Bazedoxifene + Estrogens for Atherosclerosis
(APPT Trial)
Trial Summary
What is the purpose of this trial?
Advancing Postmenopausal Preventive Therapy (APPT) is a randomized, double-blinded, placebo-controlled trial designed to determine the effects of tissue selective estrogen complex (TSEC) therapy on the progression of subclinical atherosclerosis and cognitive decline in 360 healthy postmenopausal women.
Will I have to stop taking my current medications?
The trial requires that you stop using postmenopausal hormone replacement therapy (HRT) at least 1 month before joining. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
What data supports the effectiveness of the drug Bazedoxifene + Estrogens for Atherosclerosis?
Research on postmenopausal monkeys shows that Bazedoxifene combined with conjugated estrogens may help reduce atherosclerosis (buildup of fats and cholesterol in artery walls) in coronary, peripheral, and cerebral arteries. Additionally, studies in postmenopausal women indicate that this combination can positively affect lipid levels, which are related to heart health.12345
Is the combination of bazedoxifene and conjugated estrogens safe for humans?
How is the drug Bazedoxifene + Estrogens unique for treating atherosclerosis?
Research Team
Howard N. Hodis, MD
Principal Investigator
University of Southern California Atherosclerosis Research Unit
Eligibility Criteria
This trial is for healthy postmenopausal women aged 45-59, within six years of menopause and with low estrogen levels. It's not for those who've had a hysterectomy, cardiovascular disease, diabetes, severe illness with short prognosis, liver disease, blood clots in veins or lungs, breast cancer history or recent hormone therapy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Bazedoxifene/Conjugated Equine Estrogen or placebo for up to 3 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor
National Institute on Aging (NIA)
Collaborator