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Search / Trial NCT04746014

Clearblue Pregnancy Test Lay User Usage Study

Launched by SPD DEVELOPMENT COMPANY LIMITED · Feb 4, 2021

Trial Information

Current as of August 02, 2025

Completed

Keywords

Lay User

ClinConnect Summary

The Clearblue HPT is an over the counter urine hCG visual-read test which is intended for the detection of pregnancy. This study aims to demonstrate that the pregnancy test has the required performance characteristics in lay user testing. The study will recruit a cross-section of the target pregnancy test user population, that is, women aged over 18 years representative of the intended user.

A minimum of 300 women will be required to complete the study consisting of both pregnant and not pregnant volunteers. Each volunteer will conduct the pregnancy test using their preferred sampling meth...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Female
  • Aged 18 and over
  • Interested in conducting a personal pregnancy test to determine or confirm their pregnancy status
  • Willing to reveal their pregnancy status
  • Willing to provide a blood sample
  • Willing to give informed consent
  • Exclusion Criteria:
  • Significant affiliation with SPD
  • Used the investigational pregnancy test previously
  • Qualified or trainee healthcare professional (HCP)
  • Has professional experience (in current or previous job) of using dipstick type tests or lateral flow devices
  • Confirmed to be pregnant by a healthcare professional and beyond the first trimester (defined as last menstrual period (LMP) +13 weeks)
  • Has a medical condition that means that it is not appropriate to give a blood sample

About Spd Development Company Limited

SPD Development Company Limited is a leading biopharmaceutical organization dedicated to advancing innovative therapies through rigorous clinical research. With a focus on developing novel treatments across various therapeutic areas, SPD Development emphasizes scientific excellence, patient safety, and regulatory compliance. By leveraging a collaborative approach, the company aims to expedite the delivery of transformative healthcare solutions while adhering to the highest standards of quality and ethics in clinical trials.

Locations

Cypress, California, United States

Patients applied

0 patients applied

Trial Officials

Sarah Johnson, PhD

Study Director

SPD Development Company

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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