First To Know Pregnancy Test - Clinical Evaluation Protocol
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)
| Condition(s) | Pregnancy Detection |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 | 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 Excl |
| Ages | 14 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | NOWDiagnostics, Inc. |
| Locations | Los Angeles, California, United States; Midland, Texas, United States |
| Start date | 2025-10-14 |
| NCT ID | NCT07304531 |
| Official listing | https://clinicaltrials.gov/study/NCT07304531 |