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

NCT ID: NCT07113145

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-03-01

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.

Conditions

Premature (Early) Ejaculation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Received Citalopram, starting with 10 mg once daily for 1 week, followed by 20 for 10 weeks

Group Type: ACTIVE_COMPARATOR

Oral intake of medication

Intervention Type: DRUG

● 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).

Received Silodosin 4mg, administered orally once daily.

Group Type: ACTIVE_COMPARATOR

Oral intake of medication

Intervention Type: DRUG

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

Received Dapoxetine 30 mg, taken 2 hours before intercourse, on-demand, min 8/ month for 3 mon

Group Type: ACTIVE_COMPARATOR

Oral intake of medication

Intervention Type: DRUG

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

Received Dapoxetine hydrochloride 30 mg, administered daily.

Group Type: ACTIVE_COMPARATOR

Oral intake of medication

Intervention Type: DRUG

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

Interventions

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).

Intervention Type: DRUG

Oral intake of medication

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

Intervention Type: 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.

Intervention Type: DRUG

Oral intake of medication

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Abdallah

lecturer of urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beni-Suef university

Banī Suwayf, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FMBSUREC/07052024/Ahmed

Identifier Type: -

Identifier Source: org_study_id