NCT07081659

On-demand Silodosin 4mg vs Dapoxetine 60mg in Treatment of Primary Premature Ejaculation

On-demand Silodosin 4mg vs Dapoxetine 60mg in the Treatment of Primary Premature Ejaculation

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: Male
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Both Silodosin 4 mg and Dapoxetine 60 mg significantly improved IELT and sexual function scores in primary PE patients. However, Silodosin exhibited a more favorable tolerability profile with fewer side effects, making it a safer, clinically effective alternative.

Detailed description

Dapoxetine 60 mg, the initial FDA-approved on-demand treatment for PE, which is a selective serotonin reuptake inhibitor (SSRI) . However, Silodosin 4 mg, an α1-adrenoceptor antagonist, has emerged as a promising alternative, particularly for patients dissatisfied with Dapoxetine . This investigation is designed to evaluate the efficacy and tolerability of Silodosin 4mg and Dapoxetine 60mg in the treatment of primary premature ejaculation.

Conditions

• Premature (Early) Ejaculation

Interventions

Type	Name	Description
DRUG	sildosin 4mg	ondemand sildosin 4mg
DRUG	dapoxetine 60mg	ondemand dapoxetine 60mg

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-03-01
• Completion: 2025-04-01
• First posted: 2025-07-23
• Last updated: 2025-07-23

Locations

1 site across 1 country: Egypt