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OpenTrials
Completed

NCT Number: NCT05091658

Period Tracker Lay User Study

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.

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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
  • 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.

Treatment and study plan

LH Urine Test

Device

Test for qualitative detection of LH in urine

Primary outcomes

  1. Lay user usage

    Time frame: 1 hour

    Ability of the lay user to perform a test and record their result

Secondary outcomes

  1. Comprehension of instructions for use

    Time frame: 1 hour

    Ability of the lay user to understand the information provided in the instructions for use

Other outcomes

  1. Lay user ability to read a high and a low result

    Time frame: 1 hour

    Ability of the lay user to score a positive result above a baseline result using the product scoring scale

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 25, 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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