Home Pregnancy Test Evaluation Study

Study Overview
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Brief Summary
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This study will evaluate consumer preference and consumer results from a number of commercially available home pregnancy tests. The study is being conducted as a formal assessment home pregnancy tests sold in Western Europe.

Detailed Description
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The study will be conducted in two parts: Part 1: Volunteers representative of pregnancy test users will use a range (4 of 7 different tests being evaluated) in their own home to gain usability data. All products will be used according to their instructions for use which, where required, will be translated into English prior to the study start. A study questionnaire will be completed after each test is used. Part 2: The volunteers will attend the study site soon after completing their last home test and be required to read randomised results of tests conducted by study technicians (pregnant and not pregnant) to gain an understanding of their ability to correctly read results of the tests. The technician will also read and record the test results to enable both the laboratory agreement (technician read) and the consumer readability to be determined and compared for each product. Each volunteer will be required to provide a urine sample for determining pregnancy status and quantitative urinary hormone measurement (this is done to confirm the result obtained at home using the HPTs). At the end of the testing period the volunteers will also be asked to rank the four products they have used in the study, based on a series of statements regarding usability and readability of the tests

Official Title
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Home Pregnancy Test Evaluation Study

Conditions
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Pregnancy Testing

Intervention / Treatment
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* Diagnostic Test: home pregnancy test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Aged 18-45 years Willing to give informed consent Willing to conduct a personal home pregnancy test and reveal their pregnancy status Exclusion Criteria: Currently or previously employed by SPD, Alere, Unipath, P&G, Abbott, or affiliates Has an immediate relative* currently or previously employed by SPD, Alere, Unipath, P&G, Abbott or affiliates Taken a hormonal preparation containing hCG in the last month, e.g. Pregnyl® Recently miscarried and yet to have 2 complete menstrual cycles before study start

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: pregnancy test<br>pregnancy tests | Diagnostic Test: home pregnancy test<br>* Each participant will use 4 different home pregnancy tests<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Demonstration of volunteer preference for a HPTs. | • The cumulative scores on a 7-point likert scale for ease of use questions on the device usability at home questionnaire, where 1 equals very good and 7 equals very poor for each attribute. | 1 week | 
| 2. Demonstration of volunteer readability of HPTs | • The cumulative scores on a 7-point likert scale for readability questions on the device readability at SPD questionnaire, where 1 equals very easy and 7 equals very difficult for each attribute. | 1 week | 
| 3. Demonstration of consumer preference for a HPT | • The ranking of each Home Pregnancy Test in order of preference | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Accuracy of reading | The per cent agreement (accuracy) between the result read by the volunteer and true result for each standard tested (i.e 0 hCG will be not pregnant and 25mIU/ml hCG will be pregnant) for each Home pregnancy test evaluated. | 1 week | 
| Agreement of reading | The agreement between volunteer home pregnancy test results and those of a technician testing the same urine standard (volunteer vs. technician test result) | 1 week |