RecruitingNCT07304531

First To Know Pregnancy Test - Clinical Evaluation Protocol

First To Know Pregnancy Test Clinical Evaluation Protocol


Sponsor

NOWDiagnostics, Inc.

Enrollment

1,705 participants

Start Date

Oct 14, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates how accurately a new at-home pregnancy test ("First To Know") detects pregnancy across different age groups, including pre-menopausal, peri-menopausal, and post-menopausal women. **You may be eligible if...** - You are female and your pregnancy status is currently unknown (you have not yet done a urine pregnancy test at home) - You fall into one of these age groups: pre-menopausal (14-40 years with regular cycles of 25-35 days), peri-menopausal (41-54 years), or post-menopausal (55 years or older) - You are not currently menstruating at the time of your first study visit - You are willing to complete all required study steps **You may NOT be eligible if...** - Your pregnancy status is already known - You do not meet the age or cycle criteria above Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEDiagnostic Test

For this observational trial , the Intervention of interest is the First To Know Pregnancy Test


Locations(2)

Matrix Clinical Research Los Angeles

Los Angeles, California, United States

ERA Health Research

Midland, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07304531