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

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

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.

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)