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Advancing Postmenopausal Preventive Therapy
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.
Conditions:
🦠 Atherosclerosis 🦠 Cognitive Decline
🗓️ Study Start (Actual) 13 April 2021
🗓️ Primary Completion (Estimated) 31 October 2026
✅ Study Completion (Estimated) 31 December 2026
👥 Enrollment (Estimated) 400
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Los Angeles, California, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 45 Years to 59 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 September 2019
  • First Submitted that Met QC Criteria 23 September 2019
  • First Posted 25 September 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 November 2023
  • Last Update Posted 24 November 2023
  • Last Verified November 2023
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