Status:
COMPLETED
Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)
Lead Sponsor:
Tulane University Health Sciences Center
Conditions:
Obesity
Glucose Homeostasis
Eligibility:
FEMALE
50-60 years
Phase:
PHASE4
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. pla...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02237079
Start Date
December 1 2014
End Date
April 1 2018
Last Update
June 26 2023
Active Locations (1)
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1
Tulane University Clinical Translational Unit
New Orleans, Louisiana, United States, 70112