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



Status:Completed
Conditions:Obesity Weight Loss, Postmenopausal Syndrome, Women's Studies, Endocrine
Therapuetic Areas:Endocrinology, Reproductive
Healthy:No
Age Range:50 - 60
Updated:7/8/2018
Start Date:December 2014
End Date:April 2018

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Trial Summary
Trial Overview
Inclusion Criteria
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)
We found this trial at
1
site
Tulane University Clinical Translational Unit
1430 Tulane Avenue
New Orleans, Louisiana 70112
Principal Investigator: Franck Mauvais-Jarvis, MD
Phone: 504-988-0200
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mi
from
New Orleans, LA
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