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

Pregnancy Detection

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

Inclusion Criteria11

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 - Peri-menopausal: ≥41 years of age and ≤ 54 years of age
Cohort A3 - Post-menopausal: ≥55 years of age
Not menstruating at the time of the initial study visit
Must be willing to complete all study activities, provide all specimens/samples, and conduct all required testing
Willing to provide information regarding the diagnosis of pregnancy or details from their standard of care follow-up visit after initial visit
Sexually active
Not using contraceptives
English/Spanish speaking

Exclusion Criteria8

Males
Females \<14 years of age
Recent pregnancy within the past 6 months
Trophoblastic disease or non-trophoblastic neoplasms
Downs syndrome (trisomy 21)
People with limited or no reading skills
Amenorrhea not related to peri or post menopause
Use of medications or hormonal contraceptives that may interfere with hCG levels at the time of testing (e.g., Gonadotropins: Luteinizing hormone)

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

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NCT07304531