临床试验/NCT00661596

NCT00661596已完成3 期

Multi-centre, Randomised, Double-blind, Parallel, Placebo-controlled Clinical Study to Assess the Efficacy of Vardenafil and Its Influence on Self-esteem and Self-confidence in Patients With Erectile Dysfunction

Bayer0 个研究点目标入组 129 人开始时间: 2003年5月最近更新: 2014年12月30日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Bayer
入组人数: 129
主要终点: International Index of Erectile Function - Erectile Function Domain

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Erectile problems may lead to anxiety, loss of self-esteem and depression and/or stress. The purpose of this national study was to determine if vardenafil is effective in treating impotent men (erectile dysfunction) and evaluate its influence in self-esteem and self-confidence. During the visits the patients was asked some questions about erections, and he fill different questionnaires about sexuality, mood, feelings, self-esteem and sexual activity.

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 —（Adult, Older Adult）
性别: Male
接受健康志愿者: 否

入选标准

•Age: 18 years and older
•Males with erectile dysfunction
•Stable heterosexual relationship

排除标准

•Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
•Nitrate use
•Other exclusion criteria apply acc. to Summary of Product Characteristics

研究组 & 干预措施

Arm 1

Experimental

干预措施: Levitra (Vardenafil, BAY38-9456) (Drug)

Arm 2

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

International Index of Erectile Function - Erectile Function Domain

时间窗: 12 weeks

次要结局

Other diary based variables(12 weeks)
Safety and tolerability(12 weeks)
Global Assessment Questionnaire(12 weeks)
IIEF-EF domain score(12 weeks)

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

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