A Phase 2/3 interventional study of sildosin 4mg and dapoxetine 60mg in Premature (Early) Ejaculation, sponsored by Benha University. Completed at 1 site in Egypt. Open to male participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-23.
Sponsored by Benha University · Phase 2/3, Interventional, and Treatment
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.
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.
Exclusion Criteria:
sildosin 4mg
Drug: sildosin 4mg
dapoxetine 60mg
Drug: dapoxetine 60mg
ondemand sildosin 4mg
ondemand dapoxetine 60mg
Intravaginal ejaculatory Latency time
changes in latency time
Time frame: 2 months
side effects
any side effects were recorded
Time frame: 2 months
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Plan to share: Yes — it will be shared upon request
Supporting information: Study protocol
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Benha University