Recruiting
Early Phase 1

Inflammation

Sponsor:

Penn State University

Code:

NCT05069740

Conditions

Endometriosis

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Salsalate Pill

Placebo

Study Details

Brief 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.

Conditions

Endometriosis

Study ID

NCT05069740

Start date

Jan 1, 2022

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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

Interventions

Salsalate Pill

Salsalate acts as an NFkB inhibitor to reduce systemic inflammation

Placebo

Placebo for the salsalate intervention

Primary outcome measure

  • cutaneous vascular conductance [ Time Frame: 5 days after treatment ]
  • brachial artery diameter and blood flow velocity [ Time Frame: 5 days after treatment ]
  • Sera LOX-1 protein expression [ Time Frame: 5 days after treatment ]
  • Biopsy LOX-1 protein expression [ Time Frame: 5 days after treatment ]

Central Contacts and Locations

Central contacts

Lacy M Alexander, Ph.D.

8148671781lma191@psu.edu

Susan Slimak, RN

814-863-8554sks31@psu.edu

Locations

The Pennsylvania State University

Recruiting

University Park, Pennsylvania, United States, 16801

Contacts

Lacy M Alexander, PhD

814-867-1781lma191@psu.edu

More Information

Sponsor

Penn State University

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

  • skin blood flow
  • inflammation
  • Lectin-like oxidized LDL receptor (LOX-1)
  • intradermal microdialysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Penn State University on 2026-07-27.