NCT00802763Unknown不适用
Performance Proof of the New NORMA-SENSE Panty Liner - in-Vivo STUD
Carmel Medical Center1 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2009年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- We will asses agreement between the color status of the NORMA-SENSE as reported by the subject after using the panty liner, and the pH measurement with Nitrazine paper.
研究概览
简要总结
This study was designed to validate the color appearance on the newly developed panty liner (NORMA-SENSE). The NORMA-SENSE liner changes color when worn by the user and comes into contact with vaginal secretion with an elevated pH level, without false positives due to urine remains or incontinence. The study will also asses the physical comfort in using NORMA-SENSE and the result reading clarity which includes the ability to visualize and interpret the NORMA-SENSE strip results.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women, age 18 years or greater without symptoms of vaginal infection.
- •Subject is ready to sign the informed consent form.
排除标准
- •Subject is unable or unwilling to cooperate with study procedures.
- •Subject is currently participating in another clinical study.
- •Subject suffers from vaginal bleeding or is menstruating.
- •Subject that have had sexual relations within the last 12 hours.
- •Subject that applied local antiseptic or antibiotic or vaginal treatment within the last 3 days.
- •Subject that applied vaginal douching within 12 hours prior to the visit at the clinic.
结局指标
主要结局
We will asses agreement between the color status of the NORMA-SENSE as reported by the subject after using the panty liner, and the pH measurement with Nitrazine paper.
时间窗: 1 week
次要结局
未报告次要终点
研究者
研究点 (1)
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