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Bisphenol A Controlled Exposure Study

NCT01573429 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-11-18

No results posted yet for this study

Summary

Background:

\- Bisphenol A (BPA) is a chemical that is used primarily to make plastics, resins, and thermal paper. Most people are exposed daily to low levels of BPA that leaches into food and water from plastic products, including water and baby bottles. However, not all of the risks of BPA are known. Researchers want to learn more about how BPA acts in the body, and how the body gets rid of BPA.

Objectives:

\- To study controlled exposure to BPA and its effects on the body.

Eligibility:

\- Healthy, non-obese volunteers between 25 and 45 years of age.

Design:

* Participants will have six visits over about 2 to 4 weeks for this study.
* At the first visit, participants will be screened with a physical exam and blood and urine tests. They will complete a questionnaire about exposure to BPA-containing products. They will also receive a list of medications that should not be taken during the study period.
* The second visit will last about 13 hours. Participants will fast for 8 hours before the visit. They will then have a single dose of d-BPA (a modified form of BPA that is easier to study in the body). Regular blood samples will be taken over the 13-hour visit. All urine will also be collected. Participants will receive breakfast and lunch during the visit.
* Participants will have four follow-up visits. They will collect and store all of their urine between each follow-up visit. Blood samples will be collected at the follow-up visits....

Conditions

  • Healthy Volunteers

Interventions

OTHER

deuterated-Bisphenol A (d-BPA)

The primary endpoints are key pharmacokinetic measurements of d-BPA and d-BPA conjugates in blood and urine over 6 days after a single dose of oral and/or ethanol solution dermal application and/or a carboxymethylcellulose suspension dermal application of a dose of 100 micro g/kg bw of d-BPA.

Sponsors & Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

    lead NIH

Principal Investigators

  • Stavros Garantziotis, M.D. · National Institute of Environmental Health Sciences (NIEHS)

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-18
Primary Completion
2020-06-16
Completion
2020-06-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01573429 on ClinicalTrials.gov