Period Tracker Lay User Study

NCT05091658 | Completed

• 1 other identifier: PROTOCOL-1337
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Menstrual Cycles

Outcome Measures

Primary Outcomes (1)

• Lay user usage

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

  1 hour

Secondary Outcomes (1)

• Comprehension of instructions for use

  1 hour

Other Outcomes (1)

• Lay user ability to read a high and a low result

  1 hour

Interventions

LH Urine Test DEVICE

Test for qualitative detection of LH in urine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Females are representative of the intended user of the product
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Female
• Aged 18 to 45 years
• Willing to give informed consent and comply with the investigational procedures

You may not qualify if:

• 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.

Sponsors & Collaborators

• SPD Development Company Limited: lead

Study Sites (1)

SPD Development Company Ltd

Bedford, Bedfordshire, MK44 3UP, United Kingdom

Location

Study Officials

• Sharon Bond

  SPD Development Company

  PRINCIPAL INVESTIGATOR

• Raniero Zazzeroni

  SPD Development Company

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 25, 2021
• Study Start: October 14, 2021
• Primary Completion: November 10, 2021
• Study Completion: November 10, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)