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Endometriosis and Microvascular Dysfunction: Role of Inflammation

NCT05069740 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-11-05

No results posted yet for this study

Summary

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

Interventions

DRUG

Salsalate Pill

Salsalate acts as an NFkB inhibitor to reduce systemic inflammation

DRUG

Placebo

Placebo for the salsalate intervention

Sponsors & Collaborators

  • Penn State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2025-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05069740 on ClinicalTrials.gov