Double-blind, Placebo Controlled, Randomized Study of Vardenafil to Determine Efficacy on Erectile Dysfunction (ED) in Men With ED and Metabolic Syndrome (ED-METABOLIC)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 150
- 主要终点
- Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF)
研究概览
简要总结
This is a controlled, randomized, multi-center prospective study of vardenafil to determine efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic Syndrome. This study will explore the rate of patients who do need to switch to the highest dosage based upon the expectation that most men can stay on vardenafil 10 mg PRN (pro re nata)
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
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Stable heterosexual relationship
- •History of erectile dysfunction for at least 6 months
- •IIEF- EF Domain entry score (at Visit 2): >21 points
- •Documented metabolic syndrome according to the IDF (International Diabetes Foundation)
- •Subjects motivated for erectile dysfunction treatment
- •Documented, dated, written informed consent
排除标准
- •Any underlying cardiovascular condition
- •History of myocardial infarction
- •Uncontrolled atrial fibrillation
- •Resting hypotension
- •Postural hypotension within 6 months of Visit 1
- •History of congenital QT prolongation
- •Bleeding disorder
- •History of prostatectomy because of prostate cancer
- •Hereditary degenerative retinal disorders
- •History of loss of vision because of NAION (non-arteritic anterior ischemic optic neuropathy)
- •29 Additional Exclusion Criteria
研究组 & 干预措施
Vardenafil (Levitra, BAY38-9456)
Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
干预措施: Vardenafil (Levitra, BAY38-9456) (Drug)
Placebo
Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF)
时间窗: baseline and up to 8 weeks or LOCF
The primary variable was the least square (LS)-mean difference between treatment groups in the IIEF-EF domain score (6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no erectile dysfunction \[ED\]'). The target variable is the LS-mean difference between treatment groups at endpoint. The LS-means of both treatment groups are derived from a baseline-adjusted endpoint measure (week 8/last observation carried forward \[LOCF\]) as calculated via an ANCOVA.
Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8
时间窗: Baseline and 8 weeks
Percent successful penetrations were calculated per participant as the number of successful sexual attempts (penetrations) divided by the total number of attempts. The mean percent successful penetrations was then calculated across all participants.
Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8
时间窗: Baseline and 8 weeks
Percent successful maintenance of erection were calculated per participant as the number of successful attempts (maintenance of erection) divided by the total number of attempts. The mean percent successful maintenance of erection was then calculated across all participants.
次要结局
- Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8(Baseline and 8 weeks)
- Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8(Baseline and 8 weeks)
- Percentage of Participants Achieving "Back to Normal" Erectile Function at Week 8 or Last Observation Carried Forward (LOCF)(up to 8 weeks or LOCF)
- Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata))(week 4 and week 8)