A Safety Evaluation of Personal Lubricant Product When Used by Couples in Home-use Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 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
研究组 & 干预措施
MINE Alone
Female Personal Lubricant (PD-F-5254)
干预措施: PD-F-5254 (Device)
YOURS and MINE
Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
干预措施: PD-F-5254 (Device)
YOURS and MINE
Male Personal Lubricant (10855-096) used in conjunction with Female Personal Lubricant (PD-F-5254)
干预措施: 10855-096 (Device)
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)