NCT05091658已完成不适用
Period Tracker Lay User Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Lay user usage
研究概览
简要总结
This study will assess the ability of the lay user to obtain and record a result. Comprehension of the instructions for use of the product will also be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 45 years
- •Willing to give informed consent and comply with the investigational procedures
排除标准
- •Used Clearblue® me Period Tracker app Persona or FAM within the last six months
- •Currently or previously employed by SPD, Abbott, Alere, Unipath, P&G or affiliates
- •Has an immediate* relative currently or previously (within past 5 years) employed by SPD, Abbott, Alere, Unipath or P&G, or affiliates
- •Is a qualified or trainee healthcare professional (HCP)
- •Has professional experience of using dipstick type tests or lateral flow devices
- •Currently breastfeeding, pregnant or seeking to conceive
- •Currently menstruating∆ *Immediate relatives are defined as parents, children, siblings or partner/spouse ∆Volunteer can start the study when their period has ended.
结局指标
主要结局
Lay user usage
时间窗: 1 hour
Ability of the lay user to perform a test and record their result
次要结局
- Comprehension of instructions for use(1 hour)
研究者
研究点 (1)
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