Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee
Purpose: To determine the effects of SERM and simvastatin interventions on endothelial dysfunction in women with endometriosis. Hypothesis: Treatment with the SERM (bazedoxifene + conjugated estrogen) or with simvastatin will decrease systemic inflammation and improve specific measures of cardiovascular function including endothelium-dependent vasodilation.
Conditions:
🦠 Endometriosis
🗓️ Study Start (Actual) 1 December 2023
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 31 December 2026
👥 Enrollment (Estimated) 28
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 New Haven, Connecticut, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Women between the ages of 18 and 45 years with endometriosis (diagnosis by prior laparoscopy by subject's own physician \<10 years prior, and reported by the subject to the researchers)
    • * Tylenol if the subject has acute pain is allowed
    • * IUD contraceptive use (copper or levonogestrel) 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
Ages Eligible for Study: 18 Years to 45 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ 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 20 September 2021
  • First Posted 28 September 2021

Study Record Updates

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