NCT00778934已完成不适用
A Single-blind, Multi-center, In-home Use Study to Evaluate Sexual Enhancement Effects of Product PD-F-5394 in Females
Johnson & Johnson Consumer and Personal Products Worldwide4 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2007年12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
- 79
- 试验地点
- 4
- 主要终点
- To assess the effect of product on sexual enhancement by comparing baseline questionnaire responses to the end of study questionnaire responses
研究概览
简要总结
The purpose of this study is to evaluate the effects of an intimate health product on sexual experience in females.
详细描述
Study to evaluate consumer perceptions of a cosmetic intimate health product on sexual experience in females, using a validated psychometric questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal, healthy females >18 years of age
- •In committed heterosexual relationship for >6months
- •Of adequate sexual functioning
- •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
To assess the effect of product on sexual enhancement by comparing baseline questionnaire responses to the end of study questionnaire responses
时间窗: End of study (3 weeks after baseline visit)
次要结局
- Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product.(throughout duration of the study (+ 30 days for spontaneously reported SAEs))
研究者
研究点 (4)
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