NCT00301262已完成4 期
A Multi-Center, Parallel Group, Flexible Dose Trial With A Double-Blind, Randomized, Placebo-Controlled Phase Followed By An Open-Label Phase To Assess The Impact Of Viagra On The Sexual Satisfaction Of Men With Mild Erectile Dysfunction
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.27 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2005年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 183
- 试验地点
- 27
- 主要终点
- Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8)
研究概览
简要总结
Men's quality of life (QoL) is potentially affected by mild erectile dysfunction (ED) to the same extent as it is by moderate and severe ED. This study will provide controlled clinical data measuring efficacy, QoL parameters and satisfaction changes in men with mild ED treated with Viagra versus those treated with a placebo. With an open-label extension, this study will also provide all study subjects the opportunity to receive the active drug treatment for 6 weeks.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men above age of majority
- •Mild erectile dysfunction (IIEF-EF 22-25) and sexual dissatisfaction (IIEF-OS 7 or less)
排除标准
- •Use of more than 4 doses of any PDE5 inhibitor in the past 12 weeks and use of any PDE5 inhibitor in the past 4 weeks
- •Subjects currently taking any other commercially available drug or non-drug treatment for ED
结局指标
主要结局
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8)
时间窗: Week 8
adjusted mean : Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).
次要结局
- Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score(Week 8)
- Patient Reported Erectile Function Assessment (PREFA) Total Score(Week 8, Week 14)
- Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction(Week 8)
- International Index of Erectile Function (IIEF) Domain Scores- Erectile Function(Week 8, Week 14)
- International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction(Week 8, Week 14)
- Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score(Week 8)
- Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)(Week 8, Week 14)
- Percentage of Occasions of Successful Intercourse (Event Log)(Week 8 to Week 14)
- Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)(Baseline to Week 8)
- International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction(Week 8, Week 14)
- Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)(Week 8, Week 14)
- Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function(Week 8)
- Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction(Week 8)
- International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire(Week 8, Week 14)
- Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score(Week 8)
- Erectile Distress Scale (EDS) Total Score(Week 8, Week 14)
- Change From Baseline to Week 8 in Analog Scales- Reliability(baseline to Week 8)
- Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0(Baseline to <Week 8 and Week 8 to <=Week 14)
- Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3(Baseline to <Week 8 and Week 8 to <=Week 14)
- Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index(Week 8, Week 14)
- Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function(Week 8)
- Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire(Week 8)
- Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)(Week 8, Week 14)
- Change From Baseline to Week 8 in Analog Scales- Maintenance(baseline to Week 8)
- Change From Baseline to Week 8 in Analog Scales- General Sexual Performance(baseline to week 8)
- Analog Scales- Reliability(Week 8, Week 14)
- Shift in Responder Rate From Week 8 to Week 14 for GEQ2(Week 8 to Week 14)
- International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function(Week 8, Week 14)
- Quality of Erection Questionnaire (QEQ) Total Score(Week 8, Week 14)
- Change From Baseline to Week 8 in Analog Scales- Firmness(baseline to Week 8)
- Analog Scales- Maintenance(Week 8, Week 14)
- Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1(Week 8 to Week 14)
- Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1(Baseline to <= Week 14)
- Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2(Baseline to <Week 8 and Week 8 to <=Week 14)
- Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4(Baseline to <Week 8 and Week 8 to <=Week 14)
- Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2(Baseline to <Week 8 and Week 8 to <=Week 14)
- Percentage of Occasions of Ejaculation and/or Orgasm Event Log(Week 8 to Week 14)
- Analog Scales- Firmness(Week 8, Week 14)
- Analog Scales- General Sexual Performance(Week 8, Week 14)
- Shift in Responder Rate From Week 8 to Week 14 for GEQ3(Week 8 to Week 14)
- Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4(Baseline to <Week 8 and Week 8 to <=Week 14)
- Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1(Baseline to <Week 8 and Week 8 to <=Week 14)
- Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0(Baseline to <Week 8 and Week 8 to <=Week 14)
- Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3(Baseline to <Week 8 and Week 8 to <=Week 14)
- Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4(Baseline to <Week 8 and Week 8 to <=Week 14)
- Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4(Baseline to <Week 8 and Week 8 to <=Week 14)
- Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections(Baseline to <Week 8 and Week 8 to <=Week 14)
研究者
研究点 (27)
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