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CompletedNCT07081659Updated Jul 23, 2025

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

A Phase 2/3 interventional study of sildosin 4mg and dapoxetine 60mg in Premature (Early) Ejaculation, sponsored by Benha University. Completed at 1 site in Egypt. Open to male participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-23.

Sponsored by Benha University · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
95
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
Male
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Premature (Early) Ejaculation

Keywords

  • premature ejaculation
  • sexual function
  • ejaculatory profile
  • latency time
03

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
95 participants (actual)

Study arms

  • Experimental
    group A

    sildosin 4mg

    Drug: sildosin 4mg

  • Active comparator
    group B

    dapoxetine 60mg

    Drug: dapoxetine 60mg

Interventions

  • Drugsildosin 4mg

    ondemand sildosin 4mg

  • Drugdapoxetine 60mg

    ondemand dapoxetine 60mg

05

What researchers measure

Primary outcomes

  1. Intravaginal ejaculatory Latency time

    changes in latency time

    Time frame: 2 months

Secondary outcomes

  1. side effects

    any side effects were recorded

    Time frame: 2 months

06

Study locations

1 site
  • Benha faculty of medicine, urology department
    Banhā, Qalyubia Governorate 13511, Egypt
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 1, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — it will be shared upon request

Supporting information: Study protocol

08

Registry details

Key details

Study ID
NCT07081659
Lead sponsor
Benha University
Responsible party
Hussein Shaher (assisstant professor, Benha University) — Principal investigator
First posted
Jul 23, 2025
Start date
Mar 1, 2024
Primary completion
Mar 1, 2024
Completion
Apr 1, 2025
Last update
Jul 23, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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