Clinical Trials

Numerous clinical trials, ranging from early-phase pharmacokinetic evaluations to Phase 4 studies, evaluate bazedoxifene acetate primarily for postmenopausal osteoporosis, vaginal atrophy, and menopausal symptoms, alongside exploratory investigations in breast cancer and relapsing-remitting multiple sclerosis. Sponsored by pharmaceutical companies such as Pfizer and Wyeth as well as academic institutions like Laval University and the University of Kansas Medical Center, these trials encompass completed, active, recruiting, terminated, and withdrawn recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04113993 RECRUITING
Schizophrenia; Schizophreniform Disorders; Schizo Affective Disorder
The Alfred
 2019-10-07 PHASE4
NCT05059626 ENROLLING_BY_INVITATION
Endometriosis
Penn State University
 2023-12-01 PHASE4
NCT04103476 ACTIVE_NOT_RECRUITING
Atherosclerosis; Cognitive Decline
University of Southern California
 2021-04-13 PHASE2
NCT04821141 ACTIVE_NOT_RECRUITING
Risk Reduction; Breast Cancer
University of Kansas Medical Center
 2021-12-14 PHASE2
NCT04478305 RECRUITING
Menopause; Depression, Anxiety; Sleep; Menopause Related Conditions
St. Joseph's Healthcare Hamilton
 2024-07-03 PHASE1
NCT04002934 COMPLETED
Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
Riley Bove, MD
 2019-09-10 PHASE2
NCT02694809 COMPLETED
Ductal Breast Carcinoma In Situ; Postmenopausal
Northwestern University
 2017-01 PHASE2
NCT04821375 COMPLETED
Increased Risk for Development of Breast Cancer
Carol Fabian, MD
 2021-12-02 EARLY_PHASE1
NCT05073237 WITHDRAWN
Menopause; Prediabetes; Obesity
VA Office of Research and Development
 2024-04-08 PHASE2
NCT04812808 UNKNOWN
Pancreas Cancer
Hôpital Fribourgeois
 2022-02-01
NCT03981341 UNKNOWN
Sleep Apnea; Post Menopausal; Oxidative Stress
Laval University
 2019-11-01 PHASE3
NCT04036929 COMPLETED
Hand Osteoarthritis
University of Oxford
 2019-05-09
NCT03740009 COMPLETED
Perimenopausal Disorder; Depression
University of North Carolina, Chapel Hill
 2019-01-02 PHASE4
NCT02448771 COMPLETED
Breast Cancer Stage IV; Unresectable Locally Advanced Invasive Breast Cancer; Metastatic Invasive Breast Cancer
Dana-Farber Cancer Institute
 2015-07-09 PHASE1; PHASE2
NCT02237079 COMPLETED
Obesity; Glucose Homeostasis; Postmenopausal Symptoms
Tulane University Health Sciences Center
 2014-12 PHASE4
NCT03475719 Unknown status
Osteoporosis Postmenopausal
Huons Co. Ltd.
 2018-01-11 Phase 1
NCT03382314 COMPLETED
Osteoporosis
Hyundai Pharmaceutical Co., LTD.
 2017-10-16 PHASE1
NCT02602704 COMPLETED
Arthritis, Rheumatoid
Hanyang University
 2015-12-29 PHASE4
NCT03321318 UNKNOWN
Healthy
Alvogen Korea
 2017-07-13 PHASE1
NCT03234244 COMPLETED
Osteoporosis
Hyundai Pharmaceutical Co., LTD.
 2017-04-12 PHASE1
NCT03005340 Unknown status
Healthy
Alvogen Korea
 2016-12 Phase 1
NCT02729701 Completed
Breast Cancer
University of Kansas Medical Center|Pfizer
 2016-05 Phase 2
NCT02090400 COMPLETED
Osteoporosis, Postmenopausal
Instituto Palacios
 2013-05 PHASE4
NCT02100553 COMPLETED
Healthy
Pfizer
 2014-04 PHASE1
NCT01634789 TERMINATED
Healthy
Pfizer
 2012-08 PHASE1
NCT01973738 Unknown status
Selective Estrogen Receptor Modulator
Toshihiko Kono|Tomidahama Hospital
 2012-01 --
NCT00808132 COMPLETED
Menopause; Osteoporosis
Pfizer
 2009-01 PHASE3
NCT00205777 COMPLETED
Osteoporosis
Pfizer
 2001-12 PHASE3
NCT00745173 COMPLETED
Postmenopause
Wyeth is now a wholly owned subsidiary of Pfizer
 2008-09 PHASE1
NCT00242710 COMPLETED
Endometrial Hyperplasia; Osteoporosis
Pfizer
 2005-09 PHASE3
NCT00706225 COMPLETED
Postmenopause
Wyeth is now a wholly owned subsidiary of Pfizer
 2008-06 PHASE1
NCT00675688 COMPLETED
Endometrial Hyperplasia; Osteoporosis
Wyeth is now a wholly owned subsidiary of Pfizer
 2002-04 PHASE3
NCT00481169 COMPLETED
Osteoporosis
Wyeth is now a wholly owned subsidiary of Pfizer
 2001-07 PHASE3
NCT00238745 COMPLETED
Postmenopausal Osteoporosis
Wyeth is now a wholly owned subsidiary of Pfizer
 2003-08 PHASE2
NCT00238732 COMPLETED
Vaginal Atrophy
Wyeth is now a wholly owned subsidiary of Pfizer
 2005-10 PHASE3
NCT00384072 COMPLETED
Postmenopause; Osteoporosis
Wyeth is now a wholly owned subsidiary of Pfizer
 2006-05 PHASE3
NCT00367536 COMPLETED
Postmenopause
Wyeth is now a wholly owned subsidiary of Pfizer
 2006-08 PHASE1
NCT00465075 COMPLETED
Healthy
Wyeth is now a wholly owned subsidiary of Pfizer
 2007-03 PHASE1
NCT00234819 COMPLETED
Vasomotor Symptoms Associated With Menopause
Wyeth is now a wholly owned subsidiary of Pfizer
 2005-10 PHASE3
NCT00464789 COMPLETED
Menopause
Wyeth is now a wholly owned subsidiary of Pfizer
 2007-03 PHASE1
NCT00396799 COMPLETED
Menopause
Wyeth is now a wholly owned subsidiary of Pfizer
 2006-11 PHASE1
NCT00479778 COMPLETED
Postmenopause
Wyeth is now a wholly owned subsidiary of Pfizer
 2007-04 PHASE1
NCT00550433 COMPLETED
Postmenopause
Wyeth is now a wholly owned subsidiary of Pfizer
 2007-09 PHASE1
NCT00550303 COMPLETED
Healthy
Wyeth is now a wholly owned subsidiary of Pfizer
 2007-10 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-06-03)

Check the Bazedoxifene acetate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bazedoxifene acetate functions as a selective estrogen receptor modulator that competitively binds to estrogen receptors, altering receptor conformation and selectively modulating downstream estrogen-responsive target gene transcription. This tissue-specific transcriptional activity produces estrogen receptor antagonism in breast tissue while exerting agonist effects in bone, inhibiting osteoclast-mediated resorption to support clinical applications in postmenopausal osteoporosis and breast cancer.

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>).

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Note: Technical data last updated: Sep 1, 2026.