Period Tracker at Home Study

• Sponsor: SPD Development Company Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05088382
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Actual Duration (Months): 3
• Patients Per Site Per Month: 42.1

Study Details

Study Description

Brief Summary

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

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

Study Design

• Study Type: Observational
• Actual Enrollment: 126 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Period Tracker at Home Study
• Actual Study Start Date: Aug 4, 2021
• Actual Primary Completion Date: Nov 3, 2021
• Actual Study Completion Date: Nov 3, 2021

Outcome Measures

Primary Outcome Measures

1. Usability of the Period Tracker device when used at home [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

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

• 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

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: Jackie Boxer, 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: NCT05088382
• Other Study ID Numbers: PROTOCOL-1339
• First Posted: Oct 21, 2021
• Last Update Posted: Nov 24, 2021
• Last Verified: Nov 1, 2021

• 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