Period Tracker at Home Study

Swiss Precision Diagnostics (SPD)

Status: Completed

Conditions: Menstrual Cycles

Treatments: Device: LH Urine Test

Study type: Observational

Funder types: Industry

Identifiers

NCT05088382

PROTOCOL-1339

Details and patient eligibility

About

This study will assess the usability of a Period Tracker product when used by lay users in their own homes.

Enrollment: 126 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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