Effectiveness and Tolerability of the On-demand Use of Combined Dapoxetine With Tadalafil and Combined Dapoxetine With Lidocaine 5% Spray in Treatment of Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Alone.
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Intravaginal ejaculatory latency time (IELT)
研究概览
简要总结
Therefore, this study will aim to assess the effectiveness and tolerability of the on-demand use of combined dapoxetine with tadalafil and combined dapoxetine with lidocaine 5% spray in treatment of patients with lifelong premature ejaculation and non-responding to dapoxetine alone.
详细描述
This study will be carried out on 60 patients with lifelong premature ejaculation and non-responding to dapoxetine alone.
All patients will be equally divided into 2 groups (30 patients each). Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse. Group 1 was given on-demand 30 mg dapoxetine 1 h before intercourse and apply lidocaine 5% spray on the glans penis 10 minutes the wash before intercourse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
All patients will be equally divided into 2 groups (30 patients each).Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse. Group 1 was given on-demand 30 mg dapoxetine 1 h before intercourse and apply lidocaine 5% spray on the glans penis 10 minutes the wash before intercourse.
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •lifelong premature ejaculation and non-responding to dapoxetine alone.
排除标准
- •diabetes mellitus,
- •chronic prostatitis,
- •Advanced renal or hepatic diseases
- •neurological diseases
- •C.N.S. medications
研究组 & 干预措施
Patients with lifelong premature ejaculation and non-responding to dapoxetine alone
Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse.
干预措施: Tadalafil and Combined Dapoxietine (Drug)
Patients with Lifelong Premature Ejaculation and Non-responding to Dapoxetine Alone.
Group 2 was given on-demand 30 mg dapoxetine 1 h before intercourse and apply lidocaine 5% spray on the glans penis 10 minutes the wash before intercourse.
干预措施: Dapoxietine and Combined Lidocaine 5% Spray (Drug)
结局指标
主要结局
Intravaginal ejaculatory latency time (IELT)
时间窗: 0-8 weeks
Arabic Index of Premature Ejaculation (AIPE)
时间窗: 0-8 week
次要结局
未报告次要终点
研究者
Mohammed Abu El-Hamd
Assistant Professor of Dermatology, Venereology and Andrology Department, Faculty of Medicine, Sohag University, Egypt.
Sohag University