NCT00678704已完成3 期
A Randomized, Placebo-controlled, Double-blind, Multi-centre, Parallel Group Study to Investigate the Efficacy and Safety of BAY 38-9456 in Males With Diabetes Suffering From Erectile Dysfunction
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 790
- 主要终点
- The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15
研究概览
简要总结
The superiority of BAY 38-9456 10 mg and 20 mg regimens to placebo, and of 20 mg to 10 mg was confirmed in patients with diabetes mellitus suffering from erectile dysfunction. There was no large difference in incidence rate of drug-related adverse events between 10 mg and 20 mg regimens. Overall the tolerability was considered good with both regimens.
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
- 20 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male with erectile dysfunction for more than 3 years according to the National Institutes of Health (NIH) Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
- •Diabetes for more than 3 years
排除标准
- •Following to the labeling of Japanese package insert for vardenafil 5/10 mg, except for the highest dose
- •Spinal cord injury
- •History of surgical prostatectomy (excluding TURP)
- •Patients with an HbA1c > 12% at Visit 1
- •Use of nitrates
- •Use of potent CYP3a4 inhibitors
- •Severe liver disease
- •Presence of Peyronie's Disease
研究组 & 干预措施
Arm 3
Placebo Comparator
干预措施: Placebo (Drug)
Arm 1
Experimental
干预措施: Levitra (Vardenafil, BAY38-9456) (Drug)
Arm 2
Experimental
干预措施: Levitra (Vardenafil, BAY38-9456) (Drug)
结局指标
主要结局
The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15
时间窗: At 12 weeks after start of study drug administration using data at LOCF to account for dropouts
次要结局
- The Global Assessment Question(At 4, 8, 12 weeks after start of study drug administration and LOCF)
- The IIEF EF domain score(At 4, 8, 12 weeks after start of study drug administration)
- IIEF domain scores other than the EF domain score[intercourse satisfaction (Q6 to Q8), overall satisfaction (Q13, Q14), orgasmic function (Q9, Q10), sexual desire (Q11, Q12)](At 4, 8, 12 weeks after start of study drug administration and LOCF)
- Scores of Questions 1 to 15 on the IIEF Questionnaire(At 4, 8, 12 weeks after start of study drug administration and LOCF)
- Patient's diary response concerning hardness of erection, maintenance of erection, satisfaction with overall hardness of erection, ability of insertion, overall satisfaction with sexual experience and ejaculation(At 4, 8, 12 weeks after start of study drug administration and LOCF)
- Safety data(Throughout the study)
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