NCT02496845Unknown1 期
An Open Label Randomized Study to Examine the Safety and Clinical Efficacy of Local Topical Dual Active Preparation for Erectile Dysfunction
VasoLead (2012) Ltd.1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events as a aeasure of safety and tolerability of topical VL#FIA3-30 applied on the penis
研究概览
简要总结
VL#FIA3-30 is a preparation intended for topical use, applied on the penis, for the treatment of ED.
详细描述
VasoLead's preparation to treat erectile dysfunction (ED), VL#FIA3-30, is composed of 2 active pharmaceutical ingredients, both act as vasodilators via different mechanisms. Both are currently used orally in the USA and Europe for the treatment of hypertension, angina pectoris and other diseases.
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
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent.
- •ED for more than six months in duration.
- •IIEF-EF domain score at baseline from 11 to 19 .
- •Willingness for a minimum of two sexual attempts during the short period of this study.
- •At least 50% unsuccessful sexual intercourse for 4 attempts on 4 different days.
- •A stable heterosexual relationship with the same partner for more than six months.
- •Age 25 to 75 years old.
排除标准
- •Neurological pathology;
- •Prior radical prostatectomy;
- •Any unstable medical or psychiatric condition, spinal cord injury, or penile anatomical abnormalities;
- •Clinically significant chronic hematological disease;
- •Cardiovascular conditions that prevent sexual activity (CHF or severe coronary artery disease);
- •History of myocardial infarction, stroke, or life-threatening arrhythmia within 6 months prior to enrollment into the study;
- •Use of anti-androgens, or oral or injectable androgens;
- •Documented hypotension (BP below 100 systolic or 70 diastolic) or known orthostatic hypotension;
- •Routine use of more than 2 antihypertensive medications;
- •Use of oral nitrates within 3 months prior to enrollment into the study;
- •Cancer within the last 3 years;
- •Documented allergic reaction;
- •Investigators impression for patient non-compliance;
- •Hepatic or renal failure;
- •History of HIV, hepatitis B, hepatitis C;
- •Is an immediate family member of personnel directly affiliated with the study at the investigative site, or is personally directly affiliated with the study at the investigative site;
- •Subject has taken any investigational medication within 30 days prior of entry into the study
- •Employed by VasoLead (2012) Ltd.
研究组 & 干预措施
Group A
Experimental
Topical treatment and PK. Administration of VL#FIA3-30 (dual administration of MH30-01 & IS045-01)
干预措施: VL#FIA3-30 (Drug)
Groups B, C, D
Experimental
Dual topical biweekly administration and intraurethral. Triple topical weekly administration. Multiple topical administration. Administration of VL#FIA3-30 (dual administration of MH30-01 & IS045-01)
干预措施: VL#FIA3-30 (Drug)
结局指标
主要结局
Number of participants with adverse events as a aeasure of safety and tolerability of topical VL#FIA3-30 applied on the penis
时间窗: 2 weeks
次要结局
- Improvement of patient/Investigator satisfaction VAS score(2 weeks)
- Increase points of the International Index of Erectile Function-Erectile Function (IIEF-EF) score(2 weeks)
- Increase the score level of the Erection Hardness Score (EHS) index(2 weeks)
- Increase the total score of the modified Quality of Erection Questionnaire (mQEQ)(2 weeks)
- Increase the total score of the Quality of Erection Questionnaire (QEQ)(2 weeks)
- Significant increase of Flow Mediated Dilation (FMD) parameters(2 weeks)
- Increase the total ED inventory of Treatment Satisfaction (EDITS) score(2 weeks)
研究者
研究点 (1)
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