Safety and efficacy of tramadol hydrochloride on treatment of premature ejaculation

Asian J Androl. 2013 Jan;15(1):138-42. doi: 10.1038/aja.2012.96. Epub 2012 Oct 29.

Abstract

Premature ejaculation (PE) is the most common sexual disorder. It affects 20%-30% of adult men; the aetiology of this condition has not yet been elucidated. The aim of this study is to evaluate the efficacy, safety, tolerability, undesirable effects and improved satisfaction with sexual intercourse with tramadol hydrochloride at different dosages for the treatment of PE. A total of 300 patients who presented with lifelong (primary) PE were included in this study. The study was performed for 28 weeks, in which placebo (starch tablet) was given for 4 weeks, and active ingredient (tramadol hydrochloride) was administered at different therapeutic dosages for 24 weeks. Patients were divided into three equal groups, each consisting of 100 patients. The first group (A) was given tramadol hydrochloride capsule 25 mg. The second group (B) was given tramadol hydrochloride capsule 50 mg. The third group (C) was given tramadol hydrochloride capsule 100 mg. All of the 300 participants included completed the study voluntarily. The age of the patients varied from 25 to 50 years. After the treatment period, the recorded data were collected for each group and analysed. The results showed a highly significant increase in the mean intravaginal ejaculatory latency time (IELT) in all groups compared to baseline data (P<0.0001). We concluded that using tramadol hydrochloride at different doses on demand for the treatment of PE is effective, safe and tolerable, with minimal undesirable effects, and approval for this indication should be sought.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Coitus
  • Female
  • Humans
  • Male
  • Middle Aged
  • Patient Satisfaction
  • Premature Ejaculation / drug therapy*
  • Sexual Dysfunction, Physiological / drug therapy
  • Tramadol / administration & dosage*
  • Tramadol / adverse effects
  • Tramadol / therapeutic use
  • Treatment Outcome

Substances

  • Tramadol