Advancing Postmenopausal Preventive Therapy (APPT)

University of Southern California

Status and phase: Active, not recruiting; Phase 2

Conditions: Cognitive Decline; Atherosclerosis

Treatments: Other: Placebo; Combination Product: Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04103476

R01AG058691 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 385 patients

Sex: Female

Ages: 45 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

385 participants in 2 patient groups, including a placebo group

BZA/CE

Experimental group

Description:

Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg

Treatment:

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

Placebo

Placebo Comparator group

Description:

Oral matching placebo

Treatment:

Other: Placebo