CompletedPhase 4

Comparative Evaluation of Safety and Efficacy of Dapoxetine, Silodosin, and Citalopram in the Management of Premature Ejaculation

Egypt450 participantsStarted 2024-06-01

Plain-language summary

This randomized controlled trial evaluated the comparative effectiveness and safety of four pharmacological treatments-Citalopram 20mg, Silodosin 4 mg, Dapoxetine 30 mg on demand, and Dapoxetine 30 mg daily-in men with premature ejaculation (PE). A total of 400 male patients were enrolled at Beni-Suef University Hospital and randomly assigned to one of four treatment groups (n=100). The primary outcome was the change in intravaginal ejaculatory latency time (IVELT), while secondary outcomes included ejaculatory control and sexual satisfaction, assessed using the Premature Ejaculation Profile Questionnaire (PEPQ). Side effects were also evaluated using multivariate regression analysis.

Who can participate

Age range20 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: * Diagnosis of PE according to Premature Ejaculation Profile Questionnaire (PEPQ) and the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-V-TR)\[12\]. * Persistent or recurrent ejaculation within approximately 1 minute of vaginal penetration (confirmed by stopwatch-measured IELT ≤60 seconds at baseline) * Inability to delay ejaculation during all or nearly all vaginal penetrations * Negative personal consequences (distress, frustration, avoidance of sexual intimacy) * PEPQ score ≥11. * Age ≥ 20 years. * In a stable, monogamous, heterosexual relationship for at least 3 months. * Signed informed consent indicating willingness to participate. Exclusion Criteria: * Use of PE medications in the preceding 4 weeks. * Use of hormonal supplements. * Patients with erectile dysfunction diagnosed by International Index of Erectile Function. * History of psychiatric or significant physical disorders (in either patient or partner). * Use of antidepressants, local anesthetic sprays, intracavernosal injections, or psychotherapy within 4 weeks. * Alcohol or substance abuse. * Documented hypotension.

What they're measuring

● Intravaginal Ejaculatory Latency Time: Minimum Value: 0 seconds Maximum Value: No fixed maximum, but usually recorded up to ~30 minutes in clinical studies Interpretation: Lower IELT values indicate worse outcomes, as they reflect shorter ejaculator

Timeframe: 3 months

Trial details

NCT IDNCT07113145

SponsorBeni-Suef University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-01