Advancing Postmenopausal Preventive Therapy

NCT04103476 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: R01AG058691
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atherosclerosis; Cognitive Decline

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• CCA stiffness

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

Other Outcomes (1)

• Cognitive decline

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

Study Arms (2)

BZA/CE

EXPERIMENTAL

Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg

Combination Product: Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg

Placebo

PLACEBO COMPARATOR

Oral matching placebo

Other: Placebo

Interventions

Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg COMBINATION_PRODUCT

Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg

BZA/CE

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 45 Years - 59 Years
• Gender Eligibility Details: Postmenopausal women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Southern California Atherosclerosis Research Unit

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Atherosclerosis; Cognitive Dysfunction

Interventions

bazedoxifene; Estrogens, Conjugated (USP)

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Howard N. Hodis, MD

  University of Southern California Atherosclerosis Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Preventive Medicine, Director Atherosclerosis Research Unit

Model Details: Randomized (1:1), double-blinded, placebo-controlled trial of BZA/CE versus placebo.

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 25, 2019
• Study Start: April 13, 2021
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

US (1)