Period Tracker at Home Study

Menstrual Cycles Clinical Trial

Official title:

Period Tracker at Home Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05088382
• Other study ID #: PROTOCOL-1339
• Status: Completed
• Start date: August 4, 2021
• Est. completion date: November 3, 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 usability of a Period Tracker product when used by lay users in their own homes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: November 3, 2021
• Est. primary completion date: November 3, 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

• 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

Related Conditions & MeSH terms

• Menstrual Cycles

Intervention

Device:
• LH Urine Test
Test for the qualitative measurement 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
Primary	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)