Phase 4 N=17 Randomized Double-blind Prevention

Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)

Obesity · Glucose Homeostasis · Postmenopausal Symptoms

Bottom Line

View on ClinicalTrials.gov: NCT02237079 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2023

Primary outcome: Primary: Change in Body Mass Index — -0.2; -0.5 Kg/m^2

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Bazedoxifene/Conjugated Estrogens (BZA/CE) (Drug); Placebo Oral Tablet (Drug)
Age: Adult · 50+ yrs
Sex: Female
Sponsor: Tulane University Health Sciences Center
Primary completion: Apr 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Body Mass Index	-0.2; -0.5	—
PRIMARY Effect of CE/BZA on Body Composition Using Waist-to-hip Ratio	-0.05; 0.00	—
PRIMARY Change in Body Composition Using Dual-energy X-ray Absorptiometry (DXA)	273; -1408; 1.5; -131; -26; -178	—
PRIMARY Change in Acute Insulin Response to Glucose (AIRg)	189; -25	—
PRIMARY Change in Basal Glucose Concentration (Gb)	-5.2; 2.7	—
PRIMARY Change in Disposition Index (DI)	500; 267	—
PRIMARY Change in Insulin Sensitivity (SI) Index	-0.24; 1.35	—
PRIMARY Change in Homeostatic Model Assessment (HOMA) β-cell Function	18.5; -25.5	—
PRIMARY Change in Homeostatic Model Assessment (HOMA) Insulin Resistance (IR)	0.15; -0.01	—
PRIMARY Change in Fasting Insulin Clearance (FIC)	-3.50; -0.25	—
PRIMARY Change in Glucose-stimulated Insulin Clearance (GSIC)	-32.8; -1.85	—
SECONDARY Measure Change in Serum Biomarkers Panel 1	-1.6; 0.7; -1.7; -3.8; -1.8; 1.3	—
SECONDARY Measure Change in Serum Biomarkers Panel 2	-0.4; -4.0; -1.4; -2.5	—
SECONDARY Measure Change in Leptin:Adiponectin Ratio (LAR)	2.71; 1.55	—
SECONDARY Measure Change in Fibroblast Growth Factor-21 (FGF-21)	-134; -89	—
SECONDARY Measure Change in C-Reactive Protein (CRP)	-0.41; -0.39	—
SECONDARY Measure Change in Thiobarbituric Acid Reactive Substance (TBARS)	-1.7; -1.2	—

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.

Eligibility Criteria

Inclusion Criteria

Post-menopausal women (<5y since final menstrual period) with age between 50-60y
Symptomatic (hot flashes, vaginal dryness) or asymptomatic
BMI 26-45 kg/m2 (Overweight, Obesity I and Obesity II)
Fasting glucose <125mg/dl
Triglycerides <200mg/dl
Normal mammogram within past 12 months
Physician clearance

Exclusion Criteria

Amenorrhea from other causes (Hyperandrogenemia and anovulation)
type 2 and type 1 diabetes
Medications: diabetes or diabetic drugs, dyslipidemia, estrogen/progestin therapy, antidepressants and antipsychotics, antiretroviral (HIV), oral steroids, weight loss drugs
≤ 3 month washout of birth control pill (often prescribed for postmenopausal symptoms)
Hysterectomy (partial or complete)
Contraindications to estrogen treatment (unusual vaginal bleeding, blot clots, hepatic disease, bleeding disorder, past/present history of breast or uterine cancer, pregnant, breastfeeding)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02237079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.