Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)
Tulane University Health Sciences Center
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.
The purpose of this study is to find out if a novel drug approved by the Food and Drug
Administration [Duavee™, Pfizer, Inc] for treatment of postmenopausal symptoms (vaginal
dryness and hot flashes) and prevention of osteoporosis also improves insulin sensitivity by
decreasing body fat especially in your liver.
DUAVEE™ (Conjugated Estrogens/Bazedoxifene) is a new prescription medicine that contains a
mixture of estrogen (the main female hormone made by the ovaries) and bazedoxifene, which is
FDA approved. For over 60 years, estrogens have been used as hormonal treatments to help
manage hot flashes and help prevent postmenopausal bone loss. But in the treatment of
postmenopausal women, the use of estrogens alone can increase the risk of developing cancer
of the uterus. So estrogens have been traditionally paired with a progestin to decrease the
risk of hyperplasia (the thickening of the lining of the uterus), which can be a precursor to
cancer. DUAVEE™ uses bazedoxifene, a selective estrogen receptor modulator (SERM), in place
of a progestin to help protect the uterus against thickening of the uterus that may result
from estrogens alone.
In this study, you will get either DUAVEE™ or the placebo (a "dummy pill" that may look like
medicine but contains no active medication) first and then switch to the other pill.
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