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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Received Citalopram, starting with 10 mg once daily for 1 week, followed by 20 for 10 weeks | Active Comparator |
| |
| Received Silodosin 4mg, administered orally once daily. | Active Comparator |
| |
| Received Dapoxetine 30 mg, taken 2 hours before intercourse, on-demand, min 8/ month for 3 mon | Active Comparator |
| |
| Received Dapoxetine hydrochloride 30 mg, administered daily. | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral intake of medication | Drug | ● 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). |
| Measure | Description | Time Frame |
|---|---|---|
| ● 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| ● 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 | 3 MONTHS | |
| Adverse events | ● Side effects: Adverse effects were evaluated in terms of occurrence |
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Inclusion Criteria:
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.
Exclusion Criteria:
Males
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni-Suef university | Banī Suwayf | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41327131 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2024 |
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| Oral intake of medication | Drug | ● Group B: Received Silodosin 4mg, administered orally once daily. |
|
| Oral intake of medication | Drug | ● 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 medication | Drug | ● Group D: Received Dapoxetine hydrochloride 30 mg, administered daily. |
|
| 3 months |
| Aug 6, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D061686 | Premature Ejaculation |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000097910 | Ejaculatory Dysfunction |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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