On-demand Silodosin 4mg vs Dapoxetine 60mg in the Treatment of Primary Premature Ejaculation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Intravaginal ejaculatory Latency time
研究概览
简要总结
Both Silodosin 4 mg and Dapoxetine 60 mg significantly improved IELT and sexual function scores in primary PE patients. However, Silodosin exhibited a more favorable tolerability profile with fewer side effects, making it a safer, clinically effective alternative.
详细描述
Dapoxetine 60 mg, the initial FDA-approved on-demand treatment for PE, which is a selective serotonin reuptake inhibitor (SSRI) . However, Silodosin 4 mg, an α1-adrenoceptor antagonist, has emerged as a promising alternative, particularly for patients dissatisfied with Dapoxetine . This investigation is designed to evaluate the efficacy and tolerability of Silodosin 4mg and Dapoxetine 60mg in the treatment of primary premature ejaculation.
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 (Participant)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Heterosexual male
- •Sexually active
- •Aged 25 to 65 years old.
- •Primary premature ejaculation (IELT < 1 minute)
- •They had experienced PE for a minimum of 6 months
排除标准
- •Patients with a history of diabetes or
- •Uncontrolled hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg) was precluded from the study.
- •Anatomic abnormalities of the penis or genital region,
- •Erectile dysfunction,
- •Chronic prostatitis,
- •Psychological disorder
- •Patients on anti-psychotic drugs.
研究组 & 干预措施
group A
sildosin 4mg
干预措施: sildosin 4mg (Drug)
group B
dapoxetine 60mg
干预措施: dapoxetine 60mg (Drug)
结局指标
主要结局
Intravaginal ejaculatory Latency time
时间窗: 2 months
changes in latency time
次要结局
- side effects(2 months)
研究者
Hussein Shaher
assisstant professor
Benha University