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Predicate and Lay User-HCP Comparison Study of a Multi-Level Urine hCG Pregnancy Test
Sponsor: Conceptra Biosciences, LLC
Summary
Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial center and provide a sample of urine from the same void for further testing. Volunteers will then complete a product usage questionnaire and leaflet comprehension questionnaire at site.
Official title: A Candidate - Predicate Comparison and Lay User-HCP Comparison Study of the Clara(TM) Multi-Level Urine hCG Pregnancy Test
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
180
Start Date
2026-06-30
Completion Date
2027-12-31
Last Updated
2026-03-19
Healthy Volunteers
Yes
Conditions
Interventions
Clara Pregnancy Test
Multi-Level Pregnancy Test
Professional Marketed Pregnancy Test
Early Pregnancy Test
Locations (1)
FPA Women's Health
Los Angeles, California, United States