Period Tracker Lay User Study

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-14

Study Completion Date

2021-11-10

Brief Summary

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This study will assess the ability of the lay user to obtain and record a result. Comprehension of the instructions for use of the product will also be assessed.

Detailed Description

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Conditions

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Menstrual Cycles

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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LH Urine Test

Test for qualitative detection of LH in urine

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female
* Aged 18 to 45 years
* Willing to give informed consent and comply with the investigational procedures

Exclusion Criteria

* Used Clearblue® me Period Tracker app Persona or FAM 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
* Currently breastfeeding, pregnant or seeking to conceive
* Currently menstruating∆ \*Immediate relatives are defined as parents, children, siblings or partner/spouse ∆Volunteer can start the study when their period has ended.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sharon Bond

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

Site Status

Countries

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United Kingdom

Other Identifiers

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PROTOCOL-1337

Identifier Type: -

Identifier Source: org_study_id