What this study is
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.
What's being tested
- Salsalate Pill
Intervention · DRUG
Salsalate acts as an NFkB inhibitor to reduce systemic inflammation
- Placebo
Intervention · DRUG
Placebo for the salsalate intervention
Study details
- Official title
- Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Endometriosis
- Sponsor
- Penn State University
- Conditions
- Endometriosis
- Enrolling
- 24 people
- Starts
- 2022-01-01
- Est. completion
- 2026-12-31
- Design
- Single-blind, randomized, crossover, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 45 YearsSex FEMALEHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThe Pennsylvania State University
University Park, Pennsylvania, United States
- Lacy M Alexander, PhD · Contact814-867-1781lma191@psu.edu
Recruiting
Study team
Sponsor
Penn State University
Study ID 18369
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.