First To Know Pregnancy Test - Clinical Evaluation Protocol
Recruiting now
Conditions studied: Pregnancy Detection
In brief
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.
Key facts
- Study ID
- NCT07304531
- Run by
- NOWDiagnostics, Inc.
- People needed
- 1705
- Starts
- 2025-10-14
- Expected to finish
- 2026-05-01
- Last updated by the study team
- 2025-12-26
Who can join
Age: 14 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Matrix Clinical Research Los Angeles — Los Angeles, California, United States (enrolling)
- ERA Health Research — Midland, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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