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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
450
● 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.
Beni-Suef university
Banī Suwayf, Egypt
● 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
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