A Phase 4, Open-Label, Non-Randomized, Clinical Trial to Evaluate the Efficacy, Safety and Satisfaction of VITAROS (Transdermal Topical Alprostadil) in Men With Erectile Dysfunction.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The efficacy of Topical alprostadil in the treatment of erectile dysfunction as measured by IIEF scores.
研究概览
简要总结
A Phase 4 clinical trial that is open, with no blinding of subjects or randomization of treatment. Patients with erectile problems will be given the approved drug Vitaros to treat their condition. They will be given forms and questionnaires to complete. The information collected will be used to assess the effectiveness, safety and the satisfaction levels with this drug.
详细描述
Transdermal topical alprostadil has been approved for use in Canada as a treatment for erectile dysfunction. However, as this form of treatment is new, and Canada is the first country in the world to approve its use. There are very few published articles in literature to evaluate its clinical acceptance. By performing a Phase 4, Open-Label, Non-Randomized, Clinical Trial to Evaluate the Efficacy, Safety and Satisfaction of VITAROS (transdermal topical alprostadil) in Men with Erectile Dysfunction, this study can improve understanding of this method of treatment as compared to conventional treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •18y rs old and above
- •Has mild-to-moderate erectile dysfunction
- •Currently or previous treated for erectile dysfunction using PDE5 inhibitors, vacuum erection devices (VED), intra-cavernosal injections (ICI) and medical urethral system for erection (MUSE).
- •Sexually active
- •Has a regular sexual partner
排除标准
- •Known allergy to alprostadil
- •Unable to provide own informed consent
- •Unable to understand and complete a questionnaire in English
- •Unable to return for a post-treatment clinic evaluation
- •Regular sexual partner is unable to understand and complete a questionnaire in English
- •Sexual partner is a pregnant or lactating female
研究组 & 干预措施
VITAROS
VITAROS (Alprostadil) 330 ug PRN (as needed) transdermal topical 4-8 weeks
干预措施: Alprostadil (Drug)
结局指标
主要结局
The efficacy of Topical alprostadil in the treatment of erectile dysfunction as measured by IIEF scores.
时间窗: 4 - 8weeks
次要结局
- Evaluate patient satisfaction of transdermal topical alprostadil when compared to patient's most current mode of therapy for erectile dysfunction.(4 - 8 weeks)
研究者
Gerald Brock
Professor
Lawson Health Research Institute