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OpenTrials
Completed

NCT Number: NCT05088382

Period Tracker at Home Study

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

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Key information

Conditions

Menstrual Cycles

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

SPD Development Company Ltd

Bedford, Bedfordshire, MK44 3UP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LH Urine Test

Device

Test for the qualitative measurement of LH in urine

Primary outcomes

  1. Usability of the Period Tracker device when used at home

    Time frame: 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

Sponsors and collaborators

Lead sponsor

SPD Development Company Limited

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 21, 2021
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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