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Advancing Postmenopausal Preventive Therapy

NCT ID: NCT04103476

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-13

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atherosclerosis Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized (1:1), double-blinded, placebo-controlled trial of BZA/CE versus placebo.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Randomization randomly determined with key to treatment groups maintained by a single individual in the data coordinating center (DCC); study product masked with matching placebo.

Study Groups

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BZA/CE

Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg

Group Type EXPERIMENTAL

Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg

Intervention Type COMBINATION_PRODUCT

Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg

Placebo

Oral matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg

Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg

Intervention Type COMBINATION_PRODUCT

Placebo

Placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Howard N. Hodis, M.D.

Professor of Medicine and Preventive Medicine, Director Atherosclerosis Research Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Howard N. Hodis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California Atherosclerosis Research Unit

Locations

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University of Southern California Atherosclerosis Research Unit

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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R01AG058691

Identifier Type: NIH

Identifier Source: secondary_id

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R01AG058691

Identifier Type: NIH

Identifier Source: org_study_id

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