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

Not Applicable

Completed

• Conditions: Premature (Early) Ejaculation
• Interventions: Drug: Oral intake of medication

• Registration Number: NCT07113145
• Lead Sponsor: Beni-Suef University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-03-01
• Study First Submitted: 2025-07-31
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-06
• Last Update Submitted: 2025-08-06
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 450

Inclusion Criteria

• Diagnosis of PE according to Premature Ejaculation Profile Questionnaire (PEPQ) and the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-V-TR)[12].

• Persistent or recurrent ejaculation within approximately 1 minute of vaginal penetration (confirmed by stopwatch-measured IELT ≤60 seconds at baseline)

• Inability to delay ejaculation during all or nearly all vaginal penetrations

• Negative personal consequences (distress, frustration, avoidance of sexual intimacy)

• PEPQ score ≥11.

  • Age ≥ 20 years.
  • In a stable, monogamous, heterosexual relationship for at least 3 months.
  • Signed informed consent indicating willingness to participate.

Exclusion Criteria

• Use of PE medications in the preceding 4 weeks.
• Use of hormonal supplements.
• Patients with erectile dysfunction diagnosed by International Index of Erectile Function.
• History of psychiatric or significant physical disorders (in either patient or partner).
• Use of antidepressants, local anesthetic sprays, intracavernosal injections, or psychotherapy within 4 weeks.
• Alcohol or substance abuse.
• Documented hypotension.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Received Citalopram, starting with 10 mg once daily for 1 week, followed by 20 for 10 weeks	Oral intake of medication	-
Received Silodosin 4mg, administered orally once daily.	Oral intake of medication	-
Received Dapoxetine 30 mg, taken 2 hours before intercourse, on-demand, min 8/ month for 3 mon	Oral intake of medication	-
Received Dapoxetine hydrochloride 30 mg, administered daily.	Oral intake of medication	-

Primary Outcome Measures

Name	Time	Method
● Intravaginal Ejaculatory Latency Time: Minimum Value: 0 seconds Maximum Value: No fixed maximum, but usually recorded up to ~30 minutes in clinical studies Interpretation: Lower IELT values indicate worse outcomes, as they reflect shorter ejaculator	3 months

Secondary Outcome Measures

Name	Time	Method
● Premature Ejaculation Profile Questionnaire (PEPQ): Each item is scored from 1 to 5, and the total score ranges from 4 to 20. Minimum Value: 4 Maximum Value: 20 Higher scores indicate better outcomes	3 MONTHS
Adverse events	3 months	● Side effects: Adverse effects were evaluated in terms of occurrence

Trial Locations

Locations (1)

Beni-Suef university; 🇪🇬 Beni Suef, Egypt

Beni-Suef university

🇪🇬Beni Suef, Egypt