Endometriosis and Microvascular Dysfunction: Role of Inflammation
Recruiting
Early Phase 1Interventional Study
Endometriosis
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 45
Sex
Female
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
24 (estimated)
Sponsor
Penn State University · Other
Who this trial is looking for
This trial is looking for women between 18 and 45 years old with or without endometriosis. Participants will help researchers understand how endometriosis may be linked to heart health.
Are You a Good Fit for This Trial?
Rules you outMetabolic diseaseCardiovascular diseaseSkin allergiesGastrointestinal bleeding
You may be able to join if
I am a healthy woman between 18 and 45 years old with regular periods.
I have been diagnosed with endometriosis by laparoscopy in the past 5 years.
I can take Tylenol if I have acute pain.
I am using contraceptives.
You may not be able to join if
I use nicotine products like cigarettes or chewing tobacco.
I have diabetes.
My blood pressure is over 140/90.
I take medications that affect blood vessels.
I am pregnant.
I am breastfeeding.
I use illegal or recreational drugs.
I have liver problems.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 c…
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.
Trial Locations
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Eligibility 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 report…
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
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