Advancing Postmenopausal Preventive Therapy (APPT)

Objetivo

To conduct a double-blinded, placebo-controlled trial to determine the effects of tissue selective estrogen complex (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. Randomized treatment will be 2 to 3 years. 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.

To determine the effect of a new form of hormone replacement therapy that does not contain progestin or progesterone for postmenopausal women with a uterus on hardening of the arteries (atherosclerosis), the major underlying cause of heart disease and stroke. 

Palabras clave: atherosclerosis, heart disease, stroke, menopause, women, estrogen, intervention

Sitios de estudio

University of Southern California, Keck School of Medicine, Atherosclerosis Research Unit, 2250 Alcazar Street, CSC, Suite 132, Los Angeles, CA 90033

 
  • Women
Age icon
45 - 59
 
 

323-442-2257

8:30 AM - 5:00 PM

aru.usc.edu

O
 

¿Qué hay involucrado?

Duración del ensayo
  • 2 - 3 years

Número de visitas
  • 18 - 24 visits

Prescripción
  • Bazedoxifene/conjugated estrogens

  • Placebo

Procedimiento
  • Pap smear

  • Non-invasive ultrasound scanning of the neck arteries

  • Blood pressure measurements

  • Mammogram

  • Cholesterol measurements

  • Blood chemistries and cell counts

  • Cognitive (memory, thinking, mental function) testing

  • Electrocardiograms (EKGs)

  • Pelvic examination

Compensation
  • none

Cobertura de gastos médicos
  • study-related tests are covered

Why participate?

Los avances médicos son imposibles sin voluntarios.

Equipo del Programa

Photohandler
Investigador Principal
Howard Neil Hodis, MD

For questions about this study, contact:

  • Dr. Howard N Hodis
  • Atherosclerosis Research Unit, 2250 Alcazar Street, Suite 132, Los Angeles, CA 90033
  • 323-442-2257
  • APPT@usc.edu

Research study materials

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