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

July 15, 2025 updated by: Hussein Shaher, Benha University

On-demand Silodosin 4mg vs Dapoxetine 60mg in the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Qalyubia
      • Banhā, Qalyubia, Egypt, 13511
        • Benha faculty of medicine, urology department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group A
sildosin 4mg
Drug: sildosin 4mg
ondemand sildosin 4mg
Active Comparator: group B
dapoxetine 60mg
Drug: dapoxetine 60mg
ondemand dapoxetine 60mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intravaginal ejaculatory Latency time
Time Frame: 2 months
changes in latency time
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
side effects
Time Frame: 2 months
any side effects were recorded
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

July 3, 2025

First Submitted That Met QC Criteria

July 15, 2025

First Posted (Actual)

July 23, 2025

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 15, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ms13-3-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

it will be shared upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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