Period Tracker Lay User Study

Swiss Precision Diagnostics (SPD)

Status: Completed

Conditions: Menstrual Cycles

Treatments: Device: LH Urine Test

Study type: Observational

Funder types: Industry

Identifiers

NCT05091658

PROTOCOL-1337

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.