Endometriosis and Microvascular Dysfunction: Role of Inflammation

Part of paid clinical trials in University Park, Pennsylvania.

Sponsor
Penn State University
Study ID
NCT05069740
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Salsalate Pill — DRUG
    Salsalate acts as an NFkB inhibitor to reduce systemic inflammation
  • Placebo — DRUG
    Placebo for the salsalate intervention

Study Details

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.

Key Dates

Start date
Jan 1, 2022
Status verified
Nov 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • 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

Primary Outcome Measure

cutaneous vascular conductance [ Time Frame: 5 days after treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Pennsylvania State UniversityUniversity ParkPennsylvania16801
Lacy M Alexander, PhD
[email protected]
814-867-1781

Find similar trials in University Park, PA

By condition
Endometriosis
By specialty
Women's healthFertility
By research site
The Pennsylvania State University· University Park, PA

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