Impact of Estradiol on Endothelial Function in Peri-Menopausal Women
The purpose of this study is to identify the impact of estradiol (E2) on the mechanisms that regulate vascular endothelial function in peri-menopausal (PERI) women. This study is the first step in understanding factors contributing to endothelial dysfunction in women with advancing reproductive age and in response to E2 administration.
Conditions:
🦠 Perimenopause 🦠 Vasodilation 🦠 Estrogen
🗓️ Study Start (Actual) 1 October 2020
🗓️ Primary Completion (Estimated) 1 April 2025
✅ Study Completion (Estimated) 30 September 2025
👥 Enrollment (Estimated) 80
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Newark, Delaware, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Peri-menopausal women between 40-58 years of age with variable cycles as defined by increase in cycle length of greater than 7 days within ten consecutive cycles, or amenorrhea for more than 2 months, but less than 12 months.

    Exclusion Criteria:

    • * Women who are pregnant, planning on becoming pregnant, or are breast feeding;
    • * Women who have a history of cardiovascular disease, blood clots (e.g, pulmonary embolism or deep vein thrombosis), stroke, cancer, or liver disease;
    • * Women who have a body mass index less than 18 or greater than 35kg/m2;
    • * Women who use tobacco products;
    • * Women who's blood pressure is greater than 140/90 mmHg, have been diagnosed by a physician with hypertension or are taking medication for high blood pressure;
    • * Women who have a neurological disease, or diabetes;
    • * Women who have had a hysterectomy or have used hormones (birth control or hormone replacement) within the past 3 months;
    • * Women who have a latex allergy.
Ages Eligible for Study: 40 Years to 58 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 27 January 2020
  • First Submitted that Met QC Criteria 1 February 2020
  • First Posted 5 February 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 July 2024
  • Last Update Posted 3 July 2024
  • Last Verified July 2024