INTRODUCTION:Premature ejaculation (PE) is a worldwide problem without an approved treatment. Selective serotonin reuptake inhibitors (SSRIs) are widely used "off label" as pharmacotherapeutic agents in the treatment of PE. AIM: This study investigates Tramadol efficacy for on-demand treatment of PE. MAIN OUTCOMES MEASURES: Intravaginal ejaculation latency time (IELT) was used as an objective tool to assess the efficacy of the investigated treatments. MATERIALS AND METHODS: Single-blind, placebo-controlled, crossover, stopwatch monitored two-period study was conducted, on 60 patients with lifelong PE. PE was defined as IELT of <2 minutes in 80% of intercourse episodes. A total of 25 mg of Tramadol hydrochloride was given to one group (30) prior to intercourse and placebo was supplied for the other group (30) for 8 weeks. Drugs were taken 1-2 hours before sexual activity and sexual intercourse was required at least once per week. After the initial treatment period, the two groups took the alternate medication for another 2 months. The two 8-week treatment periods were separated by 1 week washout period. IELT was timed by a stopwatch at each intercourse and was reported by patients or partners. RESULTS: The baseline (mean +/- SD) IELT for patients before treatment was 1.17 +/- 0.39 minutes. At the end of the treatment period utilizing the active drug, the mean IELT was increased significantly in patients on Tramadol treatment to 7.37 +/- 2.53 minutes. The same patients on placebo medication had mean IELT of only 2.01 +/- 0.71 minutes. Patients uniformly reported satisfaction with their resulting control over ejaculation. CONCLUSIONS:Tramadol, a drug with a proven safety record as an anti-inflammatory agent, shows promise as a drug for treating rapid ejaculation.
RCT Entities:
INTRODUCTION: Premature ejaculation (PE) is a worldwide problem without an approved treatment. Selective serotonin reuptake inhibitors (SSRIs) are widely used "off label" as pharmacotherapeutic agents in the treatment of PE. AIM: This study investigates Tramadol efficacy for on-demand treatment of PE. MAIN OUTCOMES MEASURES: Intravaginal ejaculation latency time (IELT) was used as an objective tool to assess the efficacy of the investigated treatments. MATERIALS AND METHODS: Single-blind, placebo-controlled, crossover, stopwatch monitored two-period study was conducted, on 60 patients with lifelong PE. PE was defined as IELT of <2 minutes in 80% of intercourse episodes. A total of 25 mg of Tramadol hydrochloride was given to one group (30) prior to intercourse and placebo was supplied for the other group (30) for 8 weeks. Drugs were taken 1-2 hours before sexual activity and sexual intercourse was required at least once per week. After the initial treatment period, the two groups took the alternate medication for another 2 months. The two 8-week treatment periods were separated by 1 week washout period. IELT was timed by a stopwatch at each intercourse and was reported by patients or partners. RESULTS: The baseline (mean +/- SD) IELT for patients before treatment was 1.17 +/- 0.39 minutes. At the end of the treatment period utilizing the active drug, the mean IELT was increased significantly in patients on Tramadol treatment to 7.37 +/- 2.53 minutes. The same patients on placebo medication had mean IELT of only 2.01 +/- 0.71 minutes. Patients uniformly reported satisfaction with their resulting control over ejaculation. CONCLUSIONS:Tramadol, a drug with a proven safety record as an anti-inflammatory agent, shows promise as a drug for treating rapid ejaculation.
Authors: Michael K Brawer; Danil V Makarov; Alan W Partin; Claus G Roehrborn; J Curtis Nickel; Michael B Chancellor; Dean G Assimos; Ellen Shapiro; Jacob Rajfer Journal: Rev Urol Date: 2007
Authors: Michael D Staudt; Cleusa V R de Oliveira; Michael N Lehman; Kevin E McKenna; Lique M Coolen Journal: J Sex Med Date: 2011-01-14 Impact factor: 3.802