NCT00779025已完成不适用
A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions
Johnson & Johnson Consumer and Personal Products Worldwide2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2008年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Number of Participants Showing Change From Baseline in Irritation Scores
研究概览
简要总结
The purpose of this study is to study in couples and to evaluate the safety of personal lubricant products.
详细描述
Study to evaluate the safety of Class II personal lubricant devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal, healthy males and females >18 years of age
- •In committed heterosexual relationship for >6months
- •On acceptable method of birth control
排除标准
- •Pregnant or breastfeeding
- •Allergy to product ingredients
- •Irritation or infection in genital area
- •Unstable or uncontrolled medical condition
结局指标
主要结局
Number of Participants Showing Change From Baseline in Irritation Scores
时间窗: 1 week
Number of participants showing change in irritation scores based on physical examinations of both male and female subjects according to a 6-point scale, ranging from 0=Normal appearance, no irritation to 6 = Presence of Lesions
次要结局
- Number of Sensations Experienced by Male Subjects - Overall(1 Week)
- Number of Sensations Experienced by Female Subjects - Overall(1 Week)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
A Single-Center, Clinical Study to Evaluate the Safety of a Non-Fragranced Personal Lubricant in Healthy Female SubjectsErythemaEdemaNCT02320227Church & Dwight Company, Inc.30
已完成
不适用
Safety Study of a Sensitive Sensual Touch and Personal LubricantInadequate LubricationNCT01271036Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.124
已完成
不适用
Safety Study for an All-in-One Body and Personal LubricantLubricating AgentsNCT01189617Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.70
已完成
不适用
A Single-Center, Clinical Study to Evaluate the Safety of a Fragranced Personal Lubricant in Healthy Female SubjectsErythemaEdemaNCT02320214Church & Dwight Company, Inc.30
已完成
不适用
A Clinical Study to Evaluate the Safety of a Personal Lubricant in Healthy Female SubjectsErythemaEdemaNCT02737592Church & Dwight Company, Inc.34