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