RecruitingNot Applicable

First To Know Pregnancy Test - Clinical Evaluation Protocol

United States1,705 participantsStarted 2025-10-14

Plain-language 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.

Who can participate

Age range

14 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 - 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 Criteria: * 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluate the accuracy and sensitivity of the First To Know Pregnancy test compared to a legally marketed quantitative blood-based hCG assay

Timeframe: Through study completion, an average of 6 months

Trial details

NCT IDNCT07304531

SponsorNOWDiagnostics, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-04

Contact for this trial

Monica Healy

240-498-3933 mhealy@mcra.com

View on ClinicalTrials.gov More Pregnancy Detection trials