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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
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07081659
Enrollment
95
Registered
2025-07-23
Start date
2024-03-01
Completion date
2025-04-01
Last updated
2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature (Early) Ejaculation

Keywords

premature ejaculation, sexual function, ejaculatory profile, latency time

Brief 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.

Interventions

DRUGsildosin 4mg

ondemand sildosin 4mg

DRUGdapoxetine 60mg

ondemand dapoxetine 60mg

Sponsors

Benha University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
25 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Heterosexual male * Sexually active * Aged 25 to 65 years old. * Primary premature ejaculation (IELT \< 1 minute) * They had experienced PE for a minimum of 6 months

Exclusion criteria

* Patients with a history of diabetes or * Uncontrolled hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg) was precluded from the study. * Anatomic abnormalities of the penis or genital region, * Erectile dysfunction, * Chronic prostatitis, * Psychological disorder * Patients on anti-psychotic drugs.

Design outcomes

Primary

MeasureTime frameDescription
Intravaginal ejaculatory Latency time2 monthschanges in latency time

Secondary

MeasureTime frameDescription
side effects2 monthsany side effects were recorded

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026