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Sexual Encounter Profile (sexual + encounter_profile)
Selected AbstractsEfficacy and safety of on-demand tadalafil for the treatment of erectile dysfunction in South-East Asian menINTERNATIONAL JOURNAL OF UROLOGY, Issue 6 2006YING LU GUO Aim:, Tadalafil is an inhibitor of phosphodiesterase type 5 used for the treatment of erectile dysfunction (ED). The efficacy and safety of tadalafil have been evaluated extensively in Western populations. Our aim was to assess the efficacy and safety of on-demand tadalafil for the treatment of ED in South-East Asian men. Methods:, This was a randomized, double-blind, placebo-controlled study of men with mild to severe ED of various etiologies randomized to receive placebo (n = 122), tadalafil 10 mg (n = 120), or tadalafil 20 mg (n = 125), taken as needed (maximum once daily) for 12 weeks. Efficacy assessments included the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and a Global Assessment Question (GAQ). Results:, Men from China, Singapore, and the Philippines participated in this trial (n = 367). Compared with placebo, tadalafil significantly improved erectile dysfunction on all efficacy outcomes (P < 0.001). Patients receiving tadalafil 10 mg and 20 mg experienced a significant mean improvement of 8.1 and 8.7, respectively, in the IIEF Erectile Function (IIEF-EF) domain score from baseline (vs placebo 2.4, P < 0.001). In patients receiving tadalafil 10 mg and 20 mg, the mean per-patient success rate for intercourse attempts (SEP3) was 62% and 70%, respectively, compared with 32% for the placebo group (P < 0.001). Of patients who received tadalafil 10 mg and 20 mg, 81% and 86% reported improved erections at endpoint (GAQ) compared with 44% in the placebo group (P < 0.001). The most common adverse events reported by patients were headache, back pain, dyspepsia, and dizziness. Conclusions:, Tadalafil was an effective and well-tolerated treatment for South-East Asian men with ED. [source] Efficacy and Safety of Tadalafil 20 mg on Demand vs.THE JOURNAL OF SEXUAL MEDICINE, Issue 8 2010Tadalafil 5 mg Once-a-Day in the Treatment of Post-Radiotherapy Erectile Dysfunction in Prostate Cancer Men: A Randomized Phase II Trial ABSTRACT Introduction., The role of phosphodiesterase type 5 inhibitors in the treatment of post-radiotherapy erectile dysfunction (ED) has not been extensively investigated. Aim., To compare the efficacy and safety of on-demand 20-mg tadalafil (arm A) with the newly released tadalafil 5-mg once-a-day dosing (arm B) in patients with ED following radiotherapy for prostate cancer (PC). Methods., Randomized study to receive on-demand 20-mg or once-a-day 5-mg tadalafil for 12 weeks. Main Outcome Measures., Changes in the International Index of Erectile Function (IIEF) domain scores and Sexual Encounter Profile (SEP) question 2 and 3 positive response rates. Results., Fifty-two out of 86 screened patients were randomized. Forty-four patients were evaluable for efficacy. A significant improvement in all domains of the IIEF was observed in both arms (P = 0.0001) with mean erectile function domain scores values of 25 and 27.1 for the 20-mg and 5-mg tadalafil, respectively (P = 0.19). SEP 2 and 3 positive response rates increased from 0% in both arms at baseline to 81% and 70% in the 20-mg arm and 90% and 73% in the 5-mg arm, respectively, at the end of treatment (P = 0.27). End of treatment global efficacy question positive answers were 86% in the 20-mg arm and 95% in the 5-mg arm (P = 0.27). Higher treatment compliance was shown in arm B (100%) as compared with arm A (86%). There was a nonstatistically significant trend toward fewer side effects in favor of the 5-mg daily dose arm. Conclusions., In the study population, both tadalafil formulations generated significantly high response rates according to the outcome measures and were well tolerated. The once-a-day 5-mg dosing showed higher compliance and marginally reduced side effects, thus making it an attractive alternative to on-demand therapy for ED in post-radiotherapy PC patients. Ricardi U, Gontero P, Ciammella P, Badellino S, Valentino F, Munoz F, Guarneri A, Rondi N, Moretto F, Filippi AR, Ragona R, and Tizzani A. Efficacy and safety of tadalafil 20 mg on demand vs. tadalafil 5 mg once-a-day in the treatment of post-radiotherapy erectile dysfunction in prostate cancer men: A randomized phase II trial. J Sex Med 2010;7:2851,2859. [source] Efficacy of Phosphodiesterase Type 5 Inhibitor Treatment in Men with Erectile Dysfunction and Dyslipidemia: A Post Hoc Analysis of the Vardenafil Statin StudyTHE JOURNAL OF SEXUAL MEDICINE, Issue 5 2010Martin M. Miner MD ABSTRACT Introduction., Dyslipidemia occurs often in subjects with erectile dysfunction (ED), but there is little information about how this condition affects ED treatment responses. Aim., To determine whether low-density lipoprotein cholesterol (LDL-C) levels, total cholesterol (TC)/high-density lipoprotein cholesterol (HDL-C) ratio; or the presence of metabolic syndrome influenced efficacy of vardenafil in men with ED and dyslipidemia. Methods., Post hoc subgroup analysis of a 12-week study of the influence of lipid levels and presence of metabolic syndrome on the efficacy of vardenafil as measured by International Index of Erectile Function-Erectile Function (IIEF-EF) domain score, responses to Sexual Encounter Profile (SEP) SEP2 and SEP3 questions, duration of erection leading to successful intercourse, and erection duration regardless of the answer to SEP3. Lipid values were obtained at study start, after patients had received at least 3 months of therapy with a statin. Main Outcome Measures., Outcomes in subjects with LDL-C <100, ,100 to <130, or ,130 mg/dL [<2.59, ,2.59 to <3.36, or ,3.36 mmol/L]; TC/HDL-C ratio <3.5 vs. ,3.5, and presence or absence of metabolic syndrome. Results., Vardenafil improved all endpoints evaluated compared with placebo in all subgroups, however, nominally significant treatment by subgroup interaction terms did not follow a distinct pattern. Increasing LDL-C (P = 0.033), but not TC/HDL-C ratio or metabolic syndrome, was associated with an increase in treatment response measured by the IIEF-EF domain score. Responses to SEP3 were nominally influenced by LDL-C levels (P = 0.019), but were not significantly influenced by TC/HDL-C ratio, or the metabolic syndrome. Only higher TC/HDL-C ratios (,3.5) were associated with larger treatment differences in duration of erection leading to successful intercourse (P = 0.028). Conclusions., Vardenafil was effective in men with dyslipidemia regardless of LDL-C levels, TC/HDL-C ratio, and/or presence of metabolic syndrome. Despite the known presence of ED and dyslipidemia, other cardiovascular risk factors were apparently not aggressively managed. Miner MM, Barnes A, and Janning S. Efficacy of phosphodiesterase type 5 inhibitor treatment in men with erectile dysfunction and dyslipidemia: A post hoc analysis of the vardenafil statin study. J Sex Med 2010;7:1937,1947. [source] Efficacy and Tolerability of Lodenafil Carbonate for Oral Therapy in Erectile Dysfunction: A Phase II Clinical TrialTHE JOURNAL OF SEXUAL MEDICINE, Issue 2 2009Sidney Glina MD ABSTRACT Introduction., Oral treatment with phosphodiesterase type 5 inhibitor (PDE5) is considered the first-line treatment for patients with erectile dysfunction (ED). Lodenafil carbonate (LC) is a novel PDE5. Aim., This is a phase II, prospective, randomized, double-blind, and placebo controlled clinical trial of LC. Main Outcome Measures., Efficacy end points were International Index of Sexual Function (IIEF) erectile domain, IIEF questions 3 and 4, and Sexual Encounter Profile (SEP) questions 2 and 3, before and after the use of LC or placebo. Methods., Seventy-two men older than 18 years, with ED for at least 6 months with stable sexual relationship were enrolled. Patients were randomized to placebo or LC 80 mg, 40 mg, or 20 mg and followed for 4 weeks. Results., IIEF erectile domain scores before and after the use of medications were (mean ± standard deviation [SD]): placebo: 11.9 ± 3.4 and 12.6 ± 5.5; LC 20 mg: 15.8 ± 4.1 and 18.9 ± 6.6; LC 40 mg: 11.9 ± 4.4 and 15.4 ± 8.1; LC 80 mg: 14.2 ± 4.7 and 22.8 ± 6.0 (anovaP < 0.01). The SEP-2 scores before and after the use of medications were (Mean ± SD): placebo: 71.0 ± 33.1 and 51.2 ± 43.1; LC 20 mg 70.3 ± 34.2 and 75.5 ± 31.5; LC 40 mg: 48.4 ± 42.1 and 60.8 ± 42.5; LC 80 mg: 68.6 ± 33.5 and 89.6 ± 26.0. The SEP-3 scores were: placebo 23.3 ± 27.6 and 33.6 ± 42.3; LC 20 mg: 32.3 ± 38.9 and 51.2 ± 41.7; LC 40 mg: 39.7 ± 44.7 and 46.7 ± 41.1; LC 80 mg* 17.2 ± 29.5 and 74.3 ± 36.4 (*P < 0.05 for difference to placebo). Conclusions., The drug was well tolerated. Adverse reactions were mild and self-limited and included headache, rhinitis, flushing, color visual disorders, and dyspepsia. This study showed that the dosage of 80 mg of LC was significantly more efficacious than placebo and well tolerated. Glina S, Toscano I, Gomatzky C, de Góes PM, Jśnior AN, de Almeida Claro JF, and Pagani E. Efficacy and tolerability of lodenafil carbonate for oral therapy in erectile dysfunction: A phase II clinical trial. J Sex Med 2009;6:553,557. [source] Vardenafil Restores Erectile Function to Normal Range in Men with Erectile DysfunctionTHE JOURNAL OF SEXUAL MEDICINE, Issue 1 2007Harin Padma-Nathan MD ABSTRACT Introduction., The ability of oral phosphodiesterase type 5 (PDE5) inhibitor therapy to restore erectile function to normal is an important attribute to men with erectile dysfunction (ED). Aim., To assess the ability of vardenafil to restore normal erectile function in men with general ED. Methods., In two fixed-dose, parallel-group, double-blind, placebo-controlled, pivotal studies, patients received vardenafil (5, 10, or 20 mg) or placebo for 12/26 weeks. Main Outcome Measure., In this retrospective analysis, the percentage of patients "returning to normal" erectile function at week 12 (as defined by scores ,26 on erectile function domain of International Index of Erectile Function [IIEF-EF]) was determined, with further stratification by baseline ED severity, etiology, age, and duration of ED. Results., Vardenafil 5, 10, and 20 mg returned 32%, 43%, and 49% of patients, respectively, to normal erectile function after 12 weeks, compared with 10% of patients receiving placebo (P < 0.0001). Return to normal IIEF-EF domain scores was noted irrespective of severity, etiology, age, and duration of ED, and was observed even in challenging-to-treat subgroups. With vardenafil 20 mg, 39% of men with severe ED at baseline, 45,49% of men with ED of mixed or organic etiology, 35% of men aged ,65 years, and 43% of men with ED of ,3 years of duration returned to normal erectile function at week 12. Mean per-patient SEP3 (question 3 on the Sexual Encounter Profile) success rates in patients achieving IIEF-EF domain scores ,26 ranged from 87% to 95%. Conclusion., Vardenafil improves the IIEF-EF domain score to the normal range in a substantial proportion of men with ED. Padma-Nathan H, Montorsi F, Giuliano F, Meuleman E, Auerbach S, Eardley I, McCullough A, Homering M, and Segerson T for the North American and European Vardenafil Study Group. Vardenafil restores erectile function to normal range in men with erectile dysfunction. J Sex Med 2007;4:152,161. [source] Efficacy and Safety of Two Dosing Regimens of Tadalafil and Patterns of Sexual Activity in Men with Diabetes Mellitus and Erectile Dysfunction: Scheduled Use vs.THE JOURNAL OF SEXUAL MEDICINE, Issue 3 2006On-Demand Regimen Evaluation (SURE) Study in 14 European Countries ABSTRACT Aim., The aim of this article is to evaluate the efficacy and safety of 20-mg tadalafil taken on demand or three times per week and its effect on the sexual activity of patients with diabetes mellitus and erectile dysfunction (ED). Methods., The scheduled use vs. on-demand regimen evaluation (SURE) was a randomized, crossover, open-label study with 4,262 patients in 14 European countries. The efficacy measures for the 762 patients with diabetes and ED included changes from baseline in the erectile function (EF) domain of the International Index of Erectile Function (IIEF), and the proportion of "yes" responses to patient Sexual Encounter Profile (SEP) questions 2 (SEP2) and 3 (SEP3). The treatment satisfaction was measured with responses to SEP question 4 (SEP4) and SEP question 5 (SEP5), and sexual attempts data were collected. Patient preference for either regimen was determined by the treatment preference question (TPQ). Results., At end point on both regimens, the mean IIEF EF domain score was 22, and >40% of the patients had a normal EF domain score (,26). The proportion of "yes" responses was ,73% for SEP2 (penetration), ,58% for SEP3 (successful intercourse), >46% for SEP4 (hardness of erection), and ,45% for SEP5 (overall satisfaction). Efficacy was maintained up to 36 hours post-dosing. More than 70% of sexual attempts while on the three-times-per-week regimen and approximately 50% of the attempts on the on-demand treatment occurred >4 hours post-dosing. Tadalafil was well tolerated, with dyspepsia and headache as the most frequent adverse events reported. Treatment preference was 57.2% for on demand and 42.8% for three times per week. Conclusions., Tadalafil, when taken on demand or three times per week, is efficacious and safe in men with diabetes and ED. Buvat J, van Ahlen H, Schmitt H, Chan M, Kuepfer C, and Varanese L. Efficacy and safety of two dosing regimens of tadalafil and patterns of sexual activity in men with diabetes mellitus and erectile dysfunction: Scheduled use vs. on-demand regimen evaluation (SURE) study in 14 European countries. J Sex Med 2006;3:512,520. [source] Efficacy and Safety of On-Demand Oral Tadalafil in the Treatment of Men with Erectile Dysfunction in Taiwan: A Randomized, Double-Blind, Parallel, Placebo-Controlled Clinical StudyTHE JOURNAL OF SEXUAL MEDICINE, Issue 2 2004Kuang-Kuo Chen MD Conflict of Interest. Timothy M. Costigan and Jeffrey T. Emmick are employees of Eli Lilly, Indianapolis. ABSTRACT Introduction., Tadalafil is a phosphodiesterase type 5 inhibitor for the treatment of erectile dysfunction (ED). Past clinical trials have assessed its efficacy and safety in western populations. Tadalafil has not been investigated in a large clinical trial with a South-east Asian population. Aim., To assess the efficacy and safety of on-demand tadalafil for the treatment of ED in a 12-week, double-blind, placebo-controlled study in Taiwan. Methods., Men with mild to severe ED of various etiologies were randomized to receive placebo, tadalafil 10 mg, or tadalafil 20 mg, taken as needed (maximum once daily). Efficacy assessments included the International Index of Erectile Function, the Sexual Encounter Profile (SEP) diary, and a Global Assessment Question (GAQ). Results., Tadalafil significantly improved erectile function compared with placebo (P < 0.005, all measures). At endpoint, the patients receiving tadalafil reported a greater mean per-patient percentage of successful intercourse attempts (SEP question 3: 70.0%, 10 mg; 78.0%, 20 mg) than placebo-treated patients (42.8%) and a greater proportion of improved erections (GAQ: 92.3% and 84.6% vs. 54.5%). Most treatment-emergent adverse events were mild or moderate. The most common adverse events were back pain, dyspepsia, and myalgia. Conclusions., Tadalafil was an effective, well-tolerated therapy for men in Taiwan with ED of broad-spectrum severity and etiology. [source] ORIGINAL RESEARCH,ED PHARMACOTHERAPY: Efficacy and Tolerability of Lodenafil Carbonate for Oral Therapy of Erectile Dysfunction: A Phase III Clinical TrialTHE JOURNAL OF SEXUAL MEDICINE, Issue 5 2010Sidney Glina MD ABSTRACT Introduction., This is a phase III, prospective, randomized, double-blind, placebo-controlled clinical trial on lodenafil carbonate (LC), a novel phosphodiesterase 5 inhibitor developed in Brazil. Aim., Expanding information on LC efficacy and safety. Main Outcome Measures., International Index of Erectile Function (IIEF) erectile domain, positive answers to the sexual encounter profile (SEP)-2 and SEP-3 questions and incidence of adverse events (AEs). Methods., A total of 350 men with erectile dysfunction (ED) of all degrees were randomized to placebo, LC 40 mg or LC 80 mg and followed for 4 weeks. They completed the IIEF and answered the SEP questions 2 and 3 after each intercourse without and with the use of LC. Results., IIEF Erectile Domain scores without and with the use of medication were the following (mean [M] ± standard deviation [SD]): placebo = 13.9 ± 5.2 and 14.8 ± 7.8; LC 40 mg = 13.6 ± 5.3 and 18.6 ± 8.0; LC 80 mg = 13.4 ± 4.9 and 20.6 ± 7.7 (analysis of variance [anova]P < 0.01). Positive answers to SEP-2 without and with the use of medication were the following (M ± SD): placebo = 55.3 ± 43.2% and 52.1 ± 41.4%; LC 40 mg = 46.4 ± 44.3% and 63.5 ± 42.0%; LC 80 mg = 50.2 ± 40.9% and 80.8 ± 32.3% (anovaP < 0.01). Positive answers to SEP-3 were the following: placebo = 20.2 ± 32.3% and 29.7 ± 38.1%; LC 40 mg = 19.6 ± 34.3% and 50.8 ± 44.4%; LC 80 mg = 20.8 ± 33.2% and 66.0 ± 39.3% (anovaP < 0.01). The patients with at least one AE were placebo = 28.7%, LC 40 mg = 40.9%, and LC 80 mg = 49.5%. AEs whose incidence was significantly higher with LC than with placebo included rhinitis, headache, flushing, visual disorder, and dizziness. Conclusions., LC showed a satisfactory efficacy,safety profile for oral therapy of ED. Glina S, Fonseca GN, Bertero EB, Damićo R, Rocha LCA, Jardim CRF, Cairoli CE, Teloken C, Torres LO, Faria GE, da Silva MB, and Pagani E. Efficacy and tolerability of lodenafil carbonate for oral therapy of erectile dysfunction: A phase III clinical trial. J Sex Med 2010;7:1928,1936. [source] | ||||||||||