ClinicalTrials.gg
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

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Mar 2024, registered Jul 2025).
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

In context

Premature Birth

2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.

This study's enrollment of 95 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
05

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

  • ondemand dapoxetine 60mg

06

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

07

Study locations

1 site
  • Benha faculty of medicine, urology department
    Banhā, Qalyubia Governorate 13511, Egypt
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

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

Supporting information: Study protocol

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2024 to primary completion in Mar 2024, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 3, 2025
First posted
Jul 23, 2025
StartActual
Mar 1, 2024
Primary completionActual
Mar 1, 2024
CompletionActual
Apr 1, 2025
Last update
Jul 23, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Not currently enrolling

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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