NCT02833532已完成3 期
A Multi-center, Randomized, Subject Blind, Active Controlled Design Clinical Study to Evaluate the Efficacy and Safety of Volus as Compared to PowerFill® for Temporary Penile Enhancement
Hugel1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2015年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- the Penile Circumference difference at 24 weeks from Baseline value after using Volus application, compared to the Control.
研究概览
简要总结
The purpose of this study is to evaluate non-inferial study of the after using Volus application, 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
- Single (Participant)
入排标准
- 年龄范围
- 20 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 20 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?"
- •During the study period, subjects will not received any treatments associated with penile enhancement.
- •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
研究组 & 干预措施
Volus
Experimental
Maxium: 22ml
干预措施: Volus/Powerfill (Device)
Powerfill
Active Comparator
Maxium: 22ml
干预措施: Volus/Powerfill (Device)
结局指标
主要结局
the Penile Circumference difference at 24 weeks from Baseline value after using Volus application, compared to the Control.
时间窗: baseline, 24 weeks
Penile Circumference: The average of Distal-, Mid-, and Proximal-penis measurements when relaxed by tape measurement. Baseline value: Measured baseline length before the intervention.
次要结局
- The Difference in Penile Circumference (each to be measured) at 4, 12 weeks (post last treatment) from Baseline value after using Volus application, compared to the Control.(baseline, 4 weeks, 12 weeks, 24 weeks)
- The Difference in 5-point scale of penile appearance (each to be measured) at 4, 12, 24 weeks (post last treatment) from Baseline value after using Volus application, compared to the Control.(baseline, 4 weeks, 12 weeks, 24 weeks)
- The Difference in 5-point scale of sexual satisfaction (each to be measured) at 12, 24 weeks (post last treatment)from Baseline value after using Volus application, compared to the Control.(baseline, 12 weeks, 24 weeks)
- The Difference in penile length† (each to be measured) at 4, 12, 24 weeks (post last treatment) from ‡B after using Volus application, compared to the Control.(baseline, 4 weeks, 12 weeks, 24 weeks)
研究者
研究点 (1)
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