Endometriosis and Microvascular Dysfunction: Role of Inflammation
The purpose of this study is to better understand the underlying mechanisms associated with elevated cardiovascular disease risk in women with endometriosis, and to measure the effectiveness of emerging endometriosis treatments on outcomes specific to cardiovascular dysfunction. Epidemiologic data demonstrate a clear association between endometriosis, reproductive risk factors, inflammation and cardiovascular (CV) risk. Circulating factors, low-density lipoprotein (LDL) and oxidized LDL (oxLDL), are two of many biomarkers of cardiovascular and inflammatory disease of endometriosis. An important signaling mechanism through which circulating LDL and oxLDL act is the lectin-like oxidized LDL receptor (LOX-1). LOX-1 signal transduction functionally results in pronounced endothelial dysfunction, a hallmark of CV. The investigators hypothesis that one factor mediating the elevated risk of cardiovascular disease in endometriosis is systemic inflammation and activation of LOX-1 receptor mechanisms.
Conditions:
🦠 Endometriosis
🗓️ Study Start (Actual) 1 February 2022
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 31 December 2026
👥 Enrollment (Estimated) 24
🔬 Study Type INTERVENTIONAL
📊 Phase EARLY_PHASE1
Locations:
📍 University Park, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Healthy women between the ages of 18 and 45 years (Controls), taking oral contraceptive or with regular menses every 26-34 days
    • * Women between the ages of 18 and 45 years with endometriosis (diagnosis by prior laparoscopy by subject's own physician \<5 years prior, and reported by the subject to the researchers)
    • * Tylenol if the subject has acute pain is allowed
    • * Contraceptive use is allowed

    Exclusion Criteria:

    • * Use of nicotine-containing products (e.g. smoking, chewing tobacco, etc.)
    • * Diabetes (HbA1C 6.5%)
    • * BP\>140/90
    • * Taking pharmacotherapy that could alter peripheral vascular control (e.g. insulin sensitizing, cardiovascular medications)
    • * Pregnancy
    • * Breastfeeding
    • * Taking illicit and/or recreational drugs
    • * Abnormal liver function
    • * Rash, skin disease, disorders of pigmentation, known skin allergies
    • * Diagnosed or suspected metabolic or cardiovascular disease
    • * Persistent unexplained elevations of serum transaminases
    • * Known allergy to latex or investigative substances (including salsalate or simvastatin)
    • * History of gastrointestinal bleeding
Ages Eligible for Study: 18 Years to 45 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 10 September 2021
  • First Submitted that Met QC Criteria 24 September 2021
  • First Posted 6 October 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 February 2024
  • Last Update Posted 7 February 2024
  • Last Verified February 2024