Period Tracker Lay User Study
Completed
- Conditions
- Menstrual Cycles
- Registration Number
- NCT05091658
- Lead Sponsor
- SPD Development Company Limited
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 120
Inclusion Criteria
- Female
- Aged 18 to 45 years
- Willing to give informed consent and comply with the investigational procedures
Exclusion Criteria
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Lay user usage 1 hour Ability of the lay user to perform a test and record their result
- Secondary Outcome Measures
Name Time Method Comprehension of instructions for use 1 hour Ability of the lay user to understand the information provided in the instructions for use
Trial Locations
- Locations (1)
SPD Development Company Ltd
🇬🇧Bedford, Bedfordshire, United Kingdom