Overview

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

Status:
NOT_YET_RECRUITING

Trial end date:
2026-12-01

Target enrollment:

Participant gender:

Summary

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.

Phase:

Details

Lead Sponsor:

Medipol University

Treatments:

Acupuncture Therapy
Exercise
salicylhydroxamic acid
Selective Serotonin Reuptake Inhibitors