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.

Study Overview

• Status: Completed
• Conditions: Menstrual Cycles
• Intervention / Treatment: Device: LH Urine Test

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• United Kingdom
  • Bedfordshire
    • Bedford, Bedfordshire, United Kingdom, MK44 3UP
      • SPD Development Company Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women between the ages of 18 to 45 represent the intended user of the product

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lay user usage	Ability of the lay user to perform a test and record their result	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comprehension of instructions for use	Ability of the lay user to understand the information provided in the instructions for use	1 hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lay user ability to read a high and a low result	Ability of the lay user to score a positive result above a baseline result using the product scoring scale	1 hour

Collaborators and Investigators

• Sponsor: SPD Development Company Limited
• Investigators: Principal Investigator: Sharon Bond, SPD Development Company

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 14, 2021
• Primary Completion (ACTUAL): November 10, 2021
• Study Completion (ACTUAL): November 10, 2021

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (ACTUAL): October 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PROTOCOL-1337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No