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

NCT07081659 | Completed Phase 2

• 1 other identifier: Ms13-3-2024
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature (Early) Ejaculation

Keywords

premature ejaculation; sexual function; ejaculatory profile; latency time

Outcome Measures

Primary Outcomes (1)

• Intravaginal ejaculatory Latency time

  changes in latency time

  2 months

Secondary Outcomes (1)

• side effects

  2 months

Study Arms (2)

group A

EXPERIMENTAL

sildosin 4mg

Drug: sildosin 4mg

group B

ACTIVE COMPARATOR

dapoxetine 60mg

Drug: dapoxetine 60mg

Interventions

sildosin 4mg DRUG

ondemand sildosin 4mg

group A

dapoxetine 60mg DRUG

ondemand dapoxetine 60mg

group B

Eligibility Criteria

• Age: 25 Years - 65 Years
• Gender Eligibility Details: male patients in heterosexual relation
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha faculty of medicine, urology department

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Premature Birth; Premature Ejaculation

Interventions

dapoxetine

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant professor

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 23, 2025
• Study Start: March 1, 2024
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)