Comparative Evaluation of Safety and Efficacy of Dapoxetine, Silodosin, and Citalopram in the Management of Premature Ejaculation: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- ● 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •Age ≥ 20 years.
- •In a stable, monogamous, heterosexual relationship for at least 3 months.
- •Signed informed consent indicating willingness to participate.
排除标准
- •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.
研究组 & 干预措施
Received Citalopram, starting with 10 mg once daily for 1 week, followed by 20 for 10 weeks
干预措施: Oral intake of medication (Drug)
Received Silodosin 4mg, administered orally once daily.
干预措施: Oral intake of medication (Drug)
Received Dapoxetine 30 mg, taken 2 hours before intercourse, on-demand, min 8/ month for 3 mon
干预措施: Oral intake of medication (Drug)
Received Dapoxetine hydrochloride 30 mg, administered daily.
干预措施: Oral intake of medication (Drug)
结局指标
主要结局
● 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
时间窗: 3 months
次要结局
- ● 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(3 months)
研究者
Mahmoud Abdallah
lecturer of urology
Beni-Suef University