A Phase 4 interventional study of Oral intake of medication and Oral intake of medication in Premature (Early) Ejaculation, sponsored by Beni-Suef University. Completed at 1 site in Egypt. Open to male participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by Beni-Suef University · Phase 4, Interventional, and Treatment
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.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 450 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Beni-Suef University is the lead sponsor of 349 studies on the registry; 125 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
PEPQ score ≥11.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Oral intake of medication
Drug: Oral intake of medication
Drug: Oral intake of medication
Drug: 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).
● Group B: Received Silodosin 4mg, administered orally once daily.
● Group C: Received Dapoxetine hydrochloride 30 mg, taken 2 hours before intercourse, on-demand, minimum of 8 times/month for 3 months.
● Group D: Received Dapoxetine hydrochloride 30 mg, administered daily.
● 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
● 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
● Side effects: Adverse effects were evaluated in terms of occurrence
Time frame: 3 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2024 to primary completion in Jan 2025, 7 months.
Of 54 non-industry phase 4 interventional studies under Premature Birth, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 60. This study's 7 months is below that.
Counting every sponsor, half of 54 studies reached it within 25 months; a quarter within 13 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.