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

NANot yet recruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

October 1, 2026

Study Completion Date

December 1, 2026

Conditions
Premature Ejaculation
Interventions
DRUG

serotonin reuptake inhibitor (SSRI)

"Dapoxetine Group~Dosage: 30 mg dapoxetine, taken orally 1-3 hours before anticipated sexual activity, with a maximum of 3 doses per week.~Administration: Provided in blister packs to ensure compliance. Reference: McMahon et al., 2011."

DRUG

Placebo

"Dosage: Placebo tablets identical in appearance and taste to dapoxetine, administered on the same schedule (1-3 hours before sexual activity, maximum 3 doses per week).~Administration: Provided in identical blister packs."

OTHER

Acupuncture

"Protocol: Two 30-minute acupuncture sessions per week, targeting standardized points (e.g., CV4, SP6, ST36) known to influence sexual function and autonomic nervous system regulation.~Administration: Performed by licensed acupuncturists following a standardized protocol.~Reference: Sunay et al., 2011."

OTHER

Sham

"Sham Acupuncture Group:Protocol: Two 30-minute sessions per week using superficial needle insertion at non-active points to minimize therapeutic effects while maintaining the placebo effect.~Administration: Performed by licensed acupuncturists to ensure consistency with the active acupuncture group"

BEHAVIORAL

Exercise

"Kegel Exercises Group:Protocol: Participants will perform pelvic floor muscle exercises consisting of three sets of 10-15 contractions daily, each held for 5-10 seconds followed by relaxation.~Training: Participants will receive initial training from a licensed physiotherapist, with weekly follow-up sessions to ensure proper technique and adherence.~Reference: Pastore et al., 2014."

Trial Locations (1)

Unknown

Medipol, Istanbul

All Listed Sponsors
lead

Medipol University

OTHER

NCT07067970 - 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 | Biotech Hunter | Biotech Hunter