Period Tracker at Home Study

NCT05088382 | Completed

• 1 other identifier: PROTOCOL-1339
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the usability of a Period Tracker product when used by lay users in their own homes.

Conditions

Menstrual Cycles

Outcome Measures

Primary Outcomes (1)

• Usability of the Period Tracker device when used at home

  Number of users scoring 3 or less on a 7 point Likert scale for various questions related to usability of the Period Tracker device after use at home

  28 days (approximately 1 menstrual cycle)

Interventions

LH Urine Test DEVICE

Test for the qualitative measurement of LH in urine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Females are the intended user of this 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
• Menstrual cycles are 21-60 days long
• Seeking to predict when her next period will start
• Seeking to give informed consent and comply with the investigational procedures
• Has a compatible iPhone with internet access that they are willing to use for the study (iPhone 7+ and iOS 13 and above)

You may not qualify if:

• Currently pregnant or breastfeeding
• Used Clearblue® me (Period Tracker app), Persona Contraception Monitor or Clearblue Advanced Fertility Monitor 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
• Using any treatment which may affect the menstrual cycle (e.g. contraceptive pill)
• Using hormone replacement medications containing LH or hCG (e.g. Pregnyl®)
• Is currently seeking to conceive
• Has been diagnosed with polycystic ovarian syndrome (PCOS)
• Has PCOS symptoms e.g. very irregular cycles, hirsutism \*Immediate relatives are defined as parents, children, siblings or partner/spouse

Sponsors & Collaborators

• SPD Development Company Limited: lead

Study Sites (1)

SPD Development Company Ltd

Bedford, Bedfordshire, MK44 3UP, United Kingdom

Location

Study Officials

• Jackie Boxer

  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 21, 2021
• Study Start: August 4, 2021
• Primary Completion: November 3, 2021
• Study Completion: November 3, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Locations

GB (1)