Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
126 participants
OBSERVATIONAL
2021-08-04
2021-11-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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LH Urine Test
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
Yes
Sponsors
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SPD Development Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Jackie Boxer
Role: PRINCIPAL_INVESTIGATOR
SPD Development Company
Raniero Zazzeroni
Role: STUDY_DIRECTOR
SPD Development Company
Locations
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SPD Development Company Ltd
Bedford, Bedfordshire, United Kingdom
Countries
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Other Identifiers
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PROTOCOL-1339
Identifier Type: -
Identifier Source: org_study_id