Atherosclerosis Intervention With Novel Tissue Selective Estrogen Complex Therapy

R01AG058691

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.

2021-04-13

2026-10-31

2026-12-31

Recruiting

Early phase I

400

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized (1:1), double-blinded, placebo-controlled trial of BZA/CE versus placebo.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 400, 'type': 'ESTIMATED'}}

2023-11-24