NCT04103476

Advancing Postmenopausal Preventive Therapy

Atherosclerosis Intervention With Novel Tissue Selective Estrogen Complex Therapy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 385 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Female
• Age: 45 Years – 59 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

• Atherosclerosis
• Cognitive Decline

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg	Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg
OTHER	Placebo	Placebo

Timeline

• Start date: 2021-04-13
• Primary completion: 2026-10-31
• Completion: 2026-12-31
• First posted: 2019-09-25
• Last updated: 2024-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study