the end of treatment intravaginal latencies and penile sensory threshold values were increased in the study group compared to before treatment and the control group ( p < 0.05 ) . No change was observed in either group for the amplitudes and latencies of sacral evoked response and cortical somatosensory evoked potential tests ( p > 0.05 ) . CONCLUSIONS These findings suggest that fluoxetine is effective treatment for premature ejaculation probably due to its effect of increasing the penile sensory threshold , without changing the amplitudes and latencies of sacral evoked response and cortical somatosensory evoked potential BACKGROUND Dapoxetine is being developed for the on-dem and treatment of premature ejaculation ( PE ) . Previous clinical trials have demonstrated its safety and efficacy . OBJECTIVE To evaluate the long-term efficacy and safety of dapoxetine in men with PE . DESIGN , SETTING , AND PARTICIPANTS This r and omized , double-blind , parallel-group , placebo-controlled , phase 3 trial , conducted in 22 countries , enrolled men ( N=1162 ) > or = 18 yr of age who met the Diagnostic and Statistical Manual of Mental Disorders , fourth edition , text revision criteria for PE for > or = 6 mo , with an intravaginal ejaculatory latency time ( IELT ) < or = 2 min in > or = 75 % of intercourse episodes at baseline . INTERVENTION Dapoxetine 30 mg or dapoxetine 60 mg or placebo on dem and ( 1 - 3 h before intercourse ) for 24 wk . MEASUREMENTS Stopwatch-measured IELT , Premature Ejaculation Profile ( PEP ) , Clinical Global Impression ( CGI ) of change , adverse events ( AEs ) . RESULTS AND LIMITATIONS The study was completed by 618 men .  Mean average IELT increased from 0.9 min at baseline ( all groups ) to 1.9 min , 3.2 min , and 3.5 min with placebo and dapoxetine 30 mg and dapoxetine 60 mg , respectively , at study end point ; geometric mean IELT increased from 0.7 min at baseline to 1.1 min , 1.8 min , and 2.3 min , respectively , at study end point . All PEP measures and IELTs improved significantly with dapoxetine versus placebo at week 12 and week 24 ( p<0.001 for all ) . The most common AEs were nausea , dizziness , diarrhea , and headache . AEs led to discontinuation in 1.3 % , 3.9 % , and 8.2 % of subjects with placebo and dapoxetine 30 mg and dapoxetine 60 mg , respectively . Limitations of this study included the exclusion of men who were not in long-term monogamous relationships . CONCLUSIONS Dapoxetine significantly improved all aspects of PE and was generally well tolerated in this broad population Background : Several recent studies have investigated the therapeutic role of phosphodiesterase type 5 ( PDE5 ) inhibitors in premature ejaculation ( PE ) used in the treatment of erectile dysfunction . Objectives : In the present research , the efficacy of paroxetine alone and paroxetine plus tadalafil was compared in patients referred because of premature ejaculation . Patients and Methods : This quasi-experimental study was performed on 100 consecutive 17 to 49-year-old potent men with premature ejaculation and without any clear organic disease . All patients had lifelong PE with an intravaginal ejaculation latency time ( IELT ) shorter than 1.5 minutes . Informed consent was obtained from all patients who were r and omly divided into two groups using a computer-generated r and om tabulation list . In group A , patients received 10 mg paroxetine daily , in addition to four hours before planned sexual activity . In group B , 10 mg paroxetine was taken daily , plus 10 mg tadalafil one hour before planned sexual activity . The duration of the intervention was six months and patients were evaluated for IELT three and six months after the beginning of therapy . Results : The mean age of patients in groups A and B were 33 ± 9.6 and 31.2 ± 9.3 years , respectively ( P = 0.368 ) . The mean number of intercourses were 1.08 ± 0.6 and 1.12 ± 0.6 per week in groups A and B , respectively ( P = 0.791 ) . Mean IELT at the 3-month follow up in groups A and B was 4.5 ± 1.5 and 5 ± 2.4 minutes , respectively ( P = 0.285 ) and at the 6-month follow up was 4.8 ± 1 and 5.3 ± 2 minutes , respectively ( P = 0.278 ) . Conclusions : The results of the study show that tadalafil can increase the mean IELT and can be used for treatment of premature ejaculation in combination with paroxetine Depression is a common cause of sexual dysfunction , but also antidepressant medication is often associated with sexual side effects . This article includes two related studies . The first double-blind , placebo-controlled study was conducted in men with lifelong rapid ejaculation and aim ed to assess putative differences between the major selective serotonin reuptake inhibitors ( SSRIs ) ( fluoxetine , fluvoxamine , paroxetine , and sertraline ) with regard to their ejaculation-delaying effect .  Sixty men with an intravaginal ejaculation latency time ( IELT ) of 1 minute or less were r and omly assigned to receive fluoxetine 20 mg/day , fluvoxamine 100 mg/day , paroxetine 20 mg/day , sertraline 50 mg/day , or placebo for 6 weeks . During the 1-month baseline and 6-week treatment periods , the men measured their IELT at home using a stopwatch . The trial was completed by 51 men . During the 6-week treatment period , the geometric mean IELT in the placebo group was constant at approximately 20 seconds . Analysis of variance revealed a between-groups difference in the evolution of IELT delay ( p = 0.0004 ) ; in the paroxetine , fluoxetine , and sertraline groups there was a gradual increase to about 110 seconds , whereas in the fluvoxamine group , IELT was increased to only approximately 40 seconds . The paroxetine , fluoxetine , and sertraline groups differed significantly ( p < 0.001 , p < 0.001 , p = 0.017 , respectively ) from placebo but the fluvoxamine group did not ( p = 0.38 ) . Compared with baseline , paroxetine exerted the strongest delay in ejaculation , followed by fluoxetine and sertraline . There was no clinical ly relevant delay in ejaculation with fluvoxamine . In men with lifelong rapid ejaculation , paroxetine  delayed ejaculation most strongly , whereas fluvoxamine delayed ejaculation the least . The second double-blind , placebo-controlled study was carried out in men with lifelong rapid ejaculation ( IELT < or = 1 minute ) and in men with lifelong less-rapid ejaculation ( IELT > 1 minute ) to investigate whether data about SSRI-induced delayed ejaculation in men with rapid ejaculation may be extrapolated to men with less-rapid ejaculation . After measurement of IELT at home ( using a stopwatch ) during a 1-month baseline assessment , 32 men with an IELT of 1 minute or less ( group 1 ) or more than 1 minute ( group 2 ) were r and omly assigned to receive paroxetine 20 mg/day or placebo for 6 weeks in a double-blind manner . Patients continued to measure their IELTs at home during the 6 weeks of the study . At baseline , 24 patients consistently had IELTs of one minute or less ( group 1 ) , and eight patients had IELTs of more than 1 minute ( group 2 ) . The geometric mean IELT was 14 seconds in group 1 and 83 seconds in group 2 . Twelve patients in group 1 and five in group 2 were r and omized to the paroxetine 20 mg/day . The percentage increase in the geometric mean IELT compared with baseline in patients treated with paroxetine was 420 % ( 95 % confidence interval [ CI ] , 216 - 758 % ) in group 1 and 480 % ( 95 % CI , 177 - 1,118 % ) in group 2 ( p = 0.81 ) . After 6 weeks of treatment with paroxetine , the geometric mean IELT was 92 seconds in group 1 and 602 seconds in group 2 ( p < 0.001 ) . Therefore , the paroxetine-induced percentage increase in IELT seems to be independent of the baseline IELT . This suggests that ejaculation-delaying side effects of some SSRIs investigated in men with lifelong rapid ejaculation may be generalized to men with less-rapid ejaculation PURPOSE We evaluate the efficacy of paroxetine hydrochloride as needed for the treatment of premature ejaculation . MATERIAL S AND METHOD Study 1 comprised 26 potent men with a mean age of 39.5 years with premature ejaculation who were r and omized to receive 20 mg . oral paroxetine ( group A ) or placebo ( group B ) as needed 3 to 4 hours before planned intercourse in a controlled single-blind crossover trial . Study 2 comprised 42 potent men with a mean age of 40.5 years with premature ejaculation who were r and omized to receive 10 mg . paroxetine daily for 3 weeks and then 20 mg . paroxetine as needed ( group C ) for 4 weeks or placebo daily for 3 weeks and then placebo as needed ( group D ) for 4 weeks . RESULTS Mean pretreatment ejaculatory latency time was 0.3 minute for study 1 . At 4 weeks mean ejaculatory latency time was 3.2 minutes in the paroxetine as needed and 0.45 in the placebo as needed phase for group A ( p < 0.001 ) , and 0.6 in the placebo as needed and 3.5 in the paroxetine as needed phase for group B ( p < 0.001 ) . There were no adverse effects with paroxetine or placebo in study 1 . Mean pretreatment ejaculatory latency time was 0.5 minute for study 2 . At 3 weeks mean ejaculatory latency time was 4.3 minutes in the paroxetine daily and 5.8 in the paroxetine as needed phase , and 0.9 in the placebo daily and 0.6 in the placebo as needed phase for group C ( p < 0.001 ) . At 3 weeks mean ejaculatory latency time was 0.8 minutes in the placebo daily and 1.1 in the placebo as needed phase , and 3.3 in the paroxetine daily and 6.1 in the paroxetine as needed phase for group D ( p < 0.001 ) . Adverse effects in 7 of 42 men ( 17 % ) given paroxetine daily included an ejaculation in 3 , anorexia in 1 , gastrointestinal upset in 3 and reduced libido in 2 . Mean ejaculatory latency time was greater in the paroxetine as needed phase of study 2 than that of study 1 ( p < 0.05 ) , suggesting that ejaculatory control achieved with paroxetine as needed is significantly better if patients are initially treated with the drug daily . CONCLUSIONS Paroxetine appears to be superior to placebo in the pharmacological treatment of premature ejaculation when administered on a chronic or as needed basis To evaluate the overall treatment benefit of dapoxetine for  premature ejaculation ( PE )  , with specific emphasis on improvements in personal distress and interpersonal difficulty related to ejaculation .  Although these factors are key elements of numerous sets of diagnostic criteria for PE , they have rarely been evaluated as outcome measures in clinical trials We investigated safety and efficacy of vardenafil and sertraline in  premature ejaculation ( PE ) . Seventy‐two men grade d their primary PE on a scale of 0–8 ( 0 = almost never , 8 = almost always ) . Intravaginal ejaculatory latency time ( IELT ) was measured . Patients were included if they scored their PE as 4 or greater and their IELTs were less than 1.30 min . After 6 weeks of behavioural psychosexual therapy , 49 patients still had a PE of 4 or greater and an IELT less than 1.30 min and they were r and omised : 6 weeks vardenafil ( 10 mg ) or sertraline ( 50 mg ) . After a wash‐out phase for 1 week , medication was changed in a cross‐over design . Initially , all 72 men with PE  received behavioural therapy .  Twenty‐three men were satisfied with treatment and excluded . The remaining 49 men grade d their PE as 5.94 ± 1.6 and IELT was 0.59 min and patients were r and omised . Four men discontinued the study  . Vardenafil  improved PE grading : 2.7 ± 2.1 ( P < 0.01 ) and IELT increased to 5.01 ± 3.69 ( P < 0.001 ) . PE grading improved 1.92 ± 1.32 , ( P < 0.01 ) and IELT 3.12 ± 1.89 ( P < 0.001 ) with sertraline . It is concluded that vardenafil and sertraline are useful agents in the pharmacological treatment of PE INTRODUCTION There is partial evidence to support the use of phophodiesterase-5 inhibitor ( PDE5-I ) for the treatment of  premature ejaculation ( PE ) . AIM We compared on-dem and dosing of dapoxetine alone and combined with mirodenafil in subjects with lifelong PE and without erectile dysfunction ( ED ) . METHODS Our prospect i ve , r and omized , double-blind , placebo-controlled , multicenter trial enrolled 118 subjects with lifelong PE without ED . PE was diagnosed using Diagnostic and Statistical Manual of Mental Disorders , fourth edition , text revision . Patients were divided into two groups : dapoxetine 30 mg plus placebo ( group A , n=56 ) and dapoxetine 30 mg plus mirodenafil 50 mg ( group B , n=62 ) . MAIN OUTCOME MEASURES During 12 weeks , intravaginal ejaculatory latency time ( IELT ) and the time from foreplay to beginning intercourse ( FTIT ) with a stopwatch , and Premature Ejaculation Profile ( PEP ) were measured . Overall sexual act time ( OSAT ; sum of FTIT and IELT ) was calculated . Any treatment-emergent adverse events ( TEAEs ) were also recorded . RESULTS Over 12 weeks , IELT , OSAT , and PEP index score significantly improved in group B compared with group A ( increased geometric mean IELT in group A and B=3.6 and 6.1 minutes , P=0.026 ; increased geometric mean OSAT in group A and B=5.5 and 9.9 minutes , P=0.012 ; increased median PEP index score in group A and B=1.0 and 1.3 , P=0.046 ) . However , there was no significant difference between two groups with respect to improvement of FTIT ( P=0.147 ) . TEAEs did not differ between groups ( all P>0.05 ) , and there was no serious adverse event in any subjects . CONCLUSIONS Low dose of dapoxetine combined with mirodenafil showed better results in terms of IELT , OSAT , and PEP index score , and similar TEAEs , compared with that of dapoxetine only . Our results support the suggestion that the PDE5-Is have a potential role in the treatment of PE without ED Antidepressant medication is often associated with sexual side effects . A double-blind , placebo-controlled study in men with lifelong rapid ejaculation was performed to assess the effects of two selective serotonin ( 5-HT ) reuptake inhibitors — paroxetine and sertraline— and the 5-HT 2 antagonist and 5-HT/noradrenaline reuptake inhibitor nefazodone on the latency to ejaculate . Forty-eight men with an intravaginal ejaculation latency time ( IELT ) of a maximum of 1 minute were r and omly assigned to receive paroxetine ( 20 mg/day ) , sertraline ( 50 mg/day ) , nefazodone ( 400 mg/day ) , or placebo for 6 weeks . During the 1-month baseline and 6-week treatment period , IELTs were measured at home with a stopwatch . The trial was completed by 40 men . During the 6-week treatment period , the geometric mean IELT in the placebo group was stable at approximately 20 seconds . Analysis of variance revealed a between-group difference in the evolution of IELT delay over time ( p = 0.002 ) ; the IELT after paroxetine and sertraline gradually increased to approximately 146 and 58 seconds , respectively , compared with 28 seconds in the nefazodone group . The paroxetine and sertraline groups differed significantly ( p < 0.001 and p = 0.024 , respectively ) from placebo , but the nefazodone group did not ( p = 0.85 ) . Compared with baseline , paroxetine exerted the strongest delay in ejaculation , whereas sertraline delayed it only moderately . There was no clinical ly relevant delay in ejaculation with nefazodone INTRODUCTION Men with comorbid erectile dysfunction ( ED ) and premature ejaculation ( PE ) may be concomitantly prescribed a phosphodiesterase type 5 ( PDE5 ) inhibitor and dapoxetine . AIM Evaluate efficacy and safety of dapoxetine 30 mg and 60 mg on dem and ( prn ) in men with PE and ED who were being treated with PDE5 inhibitors . METHODS This r and omized , double-blind , placebo-controlled , flexible-dose , multicenter study enrolled men ≥18 years who met diagnostic criteria for PE including intravaginal ejaculatory latency time ( IELT ) of ≤2 minutes in ≥75 % of sexual intercourse episodes ; were on stable regimen of a PDE5 inhibitor ; and had International Index of Erectile Function-erectile function domain score ≥21 . Subjects received placebo , dapoxetine 30 mg , or dapoxetine 60 mg prn ( 1 - 3 hours before intercourse ) for 12 weeks . MAIN OUTCOME MEASURE Stopwatch-measured average IELT , Clinical Global Impression of Change ( CGIC ) in PE , Premature Ejaculation Profile ( PEP ) , and treatment-emergent adverse events ( TEAEs ) . RESULTS Of 495 subjects r and omized , 429 completed the study . Arithmetic mean average IELT significantly increased with dapoxetine vs. placebo at end point ( 5.2 vs. 3.4 minutes ) and weeks 4 , 8 , and 12 ( P ≤ 0.002 for all ) . Men who described their PE at least " better " using the CGIC were significantly greater with dapoxetine vs. placebo at end point ( 56.5 % vs. 35.4 % ) and weeks 4 , 8 , and 12 ( P ≤ 0.001 for all ) . Significantly better outcomes were also reported with dapoxetine vs.  placebo on PEP measures . Incidence of TEAEs was 20.0 % and 29.6 % in placebo- and dapoxetine-treated subjects , respectively ( P = 0.0135 ) . TEAEs led to discontinuation in 1.6 % of subjects in both groups . Most frequent TEAEs were known adverse drug reactions of dapoxetine treatment including nausea ( 9.2 % ) , headache ( 4.4 % ) , diarrhea ( 3.6 % ) , dizziness ( 2.4 % ) , and dizziness postural ( 2.4 % ) . CONCLUSIONS In men with PE and comorbid ED on a stable regimen of PDE5 inhibitor , dapoxetine provided meaningful treatment benefit and was generally well tolerated OBJECTIVES To compare the efficacy of sildenafil ( Viagra ) only , sildenafil plus topical anesthetic cream ( EMLA ) , and topical EMLA-cream-only to that of placebo in treating  premature ejaculation .  METHODS A total of 84 patients were enrolled in this study . The duration of premature ejaculation in the patients ranged from 9 to 60 months ( mean 32.5 + /- 14.6 ) . Patients were r and omized into four groups . Group 1 consisted of 20 patients who took placebo for 2 months . Groups 2 and 3 consisted of 20 and 22 patients , respectively , and they received 50 mg sildenafil 45 minutes before coitus for 2 months . In addition , patients in group 3 applied topical EMLA cream to the glans penis 15 minutes before coitus . The 22 patients in group 4 used topical EMLA-cream-only . After at least eight sexual attempts , the patients ' clinical responses were assessed using the patient self-description method . Effectiveness was described as improvement plus cure . RESULTS The effectiveness was 40 % in group 1 , 55 % in group 2 , 86.4 % in group 3 , and 77.3 % in group 4 . Of the groups , a significant difference was found in the effectiveness of the treatments ( Pearson chi-square= 0.00 ) . No significant difference was found between groups 1 and 2 ( P = 0.26 ) . Efficacy was more successful in groups 3 and 4 than in the others ( P = 0.00 ) . The difference between groups 3 and 4 was not significant ( Pearson chi-square = 0.42 ) . CONCLUSIONS Sildenafil-only was not superior to placebo or combination treatment . Topical EMLA-cream-only had equal effectiveness to that of sildenafil plus topical EMLA treatment . The use of topical EMLA-cream-only seems to be an effective treatment of premature ejaculation This study investigated the efficacy and the adverse effects of sertraline in the treatment of premature ejaculation ( PE ) . Thirty-seven patients with PE were r and omly assigned to receive either sertraline or a placebo . Of them 22 were given 50 mg of sertraline per day and the other 15 patients were given an identical placebo one per day . After 4 weeks , the latency to ejaculation in the sertraline group was found to be significantly longer than that of the placebo group ( p<0.01 ) . None of the patients discontinued therapy due to adverse effects . These results indicate that  sertraline is an effective therapy for PE We aim ed to evaluate the effectiveness of paroxetine and tadalafil combination in the treatment of  premature ejaculation ( PE ) . A total of 150 primary (lifelong)PE patients were r and omly distributed into three groups of 50 patients each . Group 1 received 20 mg paroxetine every day for 1 month , Group 2 received 20 mg tadalafil on dem and 2 h before intercourse , and Group 3 received paroxetine and tadalafil on dem and 2 h before intercourse . Intravaginal ejaculatory latency times ( IELT ) scores were evaluated at baseline , at the end of the first month of therapy and 1 month after discontinuation of the treatment , while International Index of Erectile Function ( IIEF ) question naire scores were evaluated both prior to and after the treatment . At the end of the first month of therapy , IELT scores were compared with the basal values and statistically significant changes were detected ( 60.6 ± 30.2–117.3 ± 67.3 , 68.5 ± 21.4–110.2 ± 37.3 , 71.56 ± 40.23–175.2 ± 60.2)(P < 0.01 ) . IELT scores after discontinuation of treatment were found to be close to the baseline IELT scores ( P > 0.05 ) . IIEF scores were evaluated both prior to and after the treatment , and no statistically significant difference was detected ( P > 0.05 ) . It is concluded that utilisation of selective serotonin reuptake inhibitors ( SSRI ) and phosphodiesterase‐5 inhibitors ( PDE5i ) combination before intercourse seems to provide significantly longer ejaculatory latency times as compared with SSRI alone for a long time in patients with PE Objective The aim of this study is to measure the ejaculation latency time ( ELT ) and to evaluate the effects of vardenafil on ELT and rigidity parameters of patients with lifelong premature ejaculation ( PE ) in a laboratory setting . Material s and methods Double-blind , placebo-controlled , cross-over laboratory study was performed with 40 males with lifelong PE . As the subject ingested the placebo or vardenafil , real-time penile tumescence and rigidity monitoring began . Audiovisual sexual stimulation ( AVSS ) was performed 45 min later . The patient began vibratory stimulation to the frenular area at 8th minute of AVSS till ejaculation . A button has been placed under the cover where the patient presses to operate the vibrator . ELT was calculated in seconds with a chronometer . Following ejaculation , AVSS was stopped . The test was repeated with second medication in 7–15 days . Results Among 40 patients , the results of 17 could be evaluated . When the patient took placebo and vardenafil , mean ELTs were 62.7 and 189.5 s , respectively . When compared with placebo , vardenafil  improved ELT significantly ( P = 0.04 ) . After the beginning of AVSS , time to first recorded base or tip rigidities was shorter and time to last recorded tip or base rigidities following ejaculation was longer than placebo ; however , these differences were not significant ( P > 0.05 for each ) . Conclusions This laboratory design might be used to evaluate the effects of drugs on patients with ejaculation disorders . In this laboratory setting study , vardenafil exerted a threefold increase in ejaculation delay outside the vagina in patients with lifelong PE Introduction : Premature ejaculation ( PE ) is a common male sexual disorder . An ideal , reliable and effective treatment is desired by many men and couples affected by this condition . Aim : Evaluate if the association of a phosphodiesterase-5 inhibitor , tadalafil , and a selective serotonin reuptake inhibitor , fluoxetine , can prolong the intravaginal ejaculatory latency time ( IELT ) in men with lifelong premature ejaculation . Methods : Sixty patients with lifelong premature ejaculation and without erectile dysfunction ( ED ) with IELT less than 90 s were enrolled in the protocol and r and omized into 4 groups to use a combination of medications : ( 1 ) tadalafil 20 mg plus fluoxetine 90 mg , ( 2 ) fluoxetine 90 mg plus placebo , ( 3 ) tadalafil 20 mg plus placebo , and ( 4 ) two different placebo capsules ( control ) . Before starting the medications , each man timed his IELT with a stopwatch , and likewise during the treatment period . Fluoxetine 90 mg or placebo was taken once a week plus tadalafil 20 mg or placebo within a 36-hour frame of intended sexual intercourse with a steady partner . Patients were prospect ively followed for 12 weeks . One-way ANOVA was used for statistical comparisons of IELT results in each group . Results : Mean IELT before starting treatment was 51.3 ± 23 s. Withone-way ANOVA , a statistically significant difference in post-treatment IELT was seen with combination treatment compared to placebo ( p < 0.001 ) . There were increases in IELT from baseline in patients using fluoxetine plus tadalafil ( 49.57 ± 25.87 to 336.13 ± 224.77 ) ( p < 0.001 ) , fluoxetine ( 56.55 ± 18.55 to 233.62 ± 105.08 ) ( p < 0.001 ) and tadalafil ( 49.26 ± 19.43 to 186.53 ± 159.05 ) ( p = 0.001 ) . The increases in each group were statistically significant compared to the placebo ( 49.86 ± 19.43 to 67.82 ± 46.18 ) ( p = 0.042 ) . Conclusion : Fluoxetine plus tadalafil significantly increased the IELT from baseline in men with lifelong premature ejaculation when compared to placebo , tadalafil or fluoxetine Introduction : The aim of this study was to compare the efficacy of fluoxetine alone and combined with sildenafil in patients complaining of premature ejaculation . Patients and Methods : Ninety-one married potent men , 21–43 years old , with premature ejaculation but without any obvious organic cause were enrolled . Pretreatment evaluation included history , physical examination , and self-administration of the International Index of Erectile Function question naire . The patients were r and omly divided into two groups : group A patients ( n = 48 ) received 20 mg fluoxetine daily for 4 weeks and then 20 mg as needed 2–3 h before sexual activity for 4 months , and group B patients ( n = 43 ) received group A regimen plus 50 mg sildenafil as needed 1 h before sexual activity for 4 months . Results : Ejaculatory latency time and intercourse satisfaction significantly improved in group B as compared with group A ( p < 0.05 ) . Conclusion : Fluoxetine combined with sildenafil seems to provide significantly better ejaculatory latency time and intercourse satisfaction as compared with fluoxetine alone in patients with premature ejaculation BACKGROUND Recently , sildenafil has been demonstrated to be effective in treating  premature ejaculation ( PE ) .  However , these studies ignored female factors and could not exclude the probability of drug interaction when combined with paroxetine . Therefore , the aim of this study was to evaluate the efficacy and safety of sildenafil alone in the treatment of primary PE , taking female factors into consideration . METHODS One hundred and eighty potent men with primary PE were r and omly divided into three groups and followed up for 6 months . Group A were treated with 50 mg sildenafil as needed , group B with 20 mg paroxetine daily and group C with squeeze technique daily .  Intravaginal ejaculatory latency time ( IELT ) , PE grade , intercourse satisfactory score ( ISS ) , frequency of intercourse , and adverse effects of drugs were recorded before treatment , and 3 and 6 months after treatment . RESULTS Compared with pretreatment , the three groups had significant differences in all the parameters after 3 or 6 months treatment , except the frequency of intercourse in Group C ( all P = 0.00 ) . However , there were no significant differences between 3 and 6 months . Compared with paroxetine and squeeze technique , after 3 or 6 months , sildenafil had significant differences in all the parameters ( all P = 0.00 ) . After 6 months , 1.7 % , 18.3 % and 36.7 % patients in groups A , B and C , respectively , withdrew from the study and 86.7 % , 60.0 % and 45.0 % patients , respectively , wanted to be treated further with the original administration , and this was statistically significant ( both P = 0.00 ) . CONCLUSION Sildenafil is very effective and safe to treat PE , and has much higher efficacy than paroxetine and squeeze technique OBJECTIVE To compare the efficacy and safety of sildenafil plus sertraline with those of sertraline alone in the treatment of premature ejaculation ( PE ) . METHODS Seventy-two patients with PE but without any obvious organic cause were enrolled in this study . They were r and omly divided into Groups A and B of equal number . Group A received 50 mg sertraline daily 4 to 6 hours before planned sexual activity for 12 weeks , and Group B were given 50 mg sertraline daily plus 50 mg sildenafil as needed , 1 hour before planned sexual activity , for 12 weeks . Before and after the treatment , the mean intravaginal ejaculation latency time , the intercourse satisfaction , the mean number of coituses per week and the drug-related side effects were evaluated . RESULTS The mean intravaginal ejaculatory latency time was ( 0.59 + /- 0.12 ) , ( 3.9 + /- 0.15 ) minutes ( P < 0.001 ) at baseline and post-treatment in Group A , and ( 0.56 + /- 0.11 ) , ( 5.6 + /- 0.12 ) minutes ( P < 0.001 ) in Group B , improved in both of the 2 groups , but more significantly in Group B ( P < 0.05 ) . Before and after the treatment , the mean intercourse satisfaction domain values of the IIEF were ( 8.9 + /- 1.2 ) , ( 10.8 + /- 1.1 ) ( P < 0.05 ) and ( 8.8 + /- 1.1 ) , ( 13.8 + /- 1.3 ) ( P < 0.001 ) in Groups A and B , respectively , significantly greater in Group B than in Group A ( P < 0.05 ) after the treatment ; the mean numbers of coituses per week in Groups A and B were ( 0.9 + /- 0.2 ) , ( 1.9 + /- 0.3 ) ( P < 0.05 ) and ( 1.0 + /- 0.2 ) , ( 2.7 + /- 0.2 ) ( P < 0.001 ) respectively , significantly larger in Group B ( P<0.05 ) after the treatment . As for the side effects , there was a higher rate of headaches ( P < 0.01 ) and flushing episodes ( P < 0.001 ) in Group B than in Group A. CONCLUSION Sertraline combined with sildenafil can produce significantly better results than sertraline alone in patients with premature ejaculation .  However , the combined treatment is associated with a slight increase in the drug-related side effects INTRODUCTION Intravaginal ejaculation  latency time ( IELT ) , defined as the time between the start of vaginal intromission and the start of intravaginal ejaculation , is increasingly used in clinical trials to assess the amount of selective serotonin reuptake inhibitor-induced ejaculation delay in men with premature ejaculation . Prospect ively , stopwatch assessment of IELTs has superior accuracy compared with retrospective question naire and spontaneous reported latency . However , the IELT distribution in the general male population has not been previously assessed . AIM To determine the stopwatch assessed-IELT distribution in large r and om male cohorts of different countries . METHODS A total of 500 couples were recruited from five countries : the Netherl and s , United Kingdom , Spain , Turkey , and the United States . Enrolled men were aged 18 years or older , had a stable heterosexual relationship for at least 6 months , with regular sexual intercourse . The surveyed population were not included or excluded by their ejaculatory status and comorbidities . This survey was performed on a " normal " general population .  Sexual events and stopwatch-timed IELTs during a 4-week period were recorded , as well as circumcision status and condom use . MAIN OUTCOME MEASURES The IELT , circumcision status , and condom use . RESULTS The distribution of the IELT in all the five countries was positively skewed , with a median IELT of 5.4 minutes ( range , 0.55 - 44.1 minutes ) . The median IELT decreased significantly with age , from 6.5 minutes in the 18 - 30 years group , to 4.3 minutes in the group older than 51 years ( P<0.0001 ) . The median IELT varied between countries , with the median value for Turkey being the lowest , i.e. , 3.7 minutes ( 0.9 - 30.4 minutes ) , which was significantly different from each of the other countries . Comparison of circumcised ( N=98 ) and not-circumcised ( N=261 ) men in countries excluding Turkey result ed in median IELT values of 6.7 minutes ( 0.7 - 44.1 minutes ) in circumcised compared with 6.0 minutes ( 0.5 - 37.4 minutes ) in not-circumcised men ( not significant ) . The median IELT value was not affected by condom use . CONCLUSION The IELT distribution is positively skewed . The overall median value was 5.4 minutes but with differences between countries . For all five countries , median IELT values were independent of condom usage . In countries excluding Turkey , the median IELT values were independent of circumcision status
target: Conclusions PDE5Is were significantly more effective than placebo or SSRIs for treating PE , while SSRIs were better than placebo .
  The combined treatment had better efficacy than PDE5Is or SSRIs alone
background: Purpose To clarify the efficacy of phosphodiesterase-5 inhibitors ( PDE5Is ) and selective serotonin reuptake inhibitors ( SSRIs ) in men with premature ejaculation ( PE ) .