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OpenTrials
Completed

NCT Number: NCT07081659

On-demand Silodosin 4mg vs Dapoxetine 60mg in Treatment of Primary Premature Ejaculation

Both Silodosin 4 mg and Dapoxetine 60 mg significantly improved IELT and sexual function scores in primary PE patients. However, Silodosin exhibited a more favorable tolerability profile with fewer side effects, making it a safer, clinically effective alternative.

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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

25 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Benha faculty of medicine, urology department

Banhā, Qalyubia Governorate, 13511, Egypt

About this study

Dapoxetine 60 mg, the initial FDA-approved on-demand treatment for PE, which is a selective serotonin reuptake inhibitor (SSRI) . However, Silodosin 4 mg, an α1-adrenoceptor antagonist, has emerged as a promising alternative, particularly for patients dissatisfied with Dapoxetine . This investigation is designed to evaluate the efficacy and tolerability of Silodosin 4mg and Dapoxetine 60mg in the treatment of primary premature ejaculation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Heterosexual male
  • Sexually active
  • Aged 25 to 65 years old.
  • Primary premature ejaculation (IELT < 1 minute)
  • They had experienced PE for a minimum of 6 months

Exclusion criteria

  • Patients with a history of diabetes or
  • Uncontrolled hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg) was precluded from the study.
  • Anatomic abnormalities of the penis or genital region,
  • Erectile dysfunction,
  • Chronic prostatitis,
  • Psychological disorder
  • Patients on anti-psychotic drugs.

Treatment and study plan

sildosin 4mg

Drug

ondemand sildosin 4mg

dapoxetine 60mg

Drug

ondemand dapoxetine 60mg

Primary outcomes

  1. Intravaginal ejaculatory Latency time

    Time frame: 2 months

    changes in latency time

Secondary outcomes

  1. side effects

    Time frame: 2 months

    any side effects were recorded

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

On-demand Silodosin 4mg vs Dapoxetine 60mg in the Treatment of Primary Premature Ejaculation

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 23, 2025
Registry last updated
Jul 23, 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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