NCT05088382已完成不适用
Period Tracker at Home Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Usability of the Period Tracker device when used at home
研究概览
简要总结
This study will assess the usability of a Period Tracker product when used by lay users in their own homes.
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
- •Menstrual cycles are 21-60 days long
- •Seeking to predict when her next period will start
- •Seeking to give informed consent and comply with the investigational procedures
- •Has a compatible iPhone with internet access that they are willing to use for the study (iPhone 7+ and iOS 13 and above)
排除标准
- •Currently pregnant or breastfeeding
- •Used Clearblue® me (Period Tracker app), Persona Contraception Monitor or Clearblue Advanced Fertility Monitor 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
- •Using any treatment which may affect the menstrual cycle (e.g. contraceptive pill)
- •Using hormone replacement medications containing LH or hCG (e.g. Pregnyl®)
- •Is currently seeking to conceive
- •Has been diagnosed with polycystic ovarian syndrome (PCOS)
- •Has PCOS symptoms e.g. very irregular cycles, hirsutism *Immediate relatives are defined as parents, children, siblings or partner/spouse
结局指标
主要结局
Usability of the Period Tracker device when used at home
时间窗: 28 days (approximately 1 menstrual cycle)
Number of users scoring 3 or less on a 7 point Likert scale for various questions related to usability of the Period Tracker device after use at home
次要结局
未报告次要终点
研究者
研究点 (1)
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