Menstrual Cycles
Conditions
Brief summary
This study will assess the usability of a Period Tracker product when used by lay users in their own homes.
Interventions
DEVICELH Urine Test
Test for the qualitative measurement of LH in urine
Sponsors
SPD Development Company Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Kingdom
Outcome results
None listed