Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)
NCT02237079 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2023-06-26
Summary
The goal of this pilot clinical study is to perform a randomized placebo-controlled study to assess the beneficial effect of a 3 month-treatment with Bazedoxifene/Conjugated Estrogens (BZA/CE) vs. placebo on glucose homeostasis and body composition in 20 post-menopausal women. The recruitment will be performed at Tulane Health Sciences Center.
Conditions
- Obesity
- Glucose Homeostasis
- Postmenopausal Symptoms
Interventions
- DRUG
-
Bazedoxifene/Conjugated Estrogens (BZA/CE)
Daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
- DRUG
-
Placebo Oral Tablet
Daily placebo tablet
Sponsors & Collaborators
-
Tulane University Health Sciences Center
lead OTHER
Principal Investigators
-
Franck Mauvais-Jarvis, MD · Tulane University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 60 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-12-31
- Primary Completion
- 2018-04-30
- Completion
- 2018-04-30
Countries
- United States
Study Locations
More Related Trials
-
Study Of Pharmacokinetic (PK) Profile of Bazedoxifene (BZA) in 2 BZA/Conjugated Estrogen Forms
NCT00479778 ·Status: COMPLETED ·Phase: PHASE1
-
A Pilot Bioavailability Study of 3 Test Tablet Formulations of Bazedoxifene Compared With A Reference Tablet Formulation of Bazedoxifene/Conjugated Estrogens in Healthy Postmenopausal Women
NCT01634789 ·Status: TERMINATED ·Phase: PHASE1
-
Pilot Study of Bazedoxifene Plus Conjugated Estrogen on Imaging and Blood Biomarkers
NCT04821375 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Study Comparing Formulations of Bazedoxifene/Conjugated Estrogens
NCT00550303 ·Status: COMPLETED ·Phase: PHASE1
-
Study Evaluating Premarin and Bazedoxifene Potential Interaction
NCT00745173 ·Status: COMPLETED ·Phase: PHASE1
-
Study Evaluating Bazedoxifene/CE in Postmenopausal Women
NCT00550433 ·Status: COMPLETED ·Phase: PHASE1
-
Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women
NCT00242710 ·Status: COMPLETED ·Phase: PHASE3
-
Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause
NCT00238732 ·Status: COMPLETED ·Phase: PHASE3
-
Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In Postmenopausal Women
NCT00396799 ·Status: COMPLETED ·Phase: PHASE1
-
Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Symptoms Associated With Menopause
NCT00234819 ·Status: COMPLETED ·Phase: PHASE3
-
Study Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women
NCT00675688 ·Status: COMPLETED ·Phase: PHASE3
-
Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis
NCT00808132 ·Status: COMPLETED ·Phase: PHASE3
-
The Interaction Between Diabetes and Estradiol on Human Brain Metabolism in Postmenopausal Women
NCT03681691 ·Status: COMPLETED ·Phase: PHASE1
-
Study Evaluating Changes In Mammographic Breast Density
NCT00774267 ·Status: COMPLETED
-
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
NCT04821141 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Comparison Between Raloxifene and Bazedoxifene
NCT01973738 ·Status: UNKNOWN
-
A New Hormone Replacement Paradigm: Physiologic Restoration Study
NCT04190927 ·Status: UNKNOWN ·Phase: PHASE4
-
Effects of a Seven-day BASIS™ Supplementation on Menopausal Syndromes and Measurements of the Urinary Vitamin B3 and Estradiol Levels in Pre-, Peri- and Post-menopause
NCT04841499 ·Status: COMPLETED ·Phase: NA
-
Bioidentical 'Natural' Hormone Evaluation in Early Menopause
NCT00302731 ·Status: TERMINATED ·Phase: PHASE2
-
Prevention of Obesity in Women Via Estradiol Regulation
NCT00687739 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Effect of Estrogen on Estrogen Receptor Biomarkers in Healthy Postmenopausal Women (0000-094)(COMPLETED)
NCT00799708 ·Status: COMPLETED ·Phase: PHASE1
-
Bioenergetic Effects of Aging and Menopause (BEAM)
NCT04043520 ·Status: RECRUITING ·Phase: PHASE4
-
Chronic Effects of Estrogen in Microcirculation
NCT01295892 ·Status: COMPLETED ·Phase: PHASE4
-
Impact of Estrogen + Estradiol Receptor Alpha Modulator Therapy on Oxidative Stress in Post-menopausal Women With and Without Sleep Apnea
NCT03981341 ·Status: UNKNOWN ·Phase: PHASE3
-
Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women
NCT00592839 ·Status: COMPLETED ·Phase: PHASE4