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Keywords:

  • Design;
  • Methodology of Clinical Trials;
  • Causes and Treatment of Ejaculatory/Orgasmic Disorders;
  • Premature Ejaculation

ABSTRACT

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. Salem EA, Wilson SK, Bissada NK, Delk JR II, Hellstrom WJ, and Cleves MA. Tramadol HCL has promise in on-demand use to treat premature ejaculation. J Sex Med 2008;5:188–193.