Multicenter Study of the Efficacy and Safety of Dapoxetine Combined With Tadalafil in Men With Premature Ejaculation and Concomitant Erectile Dysfunction
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 150
- 主要终点
- The change of Premature Ejaculation Profile (PEP) at week 8
研究概览
简要总结
Premature ejaculation (PE) is a common disease in the andrology clinic. Currently, the effectiveness and outcome differences of drug treatment still need to be studied and demonstrated. Premature ejaculation concurrent with erectile dysfunction (ED) is common in outpatient clinics. The preferred treatment plan for these patients still needs to be further studied and explored, and the difference in the efficacy of different treatment regiments remain to be evaluated.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •PE concurrent with ED: the IELT is less than 3 minutes, the PEDT score is ≥11 points, and 5≤IIEF-5≤21 points.
- •18-60 years old, outpatient or physical examination population, with regular sex partners and regular sex life;
- •Having the data below,and willing to participate in the trial（1）Demographic information: age, gender, nationality, birthplace, etc;(2) Physical examination data: height, weight, abdominal circumference, blood pressure, heart rate, etc ;(3) Medical history data: history of present illness, past medical history, family history, etc;(4) Scale evaluation: Premature Ejaculation Diagnostic Tool (PEDT), Premature Ejaculation Profile (PEP), International Erectile Function Score-5(IIEF-5), Erectile Hardness Grading Score (EHGS), Clinical Global Impression of Change (GICC);
排除标准
- •Age <18 years or> 60 years;
- •There is a history of acute and chronic diseases, major trauma and surgery, etc;
- •A long history of medication;
- •There is a history of unstable myocardial infarction and cerebral infarction;
- •A history of cardiogenic shock, severe heart failure, severe ventricular arrhythmia, etc;
- •There are serious diseases such as malignant tumors, chronic liver and kidney diseases, etc.
研究组 & 干预措施
tadalafil combined with dapoxetine
干预措施: Dapoxetine (Drug)
tadalafil combined with dapoxetine
干预措施: Tadalafil (Drug)
tadalafil mono group
干预措施: Tadalafil (Drug)
结局指标
主要结局
The change of Premature Ejaculation Profile (PEP) at week 8
时间窗: Baseline, Week 8
The PEP is a 4-question PRO that asks a respondent about his subjective sense of control over ejaculation, distress related to PE, interpersonal difficulty and satisfaction with sexual intercourse.
The change of International Index of Erectile Function -5(IIEF-5) at week 8
时间窗: Baseline, Week 8
次要结局
- Incidence of adverse reactions(Baseline, Week 8)
- The change of Erection Hardness Score (EHS)(Baseline, Week 8)
- Clinical Global Impression of Change (GICC)(Baseline, Week 8)
研究者
Yan-Ping Huang
Department of Urology and Andrology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai Jiao Tong University School of Medicine