MedTrace Logo

Advancing Postmenopausal Preventive Therapy

NCT04103476 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2024-12-05

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg

Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • University of Southern California

    lead OTHER

Principal Investigators

  • Howard N. Hodis, MD · University of Southern California Atherosclerosis Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
59 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-13
Primary Completion
2026-10-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04103476 on ClinicalTrials.gov