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Consumer in Stream and Container Collected Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SPD Development Company Limited
ClinicalTrials.gov Identifier:
NCT01577901
First received: April 11, 2012
Last updated: August 14, 2012
Last verified: July 2012
  Purpose

Female volunteers, requiring to conduct a personal pregnancy test will use Clearblue Advanced Pregnancy test, following the instructions for use. The test will be conducted following both the instructions for the in stream method of sampling and the method of testing when a sample is collected into a container. The results will be compared to those achieved by the study technician.


Condition Intervention
Determination of Pregnancy Status
Other: Clearblue Advanced

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Consumer in Stream and Container Collected Study

Further study details as provided by SPD Development Company Limited:

Primary Outcome Measures:
  • number of pregnant volunteers as determined by volunteer test result. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Comparison of the performance of the Clearblue Advanced Pregnancy Test in consumer hands when tested using the in-stream method of testing with the performance of the device when used by a study coordinator when testing the same urine sample using the method for urine collected into a container.


Enrollment: 168
Study Start Date: March 2012
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Clearblue Advanced
    Pregnancy test
Detailed Description:

The study will compare the performance of the Clearblue Advanced Pregnancy Test, when used by consumers according to the instructions for use leaflet (IFUL), and by trained coordinators. Consumer testing will include both sampling in the urine stream and the testing method for urine collected into a container.

In addition, the performance of the Clearblue Advanced Pregnancy Test will be compared to that of the currently marketed Clearblue Digital Pregnancy Test for the detection of pregnancy. In this comparison, both tests will be performed by a trained coordinator using the testing method for urine collected into a container on each volunteer's urine sample.

The study will involve the recruitment of a cross-section of the target pregnancy test users in the United Kingdom, that is, women aged 18-45 who are seeking a pregnancy test. The study will aim to recruit at least 100 volunteers, a minimum of 30 (30%) of whom will be pregnant.

Volunteers will use the Clearblue Advanced Pregnancy Test device using the urine stream method of sampling according to the product instructions. In addition volunteers will be asked to collect a urine sample from the same void and conduct a second Clearblue Advanced Pregnancy Test, using the testing method for urine collected in a container. The volunteer will then complete a study questionnaire on ease of use and leaflet comprehension. The questionnaire, urine sample and used devices will be retained by SPD for evaluation Agreement between the volunteer Pregnancy Test result and study coordinator Pregnancy Test result will be reported.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Requiring a pregnancy test
  • Willing to provide informed consent and reveal pregnancy status

Exclusion Criteria:

  • Employees of SPD. Unipath, Alere or P&G Previous participation in study Previously used Clearblue Advanced Pregnancy Test.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577901

Locations
United Kingdom
SPD Development Company Ltd.
Bedford, Bedfordshire, United Kingdom, MK44 3UP
Sponsors and Collaborators
SPD Development Company Limited
Investigators
Principal Investigator: Pauline A Parkinson, BSc SPD Development Company Limited
  More Information

No publications provided

Responsible Party: SPD Development Company Limited
ClinicalTrials.gov Identifier: NCT01577901     History of Changes
Other Study ID Numbers: PROTOCOL-0425
Study First Received: April 11, 2012
Last Updated: August 14, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by SPD Development Company Limited:
Pregnancy

ClinicalTrials.gov processed this record on November 24, 2014