A Phase 4 interventional study of Atorvastatin in Endometriosis, sponsored by Penn State University. Terminated at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by Penn State University · Phase 4, Interventional, and Basic science
Endometriosis is a disorder that occurs in women. With endometriosis, tissue that should be found in the womb is found in sites outside of the womb. This disorder impairs the function of the cells that line the body's blood vessels (endothelium). The endothelium helps to control blood flow in healthy vessels. Women with this disorder have an increased risk for high blood pressure and high cholesterol. They have a higher risk for cardiovascular disease, too. With this study, we will learn how endometriosis impairs the lining of blood vessels and increases the risk for disease.
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. We hypothesis that one factor mediating the elevated risk of cardiovascular disease in endometriosis is microRNA (miRNA) activation of LOX-1 receptor mechanisms.
Specific Aim 1. To test the hypothesis that LOX-1 receptor activation is increased leading to endothelial dysfunction in endometriosis.
Specific Aim 2. To test the hypothesis that decreased microRNAs (i.e. let7-a, let7-b, let7-g, MiR98, Mi590-p) are driving increased LOX-1 receptor expression and function in endometriosis.
901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.
This study's enrollment of 6 is below the median of 64 across 525 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Penn State University is the lead sponsor of 263 studies on the registry; 51 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Oral atorvastatin (Lipitor) therapy (10mg/day) for seven days. Atorvastatin acts as a systemic LOX inhibitor.
Drug: Atorvastatin
Simvastation acts as a systemic LOX inhibitor.
Change in Nitric Oxide Dependent Vasodilation in the Skin
area under the curve of laser Doppler flux/mean arterial pressure \* log acetylcholine (mol/L)
Time frame: before and after intervention (7 days)
All endometriosis patients had a confirmed diagnosis prior to enrollment via laparoscopy.
| Milestone | Atorvastatin |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
area under the curve of laser Doppler flux/mean arterial pressure \* log acetylcholine (mol/L)
| flux/MAP*logAch(mol/L) | Atorvastatin |
|---|---|
| Change in Nitric Oxide Dependent Vasodilation in the Skin | 200 ± 80 |
Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Atorvastatin | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Continuous(years) | Atorvastatin |
|---|---|
| Mean | 33 ± 9 |
| Sex: Female, Male(Participants) | Atorvastatin |
|---|---|
| Female | 6 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Atorvastatin |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 5 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Atorvastatin |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 5 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Atorvastatin |
|---|---|
| United States | 6 |
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This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Penn State University