Period Tracker Lay User Study

• Sponsor: SPD Development Company Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05091658
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Actual Duration (Days): 27
• Patients Per Site Per Month: 135.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Menstrual Cycles	Device: LH Urine Test

Study Design

• Study Type: Observational
• Actual Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Period Tracker Lay User Study
• Actual Study Start Date: Oct 14, 2021
• Actual Primary Completion Date: Nov 10, 2021
• Actual Study Completion Date: Nov 10, 2021

Outcome Measures

Primary Outcome Measures

1. Lay user usage [1 hour]

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

Secondary Outcome Measures

1. Comprehension of instructions for use [1 hour]

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

Other Outcome Measures

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SPD Development Company Ltd	Bedford	Bedfordshire	United Kingdom	MK44 3UP

Sponsors and Collaborators

• SPD Development Company Limited

Investigators

• Principal Investigator: Sharon Bond, SPD Development Company
• Study Director: Raniero Zazzeroni, SPD Development Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SPD Development Company Limited
• ClinicalTrials.gov Identifier: NCT05091658
• Other Study ID Numbers: PROTOCOL-1337
• First Posted: Oct 25, 2021
• Last Update Posted: Nov 24, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 24, 2021