A Prospective, Randomized, 3-arm Parallel Trial to Evaluate the Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i Treatment
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- International Index of Erectile Function-Erectile Dysfunction (IIEF-ED) Domain Score
研究概览
简要总结
Clinical effectiveness is of the finest tools to evaluate treatment success and is combined of 3 elements: treatment effectivity, side effect profile and patient compliance. Since the 3 main PDE5i's differ in their molecular structure, therapeutic profile and pharmacokinetics, it seems logical to assume that combining 2 different PDE5i's at lower dosage each may be beneficial in comparison to a single PDE5i maximal dose therapy. The aim of this study is to compare the clinical effectiveness of combination therapy (2 lower-dose PDE5i's) versus single maximal dose PDE5i therapy.
详细描述
This will be a prospective, randomized, 3-arm parallel trial on 60 males with erectile dysfunction (ED) that have never been exposed to PDE5i therapy (naïve patients) will be enrolled. In each group, every patient will receive three treatment regimes (Viagra®50mg & Cialis®10mg, Viagra®100mg, Cialis®20mg), in different sequences of administration.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ranging between 35-75 years.
- •Sexually active
- •IIEF ED domain score 22 and below
排除标准
- •Subjects with premature ejaculation as their main sexual complaint.
- •Subjects with severe cardiovascular disease
- •Subjects with Contraindications to PDE5i therapy. Namely patients receiving treatment with nitrate based medication or patients that for various reasons cannot take PDE5 inhibitors (i.e severe coronary disease, liver or renal failure, concomitant medications, etc.).
研究组 & 干预措施
Maximal dose sildenafil
4 tablets of sildenafil 100mg are given for on demand use
干预措施: Sildenafil 100 mg (Drug)
Tadalafil 20mg maximal dose
4 tablets of tadalafil 20mg are given for on demand use
干预措施: Tadalafil 20 mg (Drug)
Combination half dose
4 tablets of sildenafil 50mg and tadalafil 10mg are given for on demand use
干预措施: Combination half of maximal dose for sildenafil & tadalafil (Drug)
结局指标
主要结局
International Index of Erectile Function-Erectile Dysfunction (IIEF-ED) Domain Score
时间窗: Every visit- altogether 3 months
At each visit after use of different treatment each time
次要结局
- Erection Hardness Scale(Each visit- altogether 3 months)