drugset / Trial / NCT07113145

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

NCT07113145

Phase 4 Completed 450 enrolled Beni-Suef University
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2024-06-01
Primary completion
2025-01-01
Completion
2025-03-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Citalopram Small molecule 20 mg Oral
Comparator Dapoxetine Small molecule 30 mg Oral
Comparator Silodosin Unknown 4 mg Oral

Indications