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RecruitingAccepts healthy volunteersEarly Phase 1

Endometriosis and Microvascular Dysfunction: Role of Inflammation

Penn State University · NCT05069740

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–45 · Women only
Healthy volunteers
Accepted
Study type
Interventional · Early Phase 1
Target enrollment
24
US sites recruiting
1
Study start
January 1, 2022
Record last updated
July 27, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Salsalate Pill; Placebo

Conditions: Endometriosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Recruiting US locations

  • The Pennsylvania State University

    University Park, PA 16801

    Site contact: Lacy M Alexander, PhD · 814-867-1781 · lma191@psu.edu

Study contacts (from the official record)

  • Lacy M Alexander, Ph.D. · 8148671781 · lma191@psu.edu
  • Susan Slimak, RN · 814-863-8554 · sks31@psu.edu
Endometriosis and Microvascular Dysfunction: Role of Inflammation (NCT05069740) | Bored Studies