Period Tracker at Home Study
Completed
- Conditions
- Menstrual Cycles
- Registration Number
- NCT05088382
- Lead Sponsor
- SPD Development Company Limited
- Brief Summary
This study will assess the usability of a Period Tracker product when used by lay users in their own homes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 126
Inclusion Criteria
- Female
- 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)
Exclusion Criteria
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Usability of the Period Tracker device when used at home 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
SPD Development Company Ltd
🇬🇧Bedford, Bedfordshire, United Kingdom