Advancing Postmenopausal Preventive Therapy (APPT), a progestogen-free estrogen therapy to potentially reduce atherosclerosis: a randomized-controlled trial
Cardiovascular disease (narrowed or blocked blood vessels) is the leading cause of death, killing 1 of every 2 women. Atherosclerosis (hardening of the arteries) is the major cause of cardiovascular disease. More than 90% of deaths due to atherosclerosis occur after menopause when a women’s production of estrogen disappears. Research over the last decade has shown that estrogen provides potential cardiovascular benefits with low-risk to women. However, most women have a uterus that requires co-treatment with a progestogen (Provera, progesterone, etc.) to prevent thickening of the uterine lining due to estrogen. Compared to estrogen-alone therapy, traditional progestogen-estrogen therapy appears to have a greater health risk for women.
The goal of this study is to learn whether a new type of progestogen-free hormone therapy, one that protects the uterus differently so that estrogen can be delivered without risk from progestogen, has beneficial effects on hardening of the arteries in postmenopausal women. Participants in the study will be randomized, split into two groups, to receive either an FDA-approved medication designed to deliver estrogen without a progestogen (Bazedoxifene /estrogen) or placebo, a pill that does not contain an active ingredient.
Keywords: atherosclerosis, heart disease, menopause, women, estrogen, intervention
University of Southern California, Keck School of Medicine, Atherosclerosis Research Unit, 2250 Alcazar Street, CSC, Suite 132, Los Angeles, CA 90033
Eligibility Requirements: Postmenopausal women, 45-59 years of age, who have not had a hysterectomy and do not have heart disease or diabetes.
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2 - 3 years
18 - 24 visits. After qualifying for the study, visits take place every month for the first 6 months and then every 2 months for the remainder of participation
Bazedoxifene 20 mg/conjugated estrogen 0.45 mg
Non-invasive ultrasound scanning of the neck arteries
Blood pressure measurements
Blood chemistries and cell counts
Cognitive (memory, thinking, mental function) testing
Study-related tests are covered
- 45-59 years of age
- Heart disease
About This Study
To conduct a double-blinded, placebo-controlled trial to determine the effects of tissue selective estrogen complex (TSEC) therapy on the progression of subclinical atherosclerosis in healthy postmenopausal women who have not had a hysterectomy. A total of 360 women 45-59 years of age without clinical cardiovascular disease and diabetes mellitus will be randomized to Bazedoxifene/conjugated estrogen (BZA 20 mg/CE 0.45 mg) or placebo. Randomized treatment will be 2 to 3 years. Atherosclerosis, measured non-invasively as rate of change in carotid artery intima-media thickness (CIMT) in computer image processed B‑mode ultrasonograms, will be the primary trial endpoint. Three composite cognitive measures will be used to test for randomized treatment group differences in cognition; each composite will be considered as co-endpoints.
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