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Tissue Selective Estrogen Complex

Bazedoxifene + Estrogens for Atherosclerosis (APPT Trial)

Phase 2
Recruiting
Led By Howard N. Hodis, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Clinical signs, symptoms or personal history of cardiovascular disease
Life threatening illness with prognosis <5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and 6 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after randomization
Awards & highlights

Summary

This trial is designed to test the effects of a tissue selective estrogen complex on the progression of subclinical atherosclerosis and cognitive decline in 360 postmenopausal women.

Who is the study for?
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.
What is being tested?
The APPT study tests if a combo pill (bazedoxifene and conjugated estrogens) can slow down heart artery hardening and mental decline compared to a placebo. The trial randomly assigns participants to either the treatment or placebo group in secret.
What are the potential side effects?
Possible side effects include typical symptoms associated with estrogen therapy such as nausea, headaches, swelling due to fluid retention and potential increased risk of blood clots.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of heart problems.
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My doctor expects I have less than 5 years to live due to my illness.
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I have had breast cancer in the past.
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My blood pressure is not higher than 180/110 mmHg.
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I have had a deep vein thrombosis or pulmonary embolism.
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I have cirrhosis or another liver disease.
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I have diabetes or my blood sugar level is high.
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I have had a hysterectomy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and 6 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and 6 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Carotid Arteries
Secondary study objectives
CCA stiffness
Other study objectives
Cognitive decline

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BZA/CEExperimental Treatment1 Intervention
Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg
Group II: PlaceboPlacebo Group1 Intervention
Oral matching placebo

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,603 Total Patients Enrolled
16 Trials studying Atherosclerosis
30,896 Patients Enrolled for Atherosclerosis
University of Southern CaliforniaLead Sponsor
936 Previous Clinical Trials
1,613,081 Total Patients Enrolled
8 Trials studying Atherosclerosis
1,543 Patients Enrolled for Atherosclerosis
Howard N. Hodis, MDPrincipal Investigator - University of Southern California Atherosclerosis Research Unit
University of Southern California
8 Previous Clinical Trials
2,764 Total Patients Enrolled
8 Trials studying Atherosclerosis
2,764 Patients Enrolled for Atherosclerosis

Media Library

Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg (Tissue Selective Estrogen Complex) Clinical Trial Eligibility Overview. Trial Name: NCT04103476 — Phase 2
Atherosclerosis Research Study Groups: Placebo, BZA/CE
Atherosclerosis Clinical Trial 2023: Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg Highlights & Side Effects. Trial Name: NCT04103476 — Phase 2
Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg (Tissue Selective Estrogen Complex) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04103476 — Phase 2
~152 spots leftby Oct 2026
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