NCT03512717已完成不适用
A Multi-center, Randomized, Subject-evaluator Blind, Active Controlled Design Clinical Study to Determine the Efficacy and Safety of Potenfill for Temporary Penile Enhancement
Medy-Tox2 个研究点 分布在 2 个国家目标入组 76 人开始时间: 2017年11月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- the Penile Circumference difference at 24 weeks from baseline
研究概览
简要总结
The purpose of this study is to evlauate the efficacy and safety of poteinfill, compared to the powerfill.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects aged above 19 and below
- •(20≤male≥65)
- •be rating himself, when screening, as "Small or Very Small" on Self-Questioned Questionnaire ( SQQ) including the question: " How do you rate your penile size? // Very small, Small, Normal, Big, Very Big?"
- •Subjects will sign an informed consent form
排除标准
- •Prior treatment for penile enhancement (e.g. fat, dermal graft).
- •Subjects who have penile malformation (e.g. Peyronie's disease), which can make impossible to perform the intervention
- •Allergic to hyalluronic acid.
- •Inflammatory or/and infectious disease on penis that can affect on this study
结局指标
主要结局
the Penile Circumference difference at 24 weeks from baseline
时间窗: 24 weeks
Penile Circumference: The average of Distal-, Mid-, and Proximal-penis measurements when relaxed by tape measurement
次要结局
未报告次要终点
研究者
研究点 (2)
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