Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Endometriosis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 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

Locations
United States
Pennsylvania
The Pennsylvania State University
RECRUITING
University Park
Contact Information
Primary
Lacy M Alexander, Ph.D.
lma191@psu.edu
8148671781
Backup
Susan Slimak, RN
sks31@psu.edu
814-863-8554
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 24
Treatments
Experimental: Salsalate
3000 mg/day salsalate (1500 mg twice daily) for 5 days
Placebo_comparator: Placebo
1 capsule contain microcrystalline cellulose filler (twice daily) for 5 days
Related Therapeutic Areas
Sponsors
Leads: Penn State University

This content was sourced from clinicaltrials.gov