Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01573429 · ClinicalTrials.gov registry record · Phase 1
Bisphenol A Controlled Exposure Study
A Phase 1 study, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT01573429: Completed Phase 1 study, sponsored by National Institute of Environmental Health Sciences (NIEHS).
NCT01573429 is a Phase 1 study that has completed, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01573429, a Phase 1 study, has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
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....
Primary Outcome
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 acarboxymethylcellulose suspension dermal application of a dose of 100 micro g/kg bw of d-BPA.
Interventions
- OTHER deuterated-Bisphenol A (d-BPA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2012-07-18 |
| Est. Completion | 2020-06-16 |
| Phase | Phase 1 |
What the finished NCT01573429 record still lists
NCT01573429 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 1 intervention - of which deuterated-Bisphenol A (d-BPA) is the first listed.
NCT01573429 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01573429 about?
NCT01573429 is a clinical study titled "Bisphenol A Controlled Exposure Study". 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 kn...
What is the current status of trial NCT01573429?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2012-07-18. Estimated completion is 2020-06-16.
What interventions are being tested in trial NCT01573429?
The interventions under investigation include: deuterated-Bisphenol A (d-BPA) (OTHER).
Who is sponsoring clinical trial NCT01573429?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01573429's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01684904 · 38 participants · NA
Proton Therapy for Esophageal Cancer
- NCT03310879 · 38 participants · Phase 2
Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-Type Cyclins or Amplification of CDK4 or CDK6
- NCT03896269 · 38 participants · Phase 1
CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
- NCT04085315 · 38 participants · Phase 1
Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI