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

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tulane University Health Sciences Center
• Treatments: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)

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)