First To Know Pregnancy Test - Clinical Evaluation Protocol
Public ClinicalTrials.gov record NCT07304531. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
First To Know Pregnancy Test Clinical Evaluation Protocol
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07304531
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 892 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 14 Years and older
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 13, 2025
- Primary completion
- May 6, 2026
- Completion
- May 6, 2026
- Last update posted
- Sep 7, 2026
2025 – 2026
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Matrix Clinical Research Los Angeles | Los Angeles | California | 90057 | — |
| ERA Health Research | Midland | Texas | 79707 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07304531, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 7, 2026 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07304531 live on ClinicalTrials.gov.