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

Launched by MEDIPOL UNIVERSITY · Jul 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying different treatments for premature ejaculation (PE), a common condition where ejaculation happens too quickly during sex, often within one minute, causing stress or relationship problems. The study will compare the effects and safety of a medication called dapoxetine, Kegel exercises (which strengthen pelvic muscles), and acupuncture, along with their placebo or fake treatments, to see which works best to help men last longer during intercourse.

Men between 18 and 50 years old who have PE and have been in a stable sexual relationship for at least six months may be eligible to join. Participants will be randomly assigned to one of five groups and follow their assigned treatment for 12 weeks, with a 4-week follow-up afterward. The main goal is to see if these treatments increase the time before ejaculation. Throughout the study, participants will also share how PE affects their quality of life and report any side effects. Men with certain health issues, such as erectile dysfunction, serious mental health problems, or who are already taking specific medications, will not be able to join. If you qualify, you can expect to receive one of the treatments or a placebo under careful medical supervision while tracking your progress.

Gender

MALE

Eligibility criteria

• 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.