Clearblue Home Pregnancy Test Consumer Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SPD Development Company Limited
ClinicalTrials.gov Identifier:
NCT01279486
First received: December 24, 2010
Last updated: September 27, 2011
Last verified: September 2011

December 24, 2010
September 27, 2011
December 2010
June 2011   (final data collection date for primary outcome measure)
Consumer agreement [ Time Frame: Completion of laboratory testing ] [ Designated as safety issue: No ]
The agreement of the consumer Clearblue Pregnancy Test result with technician Clearblue Pregnancy Test results.
Same as current
Complete list of historical versions of study NCT01279486 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clearblue Home Pregnancy Test Consumer Study
Clearblue Home Pregnancy Test Consumer Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Urine samples

Non-Probability Sample

Volunteers requesting a pregnancy test

Pregnancy
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18-45 year old
  • Female
  • Requesting a pregnancy test

Exclusion Criteria:

Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01279486
PROTOCOL-0187
No
SPD Development Company Limited
SPD Development Company Limited
Not Provided
Principal Investigator: Kanagaratnam Shanmugaratnam National Health Service, United Kingdom
SPD Development Company Limited
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP