Premature (Early) EjaculationPhase 4NCT07113145
Comparative Evaluation of Safety and Efficacy of Dapoxetine, Silodosin, and Citalopram in the Management of Premature Ejaculation
A Phase 4 study testing Oral intake of medication in people with Premature (Early) Ejaculation, run by Beni-Suef University at 1 site in Egypt.
Trial summary
This randomized controlled trial evaluated the comparative effectiveness and safety of four pharmacological treatments-Citalopram 20mg, Silodosin 4 mg, Dapoxetine 30 mg on demand, and Dapoxetine 30 mg daily-in men with premature ejaculation (PE). Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Premature (Early) Ejaculation
- What is being tested?
- Oral intake of medication
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Mar 2025
- Phase
- Phase 4
- 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 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PE according to Premature Ejaculation Profile Questionnaire (PEPQ) and the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-V-TR)[12].
- Persistent or recurrent ejaculation within approximately 1 minute of vaginal penetration (confirmed by stopwatch-measured IELT ≤60 seconds at baseline)
- Inability to delay ejaculation during all or nearly all vaginal penetrations
- Negative personal consequences (distress, frustration, avoidance of sexual intimacy)
- PEPQ score ≥11.
- Age ≥ 20 years.
- In a stable, monogamous, heterosexual relationship for at least 3 months.
- Signed informed consent indicating willingness to participate.
Who cannot join
- Use of PE medications in the preceding 4 weeks.
- Use of hormonal supplements.
- Patients with erectile dysfunction diagnosed by International Index of Erectile Function.
- History of psychiatric or significant physical disorders (in either patient or partner).
- Use of antidepressants, local anesthetic sprays, intracavernosal injections, or psychotherapy within 4 weeks.
- Alcohol or substance abuse.
- Documented hypotension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Safety and Efficacy of Dapoxetine, Silodosin, and Citalopram in the Management of Premature Ejaculation: A Randomized Clinical Trial
This randomized controlled trial evaluated the comparative effectiveness and safety of four pharmacological treatments-Citalopram 20mg, Silodosin 4 mg, Dapoxetine 30 mg on demand, and Dapoxetine 30 mg daily-in men with premature ejaculation (PE). A total of 400 male patients were enrolled at Beni-Suef University Hospital and randomly assigned to one of four treatment groups (n=100). The primary outcome was the change in intravaginal ejaculatory latency time (IVELT), while secondary outcomes included ejaculatory control and sexual satisfaction, assessed using the Premature Ejaculation Profile Questionnaire (PEPQ). Side effects were also evaluated using multivariate regression analysis.
- Conditions
- Premature (Early) Ejaculation
- Being tested
- Oral intake of medication
- Keywords
- Premature ejaculation, Citalopram, Dapoxetine, Silodosin, IELT, PEPQ
- 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.
Oral intake of medicationDrug
● Group A: Received Citalopram hydrobromide, starting with 10 mg once daily for 1 week, followed by 20 mg once daily for 10 weeks, and 10 mg daily during the final week (tapered).
Oral intake of medicationDrug
● Group B: Received Silodosin 4mg, administered orally once daily.
Oral intake of medicationDrug
● Group C: Received Dapoxetine hydrochloride 30 mg, taken 2 hours before intercourse, on-demand, minimum of 8 times/month for 3 months.
Oral intake of medicationDrug
● Group D: Received Dapoxetine hydrochloride 30 mg, administered daily.
| Study group | Role | What they receive |
|---|---|---|
| Received Citalopram, starting with 10 mg once daily for 1 week, followed by 20 for 10 weeks | Active comparator | Not described Receives: Drug: Oral intake of medication |
| Received Silodosin 4mg, administered orally once daily. | Active comparator | Not described Receives: Drug: Oral intake of medication |
| Received Dapoxetine 30 mg, taken 2 hours before intercourse, on-demand, min 8/ month for 3 mon | Active comparator | Not described Receives: Drug: Oral intake of medication |
| Received Dapoxetine hydrochloride 30 mg, administered daily. | Active comparator | Not described Receives: Drug: Oral intake of medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
● Intravaginal Ejaculatory Latency Time: Minimum Value: 0 seconds Maximum Value: No fixed maximum, but usually recorded up to ~30 minutes in clinical studies Interpretation: Lower IELT values indicate worse outcomes, as they reflect shorter ejaculator
Measured: 3 months
Secondary outcomes (2)
● Premature Ejaculation Profile Questionnaire (PEPQ): Each item is scored from 1 to 5, and the total score ranges from 4 to 20. Minimum Value: 4 Maximum Value: 20 Higher scores indicate better outcomes
Measured: 3 MONTHS
Adverse events
● Side effects: Adverse effects were evaluated in terms of occurrence
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Jun 2024
- Primary completion1 Jan 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature (Early) EjaculationStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdallah, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113145
- Sponsor's protocol ID
- FMBSUREC/07052024/Ahmed
- Status last verified
- Aug 2025
- First submitted
- 31 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdellatif A, Elbatanouny A, Ragheb A, Abdelbary A, Eid A, Lotfy AM, Mahmoud O, Youssef M, Abdallah M. Comparative evaluation of safety and efficacy of dapoxetine, silodosin, and citalopram in the management of premature ejaculation: a randomized clinical trial. BMC Urol. 2025 Dec 1;25(1):298. doi: 10.1186/s12894-025-01973-7.
PubMed 41327131
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Safety and Efficacy of Dapoxetine, Silodosin, and Citalopram in the Management of Premature Ejaculation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07113145
- Acronym / sponsor ID
- FMBSUREC/07052024/Ahmed
- Conditions
- Premature (Early) Ejaculation
- Keywords
- Premature ejaculation, Citalopram, Dapoxetine, Silodosin, IELT, PEPQ
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 8 Aug 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.
This randomized controlled trial evaluated the comparative effectiveness and safety of four pharmacological treatments-Citalopram 20mg, Silodosin 4 mg, Dapoxetine 30 mg on demand, and Dapoxetine 30 mg daily-in men with premature ejaculation (PE). A total of 400 male patients were enrolled at Beni-Suef University Hospital and randomly assigned to one of four treatment groups (n=100). The primary outcome was the change in intravaginal ejaculatory latency time (IVELT), while secondary outcomes included ejaculatory control and sexual satisfaction, assessed using the Premature Ejaculation Profile Questionnaire (PEPQ). Side effects were also evaluated using multivariate regression analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Received Citalopram, starting with 10 mg once daily for 1 week, followed by 20 for 10 weeks | Active comparator | Drug: Oral intake of medication |
| Received Silodosin 4mg, administered orally once daily. | Active comparator | Drug: Oral intake of medication |
| Received Dapoxetine 30 mg, taken 2 hours before intercourse, on-demand, min 8/ month for 3 mon | Active comparator | Drug: Oral intake of medication |
| Received Dapoxetine hydrochloride 30 mg, administered daily. | Active comparator | Drug: Oral intake of medication |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of PE according to Premature Ejaculation Profile Questionnaire (PEPQ) and the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-V-TR)[12].
- Persistent or recurrent ejaculation within approximately 1 minute of vaginal penetration (confirmed by stopwatch-measured IELT ≤60 seconds at baseline)
- Inability to delay ejaculation during all or nearly all vaginal penetrations
- Negative personal consequences (distress, frustration, avoidance of sexual intimacy)
- PEPQ score ≥11.
Key exclusion criteria (7 listed)
- Use of PE medications in the preceding 4 weeks.
- Use of hormonal supplements.
- Patients with erectile dysfunction diagnosed by International Index of Erectile Function.
- History of psychiatric or significant physical disorders (in either patient or partner).
- Use of antidepressants, local anesthetic sprays, intracavernosal injections, or psychotherapy within 4 weeks.
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 |
|---|---|---|
| Oral intake of medication● Group A: Received Citalopram hydrobromide, starting with 10 mg once daily for 1 week, followed by 20 mg once daily for 10 weeks, and 10 mg daily during the final week (tapered). | Drug | Received Citalopram, starting with 10 mg once daily for 1 week, followed by 20 for 10 weeks |
| Oral intake of medication● Group B: Received Silodosin 4mg, administered orally once daily. | Drug | Received Silodosin 4mg, administered orally once daily. |
| Oral intake of medication● Group C: Received Dapoxetine hydrochloride 30 mg, taken 2 hours before intercourse, on-demand, minimum of 8 times/month for 3 months. | Drug | Received Dapoxetine 30 mg, taken 2 hours before intercourse, on-demand, min 8/ month for 3 mon |
| Oral intake of medication● Group D: Received Dapoxetine hydrochloride 30 mg, administered daily. | Drug | Received Dapoxetine hydrochloride 30 mg, administered daily. |
Primary outcome
● Intravaginal Ejaculatory Latency Time: Minimum Value: 0 seconds Maximum Value: No fixed maximum, but usually recorded up to ~30 minutes in clinical studies Interpretation: Lower IELT values indicate worse outcomes, as they reflect shorter ejaculator
Time frame: 3 months
2 secondary outcomes
● Premature Ejaculation Profile Questionnaire (PEPQ): Each item is scored from 1 to 5, and the total score ranges from 4 to 20. Minimum Value: 4 Maximum Value: 20 Higher scores indicate better outcomes
Time frame: 3 MONTHS
Adverse events
Time frame: 3 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 8 Aug 2025.
- Derived from this study: PubMed 41327131Abdellatif A, Elbatanouny A, Ragheb A, Abdelbary A, Eid A, Lotfy AM, Mahmoud O, Youssef M, Abdallah M. Comparative evaluation of safety and efficacy of dapoxetine, silodosin, and citalopram in the management of premature ejaculation: a randomized clinical trial. BMC Urol. 2025 Dec 1;25(1):298. doi: 10.1186/s12894-025-01973-7.
- Individual participant dataSharing planned: No
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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 4 study testing Oral intake of medication in people with Premature (Early) Ejaculation, run by Beni-Suef 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 8 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 8 Aug 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: Minimum Value: 0 seconds Maximum Value: No fixed maximum, but usually recorded up to ~30 minutes in clinical studies Interpretation: Lower IELT values indicate worse outcomes, as they reflect shorter ejaculator (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07113145, which also lists 1 linked publication.
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 8 Aug 2025.