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
- 46
- 试验地点
- 1
- 主要终点
- increase of 5 points or more in the IIEF erectile function domain
研究概览
简要总结
A prospective, randomized, 3-arm parallel trial on 45 males with ED that were never exposed to PDE5i therapy (naïve patients) will be enrolled.In each group, every patient will receive three treatment regimes (Viagra®50mg & Levitra®10mg, Viagra®100mg, Levitra®20mg), in different sequences of administration in such a manner that eventually each patient will receive all regimes in a double- blinded fasion.Safety will be evaluated at pre- screening by measuring hourly vital signs (blood pressure, heart rate)for 4 consecutive hours after taking half-dose combination. Any decrease in blood pressure of 20 mmhg below baseline will exclude the subject from the study. Effcacy will be evaluated by questionnaires (IIEF, Quality of erection questionnaire, grade of erection scale, Sear, QVS and Sexual Encounter Profiles for each sexual event). Non-parametric statistical analysis of the collected data Comparing the 3 groups will be performed.
详细描述
A prospective, randomized, 3-arm parallel trial on 45 males with ED that were never exposed to PDE5i therapy (naïve patients) will be enrolled. Recruitment will be performed via advertisement or by offering newly diagnosed naïve ED patients visiting the clinic to participate in the study.
In each group, every patient will receive three treatment regimes (Viagra®50mg & Levitra®10mg, Viagra®100mg, Levitra®20mg), in different sequences of administration, as follows:
Group 1) 15 naïve patients will start with Viagra®100mg, continue with Levitra®20mg and end the study with combined Viagra®50mg & Levitra®10mg.
Group 2) 15 naïve patients will start with combined Viagra®50mg & Levitra®10mg, continue with Levitra®20mg and end the study with Viagra®100mg.
Group 3) 15 naïve patients will start with Levitra®20mg, continue with Viagra®100mg and end the study with combined Viagra®50mg & Levitra®10mg.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Relationship with the same partner for at least 3 month
- •Age ranging between 35-65 years old
- •Sexually active, (minimal frequency of one sexual encounter per 2 weeks)
- •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 in the past 6 months, including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack, symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation,
- •Subjects with Contraindications to PDE5i therapy. Namely patients receiving treatment with nitrate based medication or patients that for various reasons cannot take PDE5 inhibitors (severe hepatic diseases- cirrhosis or ALT (Alanine aminotransferase)>2x upper limit of normal), renal impairment (creatinine clearance > 30ml/min) or known hereditary degenerative retinal disorders such as retinitis pigmentosa. ,
- •Concomitant treatment with potent CYP3A4 and CYP2C9 inhibitors (e.g protease inhibitors ritonavir and saquinavir, ketoconazole, itrakonazole, miconazole, nefazodone, claritromycin, troleandomycin, erythromycin and cimetidine)
- •Subjects mentally unfit for the study.
研究组 & 干预措施
Viagra 100mg
干预措施: Sildenafil (Drug)
Levitra 20mg
干预措施: Vardenafil (Drug)
Viagra 50mg+ Levitra 10mg
干预措施: Sildenafil, Vardenafil (Drug)
Viagra 50mg+ Levitra 10mg
干预措施: Sildenafil & Vardenafil (Drug)
结局指标
主要结局
increase of 5 points or more in the IIEF erectile function domain
时间窗: 1 month
次要结局
未报告次要终点