Not Yet RecruitingNot Applicable

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

Turkey (Türkiye)250 participantsStarted 2025-10-01

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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). In a stable sexual relationship with a partner for at least 6 months. Willing to provide written informed consent and comply with study procedures. Exclusion Criteria: * Presence of erectile dysfunction (diagnosed via International Index of Erectile Function score \< 21). Severe psychiatric disorders (e.g., major depression, bipolar disorder) or neurological conditions (e.g., multiple sclerosis, Parkinson's disease). Current use of selective serotonin reuptake inhibitors (SSRIs) or other psychotropic medications. History of alcohol or substance dependence. Known contraindications to dapoxetine (e.g., hepatic impairment) or acupuncture (e.g., bleeding disorders). Previous pelvic floor surgery or trauma affecting pelvic floor muscles.

What they're measuring

Intravaginal Ejaculation Latency Time (IELT):

Timeframe: Time points: Baseline, Week 4, Week 8, Week 12, and Follow-up (Week 16

Trial details

NCT IDNCT07067970

SponsorMedipol University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-01

Contact for this trial

ALi İhsan Memmi

+90 5379220997 alimemmi@gmail.com