On-demand tramadol hydrochloride use in premature ejaculation treatment.

To determine the efficacy of tramadol in premature ejaculation (PE) treatment compared with placebo. A single-blind, placebo-controlled, crossover study was conducted with 60 lifelong (primary) patients with PE. The patients were randomized into 2 groups, each consisting of 30 patients, who took tramadol or placebo on demand. PE was defined as an intravaginal ejaculation latency time of ≤60 seconds in 90% of intercourse episodes. The efficacy of the drugs was assessed using the intravaginal ejaculation latency time, ability of ejaculation control, and sexual satisfaction scores after an 8-week treatment period. All participants completed the study voluntarily. Two groups were similar in terms of the patient demographics. Increases in the intravaginal ejaculation latency time, ability of ejaculation control, and sexual satisfaction score between the placebo and tramadol groups were compared with the baseline values in both groups. At the end of study period, the tramadol group had significantly (P<.001) greater values for all 3 parameters compared with those in the placebo group. On-demand use of low-dose tramadol is effective for lifelong PE. Currently, selective seratonin reuptake inhibitors such as dapoxetine, are a more popular treatment option for PE. However, tramadol might be considered an alternative agent for primary PE treatment.

Kaynar M ，Kilic O ，Yurdakul T 《-》

PSD502 improves ejaculatory latency, control and sexual satisfaction when applied topically 5 min before intercourse in men with premature ejaculation: results of a phase III, multicentre, double-blind, placebo-controlled study.

Dinsmore WW ，Wyllie MG 《-》

A randomized double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of two doses of the tramadol orally disintegrating tablet for the treatment of premature ejaculation within less than 2 minutes.

Premature ejaculation (PE) is a widely observed male sexual dysfunction with a major impact on quality of life for many men and their sexual partners. To assess the safety of tramadol orally disintegrating tablet (ODT) (Zertane) and its efficacy in prolonging intravaginal ejaculation latency time (IELT) and improving Premature Ejaculation Profile (PEP) scores. We conducted an integrated analysis of two identical 12-wk randomized double-blind, placebo-controlled phase 3 trials across 62 sites in Europe. Healthy men 18-65 yr of age with a history of lifelong PE according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision, and an IELT ≤ 120 s were included. There were 604 intent-to-treat subjects included in the analysis. Subjects were randomized to receive 1:1:1 placebo (n=200), 62 mg tramadol ODT (n=206), or 89 mg tramadol ODT (n=198). We measured overall change and fold increase in median IELT and the mean change in all four measures of the PEP. Differences across treatment groups were analyzed using Wilcoxon rank-sum tests, analysis of variance, and chi-square analyses. Tramadol ODT resulted in significant increases in median IELT compared with placebo; increases were 0.6 min (1.6 fold), 1.2 min (2.4 fold), and 1.5 min (2.5 fold) for placebo, 62 mg tramadol ODT, and 89 mg tramadol ODT, respectively (p<0.001 for all comparisons). Men saw significantly greater improvement in all four measures of the PEP in both doses compared with placebo (p<0.05 for all comparisons). Tramadol ODT was well tolerated; study discontinuation occurred in 0%, 1.0%, and 1.6% of subjects in placebo, 62 mg, and 89 mg tramadol ODT groups, respectively. Limitations include study inclusion for men with IELT up to 120 s. On-demand 62mg tramadol ODT is an effective treatment for PE in a low and safe therapeutic dose and provides a new option for managing mild to severe PE.

Bar-Or D ，Salottolo KM ，Orlando A ，Winkler JV ，Tramadol ODT Study Group ... -  《-》

Tramadol HCL has promise in on-demand use to treat premature ejaculation.

Salem EA ，Wilson SK ，Bissada NK ，Delk JR ，Hellstrom WJ ，Cleves MA ... -  《Journal of Sexual Medicine》

Treatment of premature ejaculation with paroxetine hydrochloride as needed: 2 single-blind placebo controlled crossover studies.

We evaluate the efficacy of paroxetine hydrochloride as needed for the treatment of premature ejaculation. Study 1 comprised 26 potent men with a mean age of 39.5 years with premature ejaculation who were randomized 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 randomized 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. 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. Paroxetine appears to be superior to placebo in the pharmacological treatment of premature ejaculation when administered on a chronic or as needed basis.

McMahon CG ，Touma K 《JOURNAL OF UROLOGY》