Comparison of the Efficacy and Safety of Dapoxetine, Kegel Exercises, and Acupuncture in the Treatment of Premature Ejaculation: A Randomized, Double-Blind, Placebo-Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-60
SponsorMedipol University

About this trial

This study aims to compare the efficacy and safety of dapoxetine, Kegel exercises, acupuncture, and their placebo controls in the treatment of premature ejaculation (PE). PE is a common male sexual dysfunction characterized by ejaculation occurring within one minute of vaginal penetration, causing distress or interpersonal difficulties (Althof et al., 2014). A total of 250 male participants will be randomized into five groups (dapoxetine, placebo, Kegel exercises, acupuncture, sham acupuncture) for a 12-week treatment period followed by a 4-week follow-up. The primary outcome is the increase in intravaginal ejaculation latency time (IELT), with secondary outcomes including the Premature Ejaculation Diagnostic Tool (PEDT) score, Sexual Quality of Life-Male (SQoL-M) score, and adverse effects.

Eligibility criteria

Qualifiers

Male, aged 18-50 years. Diagnosed with lifelong or acquired PE per ISSM criteria (IELT < 2 minutes, lack of ejaculatory control, and associated distress or interpersonal difficulties).

Disqualifiers

Presence of erectile dysfunction (diagnosed via International Index of Erectile Function score < 21).

Trial design

Treatments tested in this trial

  • serotonin reuptake inhibitor (SSRI)
  • Placebo
  • Acupuncture
  • Sham
  • Exercise

Treatment groups

250 Participants
are divided into 5 treatment groups

Sponsors and collaborators