NCT05069740RecruitingEarly phase 1
Endometriosis and Microvascular Dysfunction: Role of Inflammation
Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Endometriosis
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 10 Sept 2021
- Start date
- 1 Jan 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Penn State University
- Diseases
- Endometriosis
- NCT number
- NCT05069740
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 24
- From 1 Jan 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking pharmacotherapy that could alter peripheral vascular control (e.g. insulin sensitizing, cardiovascular medications)
- Taking illicit and/or recreational drugs
Other illness
- Rash, skin disease, disorders of pigmentation, known skin allergies
- Diagnosed or suspected metabolic or cardiovascular disease
- Known allergy to latex or investigative substances (including salsalate or simvastatin)
- History of gastrointestinal bleeding
Lab values
- Diabetes (HbA1C 6.5%)
- Persistent unexplained elevations of serum transaminases
Other
- Use of nicotine-containing products (e.g. smoking, chewing tobacco, etc.)
- BP\>140/90
- Pregnancy
- Breastfeeding
- Abnormal liver function
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Pennsylvania State University Coordinator of this site? Confirm its status | University Park | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.