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Bisphenol A (BPA) Pharmacokinetic (PK): Controlled Exposure Study

Open for Recruitment

Study Background

Bisphenol A (BPA) Pharmacokinetic (PK): Controlled Exposure Study

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.

The study will involve five visits over 2 to 4 weeks. All visits will take place at the NIEHS Clinical Research Unit (CRU) in Research Triangle Park, North Carolina, and volunteers will be compensated for their time.

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 and will require participants to 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 three 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.

For more information on this study, please visit the Clinical Trials Study page.

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Eligibility

You may be eligible for this study if you meet the following criteria:

  • Between the ages of 25 to 45 years
  • Male or non-pregnant/not breastfeeding female
  • Willing and able to fast overnight
  • Ability to travel to the CRU
  • Male and females of reproductive age agree to use contraception to avoid conceiving a child and agree not to donate eggs or sperm for six months following their participation in the study.

What will you do?

  • Participate in five study visits at the National Institute of Environmental Health Sciences (NIEHS) Clinical Research Unit (CRU) in Research Triangle Park, NC.
  • First visit includes a review of your medical history, a physical exam, and blood and urine tests.
  • Second visit involves eating a vanilla wafer cookie which has a single dose of BPA, and remaining at the CRU for 13 hours to have frequent blood tests and urine collected.
  • Return to the CRU for three days following the BPA dose to collect additional blood and 24-hour urine collections.
  • Compensation for time and effort at the completion of the study is $445.

Why Participate?

  • Be part of a research study to help scientists at NIEHS understand how the body absorbs and gets rid of BPA after a single oral dose and how BPA is absorbed and excreted in the body over time.
  • You will have a physical exam by a physician and will be given results to your screening laboratory tests.
  • Receive compensation for your time and effort.

Study Location

Study visits are conducted at the NIEHS Clinical Research Unit located in Research Triangle Park, North Carolina

Protocol Number: 12-E-0089

Enrollment and Contact Information

For more information and to enroll in this study, please contact Aparna Purushotham at (919) 541-9839.

Principal Investigator

Shepherd H. Schurman
Shepherd H. Schurman, M.D.
Associate Medical Director, NIEHS Clinical Research Unit
Principal Investigator, EPR
Tel 919-541-7736
shepherd.schurman@nih.gov
P.O. Box 12233
Mail Drop CU-01
Durham, N.C. 27709