跳至主要内容
临床试验/NCT00778934
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

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

申办方类型
Industry
责任方
Sponsor

研究点 (4)

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