Premature (Early) EjaculationPhase 2/3NCT07081659
On-demand Silodosin 4mg vs Dapoxetine 60mg in Treatment of Primary Premature Ejaculation
A Phase 2/3 study testing sildosin 4mg and dapoxetine 60mg in people with Premature (Early) Ejaculation, run by Benha University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 25 to 65 years, men only
- Conditions the study is for
- Premature (Early) Ejaculation
- What is being tested?
- sildosin 4mg and dapoxetine 60mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Apr 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Benha faculty of medicine, urology department
Banhā, Qalyubia Governorate, 13511
About this study
Official title: 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.
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.
- Conditions
- Premature (Early) Ejaculation
- Being tested
- sildosin 4mg, dapoxetine 60mg
- Keywords
- premature ejaculation, sexual function, ejaculatory profile, latency time
- Medical subject headings
- Premature Birth, Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sildosin 4mgDrug
ondemand sildosin 4mg
dapoxetine 60mgDrug
ondemand dapoxetine 60mg
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | sildosin 4mg Receives: Drug: sildosin 4mg |
| group B | Active comparator | dapoxetine 60mg Receives: Drug: dapoxetine 60mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravaginal ejaculatory Latency time
changes in latency time
Measured: 2 months
Secondary outcomes (1)
side effects
any side effects were recorded
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Mar 2024
- Primary completion1 Mar 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature (Early) EjaculationStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Shaher, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081659
- Sponsor's protocol ID
- Ms13-3-2024
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: it will be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On-demand Silodosin 4mg vs Dapoxetine 60mg in the Treatment of Primary Premature Ejaculation
- ClinicalTrials.gov ID
- NCT07081659
- Acronym / sponsor ID
- Ms13-3-2024
- Conditions
- Premature (Early) Ejaculation
- Keywords
- premature ejaculation, sexual function, ejaculatory profile, latency time
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: sildosin 4mgsildosin 4mg |
| group B | Active comparator | Drug: dapoxetine 60mgdapoxetine 60mg |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sildosin 4mgondemand sildosin 4mg | Drug | group A |
| dapoxetine 60mgondemand dapoxetine 60mg | Drug | group B |
Primary outcome
Intravaginal ejaculatory Latency time
Time frame: 2 months
changes in latency time
1 secondary outcome
side effects
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: Yes. it will be shared upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing sildosin 4mg and dapoxetine 60mg in people with Premature (Early) Ejaculation, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intravaginal ejaculatory Latency time (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.