Multiple clinical trials investigate the health effects and exposure dynamics of Bisphenol A, encompassing observational and interventional protocols across Phase 1, Phase 4, and non-applicable frameworks. Primarily sponsored by academic institutions and university hospitals, these completed, recruiting, terminated, or withdrawn studies evaluate conditions including type 2 diabetes, triple-negative breast cancer, male and female reproductive disorders, hypogonadism, autoimmune thyroid disease, and environmental exposure risks. Recent research emphasizes clinical priorities in exposure mitigation, dietary interventions, and biomonitoring across affected populations.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT03771066 | COMPLETED | Insulin Sensitivity; Glucose Metabolism Disorders; Microtia |
California Polytechnic State University-San Luis Obispo |
2019-01-01 | |
| NCT05746130 | COMPLETED | Adolescent Behavior; Bisphenol A; Urine |
Akdeniz University |
2023-03-16 | |
| NCT05177250 | UNKNOWN | Type2 Diabetes; Bisphenol A |
Cairo University |
2022-02-20 | |
| NCT04268693 | Withdrawn | Triple Negative Breast Cancer |
George Washington University |
2022-09 | -- |
| NCT05454085 | COMPLETED | Neural Tube Defects; Bisphenol-A |
Sanliurfa Mehmet Akif Inan Education and Research Hospital |
2021-04-15 | |
| NCT04788810 | UNKNOWN | Pharmacokinetic Study |
Poitiers University Hospital |
2021-03-01 | |
| NCT05177250 | Recruiting | Type2 Diabetes|Bisphenol A |
Cairo University |
2022-02-20 | Not Applicable |
| NCT05205837 | Terminated | Hypogonadism|Hypogonadism Male|Hypogonadotropic Hypogonadism |
Rigshospitalet Denmark |
2021-11-24 | Phase 4 |
| NCT01573429 | COMPLETED | Healthy Volunteers |
National Institute of Environmental Health Sciences (NIEHS) |
2012-07-18 | PHASE1 |
| NCT05224284 | COMPLETED | Infertility, Male; IVF |
Sanliurfa Mehmet Akif Inan Education and Research Hospital |
2019-05-01 | |
| NCT02377219 | TERMINATED | Female Reproductive Problem; Male Reproductive Problems |
University Hospital, Toulouse |
2014-10 | |
| NCT03440307 | COMPLETED | Environmental Exposure |
California Polytechnic State University-San Luis Obispo |
2015-11-12 | |
| NCT02096991 | COMPLETED | Hypertension |
Seoul National University Hospital |
2014-02 |
(data from https://clinicaltrials.gov, updated on 2024-07-08)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).