NCT00693056已完成2 期
A Double-Blinded, Randomized, Placebo-Controlled, Dose-Exploring Study of RX-10100 for Eight Weeks of On-Demand Administration in Subjects With Erectile Dysfunction (ED)
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
- 40
- 主要终点
- Scores on IIEF-EF Questionnaires and on SEP Questions II and III
研究概览
简要总结
The primary objective of this Phase IIa trial is to determine the effective doses and treatment period for an upcoming RX-10100 Phase IIb trial in subjects with erectile dysfunction (ED). The secondary objectives of this trial are to evaluate the safety and the quality of life in subjects with ED receiving RX-10100 treatment.
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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Have had ED for at least six months
- •Stable, heterosexual relationship for at least 3 months
- •Make at least one attempt of sexual intercourse per week during the untreated, 2-week screening period
- •At least 50% of attempts of sexual intercourse during the untreated baseline period must be unsuccessful
- •'Moderate' or 'mild to moderate' ED, defined as an IIEF-EF domain score between 11 and 21 measured
排除标准
- •Following previous or current medical conditions
- •Any unstable medical, psychiatric, or substance abuse disorder
- •Penile anatomical abnormalities
- •Primary hypoactive sexual desire
- •Spinal cord injury
- •Hypogonadism
- •Surgical prostatectomy
- •Stable or unstable angina pectoris
- •Myocardial infarction, stroke, or life-threatening arrhythmia
- •Uncontrolled atrial fibrillation/flutter at screening
- •Severe chronic or acute liver disease
- •Moderate or severe hepatic impairment
- •Clinically significant chronic hematological disease
- •Bleeding disorder
- •Significant active peptic ulcer disease
- •Resting hypotension or hypertension
- •Malignancy (cancers)
- •NYHA Class II to IV heart failures
- •Positive test for Hepatitis B surface antigen (HBsAg) or Hepatitis C
- •Symptomatic postural hypotension
- •Following concomitant medication
- •Androgens or estrogens
- •Anti-androgens
- •Potent inhibitors of cytochrome P450 3A4
- •Any other investigational drug within 30 days before Visit 1
- •Any treatment for ED within 7 days before Visit 1 or during the study
- •Antibiotics in the penicillin class
- •Following abnormal laboratory values
- •Serum total testosterone level (at least 25% lower)
- •Serum creatinine (> 3.0 mg/dl)
- •Elevation of AST and/or ALT (> 3 times the upper limit of normal)
- •Diabetic subjects with an HbAlc (> 6.5%)
- •Subjects with known hypersensitivity to amoxicillin
- •Subjects with a history of unresponsiveness to any PDE5 Inhibitor treatment or a history of significant side effects leading to its treatment discontinuation
研究组 & 干预措施
1
Placebo Comparator
干预措施: Placebo (Drug)
2
Experimental
干预措施: RX-10100 5mg (Drug)
3
Experimental
干预措施: RX-10100 10mg (Drug)
4
Experimental
干预措施: RX-10100 15mg (Drug)
结局指标
主要结局
Scores on IIEF-EF Questionnaires and on SEP Questions II and III
时间窗: Weeks 4 and 8
次要结局
- Scores on other domains of IIEF, other questions on Subject Diaries, RigiScan measurement, and ED-QoL questionnaires(Weeks 4 and 8)
研究者
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