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Endometriosis and Microvascular Dysfunction: Role of Inflammation

Study acronym: Endo3/SA2
StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2025 → Dec 31, 2026
See other at-risk trials from Penn State University

Record History

  1. Notable Primary completion pushed from Dec 31, 2025 to Dec 31, 2026v8
  2. Minor Start date: Feb 1, 2022 to Jan 1, 2022v7
  3. Minor Start date: Jan 1, 2023 to Feb 1, 2022v6
  4. Notable Start date: Jan 1, 2022 to Jan 1, 2023v5
  5. Notable Enrollment target: 40 to 24v4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting Study site revisedv3 Show 1 more changeShow less
  2. Notable Primary endpoints revised (4)v2 See this version in full on ClinicalTrials.gov ↗
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05069740
Lead Sponsor Penn State University
Conditions Endometriosis
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov