Actively Recruiting
First To Know Pregnancy Test - Clinical Evaluation Protocol
Led by NOWDiagnostics, Inc. · Updated on 2025-12-26
1705
Participants Needed
2
Research Sites
28 weeks
Total Duration
On this page
Sponsors
N
NOWDiagnostics, Inc.
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
First To Know Pregnancy Test - Clinical Evaluation Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants whose pregnancy status is unknown
- Age 14 to 40 years with regular menstrual cycles (25-35 days) for pre-menopausal group
- Age 41 to 54 years for peri-menopausal group
- Age 55 years or older for post-menopausal group
- Not menstruating at the initial study visit
- Willing to complete all study activities and provide specimens
- Willing to provide pregnancy diagnosis or follow-up information
- Sexually active
- Not using contraceptives
- Able to speak English or Spanish
You will not qualify if you...
- Male participants
- Females younger than 14 years
- Pregnancy within the last 6 months
- History of trophoblastic disease or non-trophoblastic tumors
- Diagnosis of Down syndrome (trisomy 21)
- Limited or no reading skills
- Amenorrhea not related to peri-menopause or post-menopause
- Use of medications or hormonal contraceptives affecting hCG levels at testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Matrix Clinical Research Los Angeles
Los Angeles, California, United States, 90057
Actively Recruiting
2
ERA Health Research
Midland, Texas, United States, 79707
Actively Recruiting
Research Team
M
Monica Healy
CONTACT
C
Crystal Casto, MS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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