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

NCT07113145 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2025-08-08

No results posted yet for this study

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.

Conditions

  • Premature (Early) Ejaculation

Interventions

DRUG

Oral intake of medication

● Group A: Received Citalopram hydrobromide, starting with 10 mg once daily for 1 week, followed by 20 mg once daily for 10 weeks, and 10 mg daily during the final week (tapered).

DRUG

Oral intake of medication

● Group B: Received Silodosin 4mg, administered orally once daily.

DRUG

Oral intake of medication

● Group C: Received Dapoxetine hydrochloride 30 mg, taken 2 hours before intercourse, on-demand, minimum of 8 times/month for 3 months.

DRUG

Oral intake of medication

● Group D: Received Dapoxetine hydrochloride 30 mg, administered daily.

Sponsors & Collaborators

  • Beni-Suef University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-01-01
Completion
2025-03-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07113145 on ClinicalTrials.gov