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Project-0027. Lay User Usage Study

NCT02636166 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 943

Last updated 2015-12-21

No results posted yet for this study

Summary

Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial centre and provide a sample of urine from the same void for further testing.

Volunteers will then complete a product usage questionnaire and leaflet comprehension questionnaire at site.

Follow-up information will be required from all volunteers as both additional urine sample(s) and pregnancy information to establish true pregnancy status at the study visit.

Conditions

  • Pregnancy

Interventions

OTHER

Clearblue Investigational Pregnancy test

Clearblue Investigational Pregnancy test

OTHER

Professional pregnancy test

Alere Professional use pregnancy test

OTHER

Clearblue Marketed Pregnancy test

Clearblue Marketed Pregnancy test

Sponsors & Collaborators

  • Illingworth Research Ltd

    collaborator UNKNOWN

  • SPD Development Company Limited

    lead INDUSTRY

Principal Investigators

  • Juliet Hulse · Illingworth Research Ltd

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2015-11-30
Completion
2015-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02636166 on ClinicalTrials.gov