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NCT01279486 Clinical Trial

Clearblue Home Pregnancy Test Consumer Study

Pregnancy Clinical Trial

Official title:
Clearblue Home Pregnancy Test Consumer Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01279486
Other study ID # PROTOCOL-0187
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2010
Est. completion date June 2011

Study information
Verified date January 2018
Source SPD Development Company Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Approximately 120 female volunteers requesting a pregnancy test will be recruited locally to the UK trial centre.

Volunteers will be required to use the Clearblue Pregnancy Test according to the product instructions, and provide a urine sample from the same void.

Trained technicians will conduct a second test from the urine sample.

Description:

Approximately 120 female volunteers attending the study site requesting a pregnancy test will be recruited locally to the UK trial centre.

Volunteers will be required to use the Clearblue Pregnancy Test according to the product instructions, and provide a urine sample from the same void.

Trained technicians will conduct a second test from the urine sample to evaluate performance between consumer and technician testing.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- 18-45 year old

- Female

- Requesting a pregnancy test

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Bedford General Hospital Bedford Bedfordshire
United Kingdom Brook clinic Milton Keynes

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 Consumer Agreement The agreement of the consumer Clearblue Pregnancy Test result with technician Clearblue Pregnancy Test results when testing the same sample. During testing approximately 15 minutes
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