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临床试验/NCT00273416
NCT00273416已完成2 期

A Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses Of PF-00592379 On Erectile Function, Using 100mg Sildenafil As A Positive Control

Pfizer3 个研究点 分布在 2 个国家目标入组 32 人开始时间: 2006年1月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
Pfizer
入组人数
32
试验地点
3
主要终点
Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM).

研究概览

简要总结

The primary aim of this study is to assess how effective PF-00592379 is in restoring penile erections in patients with erectile dysfunction. Patients will attend for 4 treatment visits where they will receive the following in random order; 2 separate doses of PF-00592379, sildenafil 100mg used as a positive control, or placebo (dummy medication). The effect on penile erections will be assessed in the clinic using penile plethysmography (RigiScan PlusTM technique).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Erectile dysfunction, previous good response to an oral treatment for erectile dysfunction.

排除标准

  • Patients with high blood pressure or certain heart conditions (e.g. angina, heart failure), regardless of whether treated or not.
  • Patients on nitrates or alpha-blocker medications.

结局指标

主要结局

Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM).

次要结局

  • Duration and quality of penile erections recorded in a self-assessment diary.

研究者

发起方
Pfizer
申办方类型
Industry

研究点 (3)

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