Advancing Postmenopausal Preventive Therapy

Phase 2Active Not RecruitingNCT04103476

University of Southern California385 enrolled

Overview

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.

To conduct a double-blinded, placebo-controlled trial to determine the effects of TSEC therapy on the progression of subclinical atherosclerosis in healthy postmenopausal women. A total of 360 postmenopausal women with a uterus who are within 6 years of menopause and 45-59 years of age and without clinical cardiovascular disease and diabetes mellitus will be randomized to Bazedoxifene/Conjugated Equine Estrogen (BZA 20 mg/CE 0.45 mg) or placebo. Recruitment will occur over 3 years and the treatment period will be up to 3 years depending on when an individual is randomized. Rate of change in carotid artery intima-media thickness (CIMT) determined from the distal common carotid artery (CCA) far wall intima-media thickness (IMT) in computer image processed B mode ultrasonograms will be the primary trial endpoint. Arterial stiffness measured from the CCA (same location as CIMT) in computer image processed B mode ultrasonograms will be the secondary 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

385

Conditions

Atherosclerosis Cognitive Decline

Interventions

Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mgCOMBINATION_PRODUCT

Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg

PlaceboOTHER

Placebo

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Women with a serum estradiol level \<30 pg/ml and cessation of regular menses \>6 months who are \<6 years postmenopausal and 45-59 years old. Exclusion Criteria: * Women with a hysterectomy * Clinical signs, symptoms or personal history of cardiovascular disease * Diabetes mellitus or fasting serum glucose \>126 mg/dL * Life threatening illness with prognosis \<5 years * Cirrhosis or liver disease * History of deep vein thrombosis or pulmonary embolism * History of breast cancer * Current use of postmenopausal hormone replacement therapy (HRT) within 1 month of randomization * Uncontrolled hypertension (\>180/\>110 mmHg)\* * Plasma triglyceride levels \>500 mg/dL * Serum creatinine \>2.0 mg/dL

Locations (1)

University of Southern California Atherosclerosis Research Unit

Los Angeles, California, United States

Outcomes

Primary Outcomes

Carotid artery intima-media thickness

Rate of change in carotid artery intima-media thickness (CIMT) determined from the distal common carotid artery (CCA) far wall intima-media thickness (IMT) in computer image processed B mode ultrasonograms.

Time frame: At baseline and 6 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after randomization

Secondary Outcomes

CCA stiffness

Arterial stiffness measured from the CCA (same location as CIMT) in computer image processed B mode ultrasonograms.

Time frame: At baseline and 6 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after randomization

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.