Evaluation of the Clinical Efficacy and Safety of Dapoxetine, Combined Dapoxetine With Folic Acid and Combined Dapoxetine With Vitamin B12 in Treatment of Patients With Premature Ejaculation: A Randomized Placebo-controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Arabic Index of Premature Ejaculation
研究概览
简要总结
This study will aim to assess of the clinical efficacy and safety of dapoxetine, combined dapoxetine with folic acid and combined dapoxetine with vitamin B12 in treatment of patients with premature ejaculation: A randomized placebo-controlled clinical trial.
详细描述
In a single-blind placebo-controlled clinical study, it will be carried out on 120 patients with PE.
All patients will be randomized equally divided into four groups (30 patients each).
Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse.
Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse. Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid.
Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used.
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
- •Premature ejaculation
排除标准
- •Erectile dysfunction
- •Diabetes mellitus
- •chronic prostatitis
- •Advanced renal or hepatic diseases
- •Neurological diseases
研究组 & 干预措施
Placebo
Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse.
干预措施: Multi-Vitamin Tablets (Drug)
Dapoxetine
Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse.
干预措施: Dapoxetine (Drug)
Dapoxetine and folic acid.
Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid.
干预措施: Dapoxetine and folic acid. (Drug)
Dapoxetine and vitamin B12
Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12
干预措施: Dapoxetine and vitamin B12 (Drug)
结局指标
主要结局
Arabic Index of Premature Ejaculation
时间窗: 0-6 weeks after treatment
The AIPE questionnaire includes seven questions.Response to each question will be scored on a scale from 1 to 5.
Intravaginal ejaculatory latency times
时间窗: 0-6 weeks after treatment
By using stopwatches
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