NCT01220206已完成2 期
A Randomized, Placebo-Controlled, Double-Blind, Parallel Design Trial to Evaluate the Safety and Efficacy of POM Wonderful Pomegranate Extract Capsules In Male Subjects With Moderate to Severe Erectile Dysfunction
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Effects on ED
研究概览
简要总结
POMx can be used as a treatment for erectile dysfunction.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male 21 to 70 years old
- •Erectile Function domain score of 10-19 on the International Index of Erectile Function (IIEF)
- •In a stable, monogamous relationship with a consenting female partner and willing to attempt vaginal sexual intercourse on at least one occasion per week on average during each study period
- •History of ED (clinically defined as the inability to attain and maintain an erection of the penis sufficient to permit satisfactory sexual intercourse) of at least 3 months duration
- •Treated previously with a PDE-5 inhibitor with a satisfactory response, as defined by the patient.
- •Signed informed consent
排除标准
- •The presence of any of the following excludes a subject from study enrollment: ED caused by untreated endocrine disease, i.e., hypopituitarism, hypothyroidism, hypogonadism
- •A diagnosis of situational psychogenic ED
- •Significant penile pathology, including but not limited to curvature, fibrosis, sexually transmitted disease, and penile implant
- •Clinically significant hepatic, renal, neurological disease, diabetes mellitus, spinal cord injury, significant coronary heart disease, significant neurological disease or hepatitis B and/or C
- •History of prostate cancer or prostate surgery other than a transurethral resection of the prostate
- •History of alcoholism within the previous 2 years
- •Current consumer of three or more units of alcohol per day (1 unit is equivalent to 1 glass of wine, 1 pint of beer, or 1 shot of hard liquor)
- •Taking ED therapy (prescription medications, over-the-counter medications, herbal preparations or medical devices) after the screening visit
- •Participation in another study with an investigational drug or device during the 30 days prior to study entry
- •Has a condition interfering with his ability to provide informed consent or comply with study instructions
研究组 & 干预措施
Placebo
Placebo Comparator
2 placebo capsules daily
干预措施: Placebo (Drug)
one POMx capsule
Experimental
One POMx capsule, one placebo capsule daily
干预措施: One POMx capsule daily (Drug)
2 POMx Capsules
Experimental
2 POMx Capsules daily
干预措施: 2 POMx Capsules (Drug)
结局指标
主要结局
Effects on ED
时间窗: Basedline to end of study
There are three co-primary endpoints: Erectile Function domain score (questions 1-5 and 15 of the IIEF), and questions 2 and 3 on the SEP diary
次要结局
- Effect on ED(baseline to end of study)
研究者
研究点 (1)
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