Status:
ACTIVE_NOT_RECRUITING
Advancing Postmenopausal Preventive Therapy
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Atherosclerosis
Cognitive Decline
Eligibility:
FEMALE
45-59 years
Phase:
PHASE2
Brief 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 th...
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 postmen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
385 Patients enrolled
Trial Details
Trial ID
NCT04103476
Start Date
April 13 2021
End Date
December 31 2026
Last Update
December 5 2024
Active Locations (1)
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1
University of Southern California Atherosclerosis Research Unit
Los Angeles, California, United States, 90033