Period Tracker Lay User Study

Menstrual Cycles Clinical Trial

Official title:

Period Tracker Lay User Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05091658
• Other study ID #: PROTOCOL-1337
• Status: Completed
• Start date: October 14, 2021
• Est. completion date: November 10, 2021

Study information

• Verified date: November 2021
• Source: SPD Development Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 10, 2021
• Est. primary completion date: November 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menstrual Cycles

Intervention

Device:
• LH Urine Test
Test for qualitative detection of LH in urine

Locations

Country	Name	City	State
United Kingdom	SPD Development Company Ltd	Bedford	Bedfordshire

Sponsors (1)

Lead Sponsor	Collaborator
SPD Development Company Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Lay user usage	Ability of the lay user to perform a test and record their result	1 hour
Secondary	Comprehension of instructions for use	Ability of the lay user to understand the information provided in the instructions for use	1 hour