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NCT Number: NCT07113145

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

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.

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Key information

Conditions

Premature (Early) Ejaculation Ejaculatory Dysfunction Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Premature Ejaculation Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Beni-Suef university

Banī Suwayf, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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

    Time frame: 3 months

Secondary outcomes

  1. ● 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

    Time frame: 3 MONTHS

  2. Adverse events

    Time frame: 3 months

    ● Side effects: Adverse effects were evaluated in terms of occurrence

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Comparative Evaluation of Safety and Efficacy of Dapoxetine, Silodosin, and Citalopram in the Management of Premature Ejaculation: A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 8, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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