Period Tracker at Home Study

November 23, 2021 updated by: SPD Development Company Limited
This study will assess the usability of a Period Tracker product when used by lay users in their own homes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

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
  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability of the Period Tracker device when used at home
Time Frame: 28 days (approximately 1 menstrual cycle)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SPD Development Company Limited

Investigators

  • Principal Investigator: Jackie Boxer, SPD Development Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2021

Primary Completion (Actual)

November 3, 2021

Study Completion (Actual)

November 3, 2021

Study Registration Dates

First Submitted

October 12, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 21, 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-1339

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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