临床试验/NCT00655590

NCT00655590已完成4 期

A Randomized, Double-blind, Placebo Controlled, Parallel Arm, Multicenter Trial Assessing the Effect of Daily Treatment of Vardenafil 20 mg or Sildenafil 100 mg Compared to Placebo on Spermatogenesis

Bayer0 个研究点目标入组 200 人开始时间: 2005年1月最近更新: 2014年12月30日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Bayer
入组人数: 200
主要终点: Proportion of vardenafil subjects with a 50% or greater decrease from baseline in mean sperm concentration at 6 months (LOCF), compared to placebo after repeated use

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

Assess the effect of daily treatment of vardenafil 20mg or sildenafil 100mg and placebo on sperm function

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: 25 Years 至 64 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Healthy male subjects or men with ED aged 25 - 64
•Baseline sperm conc. of > 20 mio / ml- Normal World Health Organization A+B+C sperm mortality > 50%- Normal sperm morphology (WHO, 1992 manual criteria) > 30% and - 1.0 mL ejaculate volume at each of the 3 analyses during the screening phase.

排除标准

•Presence of any psychological or physiological abnormalities that in the opinion of the Investigator would significantly impair sexual performance or ability to provide semen samples according to the protocol- Spinal cord injury
•History of surgical prostatectomy
•Other exclusion criteria apply according to US Product Information

研究组 & 干预措施

Arm 1

Experimental

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

Arm 2

Active Comparator

干预措施: Sildenafil (Drug)

Arm 3

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Proportion of vardenafil subjects with a 50% or greater decrease from baseline in mean sperm concentration at 6 months (LOCF), compared to placebo after repeated use

时间窗: 24 weeks

次要结局

Mean sperm concentration(24 weeks)
Mean sperm count(24 weeks)
Sperm morphology(24 weeks)
Sperm motility(24 weeks)
Reproductive hormones(24 weeks)
Proportion of sildenafil subjects with a 50% or greater decrease from baseline in mean sperm concentration at 6 months (LOCF), compared to placebo and vardenafil after repeated use(24 weeks)

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

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