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RECRUITING

First To Know Pregnancy Test - Clinical Evaluation Protocol

NCT07304531 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DEVICE Diagnostic Test

Study Locations (2)

California

  • Matrix Clinical Research Los Angeles — Los Angeles

Texas

  • ERA Health Research — Midland

Trial Details

FieldValue
Enrollment Target 1,705 participants
Start Date 2025-10-14
Est. Completion 2026-05

Sponsor

NOWDiagnostics

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07304531

The ClinicalTrials.gov registry entry for NCT07304531 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,705 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NOWDiagnostics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Pregnancy Detection appearing as the primary indexed condition, and to 1 intervention — of which Diagnostic Test is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07304531 reports 2 study locations spanning 2 distinct geographic areas — top geographies include California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07304531 about?

NCT07304531 is a clinical study titled "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 populatio...

What is the current status of trial NCT07304531?

This trial is currently recruiting. The enrollment target is 1,705 participants. The study started on 2025-10-14. Estimated completion is 2026-05.

What conditions does trial NCT07304531 study?

This clinical trial studies the following conditions: Pregnancy Detection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07304531?

The interventions under investigation include: Diagnostic Test (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07304531?

This trial is sponsored by NOWDiagnostics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07304531 being conducted?

This trial has 2 study locations across California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial