Actively Recruiting

Early Phase 1
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
NCT05069740

Endometriosis and Microvascular Dysfunction: Role of Inflammation

Led by Penn State University · Updated on 2024-11-05

24

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Endometriosis and Microvascular Dysfunction: Role of Inflammation

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy women aged 18 to 45 years with regular menstrual cycles or using oral contraceptives
  • Women aged 18 to 45 years diagnosed with endometriosis by laparoscopy within the past 5 years
  • Use of Tylenol allowed for acute pain
  • Use of contraceptives allowed
Not Eligible

You will not qualify if you...

  • Use of nicotine-containing products such as smoking or chewing tobacco
  • Diabetes with HbA1C of 6.5% or higher
  • Blood pressure higher than 140/90
  • Taking medications that affect peripheral vascular control (e.g., insulin sensitizers, cardiovascular drugs)
  • Pregnant or breastfeeding
  • Use of illicit or recreational drugs
  • Abnormal liver function or persistent unexplained high liver enzymes
  • Skin diseases, rashes, pigmentation disorders, or known skin allergies
  • Diagnosed or suspected metabolic or cardiovascular diseases
  • Known allergy to latex or study substances including salsalate or simvastatin
  • History of gastrointestinal bleeding

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Pennsylvania State University

University Park, Pennsylvania, United States, 16801

Actively Recruiting

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Research Team

L

Lacy M Alexander, Ph.D.

CONTACT

S

Susan Slimak, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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