NCT07113145

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

Comparative Evaluation of Safety and Efficacy of Dapoxetine, Silodosin, and Citalopram in the Management of Premature Ejaculation: A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: Male
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Premature (Early) Ejaculation

Interventions

Type	Name	Description
DRUG	Oral intake of medication	● Group A: Received Citalopram hydrobromide, starting with 10 mg once daily for 1 week, followed by 20 mg once daily for 10 weeks, and 10 mg daily during the final week (tapered).
DRUG	Oral intake of medication	● Group B: Received Silodosin 4mg, administered orally once daily.
DRUG	Oral intake of medication	● Group C: Received Dapoxetine hydrochloride 30 mg, taken 2 hours before intercourse, on-demand, minimum of 8 times/month for 3 months.
DRUG	Oral intake of medication	● Group D: Received Dapoxetine hydrochloride 30 mg, administered daily.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-01-01
• Completion: 2025-03-01
• First posted: 2025-08-08
• Last updated: 2025-08-08

Locations

1 site across 1 country: Egypt