First To Know Pregnancy Test - Clinical Evaluation Protocol
Recruiting
Observational Study
Pregnancy Detection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 14 and older
- Sex
- Female
- Study type
- Observational
- Participants needed
- 1,705 (estimated)
- Sponsor
- NOWDiagnostics, Inc. · Industry
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About This Trial
This study is evaluating the ADEXUSDx® hCG CLIA moderately complex, FDA-cleared test for potential over the counter (OTC) use and marketing as the First To Know® (FTK) Pregnancy test. The investigational FTK Pregnancy test will be used to assess its clinical performance in the intended use population (i.e., lay users) through self-testing in a simulated home setting.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Females whose pregnancy status is unknown (e.g., have not used urine test at home)
* Age Selection - must meet one of the following age groups:
* Cohort A1 - Pre-menopausal: ≥14 years of age and ≤ 40 years of age with menstrual cycles (cycle lengths of 25-35 days)
* Cohort A2 …
Contacts