Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bazedoxifene/Conjugated Estrogens (BZA/CE) Participants assigned to BZA/CE will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg. BZA/CE (bazedoxifene/conjugated estrogens) tablets, 0.45 mg/20 mg are oval, biconvex, pink tablets, branded with "0.45/20" in black ink on one side. The recommended and only FDA approved dosage is one BZA/CE tablet daily, taken without regard to meals. Tablets should be swallowed whole. If a dose of BZA/CE is missed, participants will be instructed to take it as soon as remembered unless it is almost time for the next scheduled dose. They should not take two doses at the same time. The dose is one tablet per day independent of weight and fat mass. Participants will be provided with information about BZA/CE and its potential side effects and contraindications. |
Drug: Bazedoxifene/Conjugated Estrogens (BZA/CE)
Daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
Other Names:
|
| Placebo Comparator: Placebo Participants assigned to placebo will receive a daily tablet that matches the BZA/CE to maintain the blind. Placebo tablets, 0.45 mg/20 mg are oval, biconvex, pink tablets, branded with "0.45/20" in black ink on one side. Also to assure the blind is maintain, participants in the placebo group will be given the same instructions for taking the study medication.Tablets should be swallowed whole. If a dose, participants will be instructed to take it as soon as remembered unless it is almost time for the next scheduled dose. They should not take two doses at the same time. The dose is one tablet per day independent of weight and fat mass. Participants will be provided with information about BZA/CE and its potential side effects and contraindications, again to maintain the blind. |
Drug: Placebo Oral Tablet
Daily placebo tablet
|
Outcome Measures
Primary Outcome Measures
- Body composition [Change at 3 months from baseline]
Body composition will be assessed through change in body mass index (BMI), waist to hip circumference (WHR), and body composition DEXA scans conducted at baseline and at 3 months post-treatment. The change in 3 months will show if BZA/CE has any effect on decreasing abdominal fat.
- Glucose Homeostasis [Change at 3 months from baseline]
This will be assessed through a 2-hour IV Glucose Tolerance Tests conducted at baseline and 3 months. The changes in glucose and insulin levels throughout the test will determine if the body is able to process glucose normally.
Secondary Outcome Measures
- Systematic Inflammation [Change at 3 months from baseline]
Systematic inflammation will be measured through serum cytokines (Leptin, insulin, adiponectin, RBP4, LCN2, TNFa, IL6, PAI01, FGF21) taken at baseline and 3 months. The changes in these levels will provide information if BZA/CE can improve systematic inflammation.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Post-menopausal women (<5y since final menstrual period) with age between 50-60y
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Symptomatic (hot flashes, vaginal dryness) or asymptomatic
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BMI 26-45 kg/m2 (Overweight, Obesity I and Obesity II)
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Fasting glucose <125mg/dl
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Triglycerides <200mg/dl
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Normal mammogram within past 12 months
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Physician clearance
Exclusion Criteria:
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Amenorrhea from other causes (Hyperandrogenemia and anovulation)
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type 2 and type 1 diabetes
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Medications: diabetes or diabetic drugs, dyslipidemia, estrogen/progestin therapy, antidepressants and antipsychotics, antiretroviral (HIV), oral steroids, weight loss drugs
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≤ 3 month washout of birth control pill (often prescribed for postmenopausal symptoms)
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Hysterectomy (partial or complete)
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Contraindications to estrogen treatment (unusual vaginal bleeding, blot clots, hepatic disease, bleeding disorder, past/present history of breast or uterine cancer, pregnant, breastfeeding)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tulane University Clinical Translational Unit | New Orleans | Louisiana | United States | 70112 |
Sponsors and Collaborators
- Tulane University Health Sciences Center
Investigators
- Principal Investigator: Franck Mauvais-Jarvis, MD, Tulane University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WI190523