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

NCT07113145 | Completed Phase 4

• 1 other identifier: FMBSUREC/07052024/Ahmed
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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

Keywords

Premature ejaculation; Citalopram; Dapoxetine; Silodosin; IELT; PEPQ

Outcome Measures

Primary Outcomes (1)

• ● 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 Outcomes (2)

• ● 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

Study Arms (4)

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

ACTIVE COMPARATOR

Drug: Oral intake of medication

Received Silodosin 4mg, administered orally once daily.

ACTIVE COMPARATOR

Drug: Oral intake of medication

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

ACTIVE COMPARATOR

Drug: Oral intake of medication

Received Dapoxetine hydrochloride 30 mg, administered daily.

ACTIVE COMPARATOR

Drug: Oral intake of medication

Interventions

Oral intake of medication 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 Citalopram, starting with 10 mg once daily for 1 week, followed by 20 for 10 weeks

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: Males
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef university

Banī Suwayf, Egypt

Location

Related Publications (1)

• Abdellatif A, Elbatanouny A, Ragheb A, Abdelbary A, Eid A, Lotfy AM, Mahmoud O, Youssef M, Abdallah M. Comparative evaluation of safety and efficacy of dapoxetine, silodosin, and citalopram in the management of premature ejaculation: a randomized clinical trial. BMC Urol. 2025 Dec 1;25(1):298. doi: 10.1186/s12894-025-01973-7.

  PMID: 41327131 DERIVED

MeSH Terms

Conditions

Premature Birth; Premature Ejaculation

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 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of urology

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 8, 2025
• Study Start: June 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)