Understanding inflammation's role in cardiovascular risk for women with endometriosis
Official title: Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Endometriosis
Run by Penn State University · NCT05069740 · Data updated 2026-11-12
This study is testing whether a new pill can help women with endometriosis improve their heart health by looking at how inflammation affects their risk for heart disease.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 24 (estimated) |
| Sponsor | Penn State University Academic / other |
| Locations | 1 site (University Park, Pennsylvania) |
| Status | Recruiting |
| Started | January 1, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 27, 2026 |
| Trial ID | NCT05069740 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include healthy women aged 18 to 45 with a diagnosis of endometriosis confirmed by prior laparoscopy.
✕Probably not a fit
Patients with pre-existing cardiovascular disease, diabetes, or other significant health issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to investigate the mechanisms linking endometriosis to increased cardiovascular disease risk in women. It will measure the effectiveness of new treatments for endometriosis on cardiovascular dysfunction outcomes. The research focuses on the role of inflammation and specific biomarkers, such as LDL and oxidized LDL, in this relationship. Participants will receive either a salsalate pill or a placebo to assess the impact on their cardiovascular health.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for women with endometriosis, potentially reducing their cardiovascular disease risk.
How similar studies have gone: While there is existing research on endometriosis and cardiovascular risk, this specific approach focusing on LOX-1 and systemic inflammation is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
The Pennsylvania State University
University Park, Pennsylvania, United States Recruiting
Study contacts
- Study coordinator: Lacy M Alexander, Ph.D.
- Email: lma191@psu.edu
- Phone: 8148671781
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing different techniques to treat endometriosis
This study is testing different methods to treat endometriosis, like laser and heat techniques, to see which one works best for relieving pain in women who are already having surgery for the condition.
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Postoperative Pain Trajectories After Endometriosis Surgery
This study tests how pain changes after endometriosis surgery and whether perioperative pain testing can predict who will have ongoing pain.
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Imaging endometriosis with a special PET tracer in adult women
This study tests whether a PET/CT scan using [18F]AlF-FAPI-74 can help detect endometriosis lesions in women who are planning laparoscopy.
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Fiber supplement for digestive symptoms in endometriosis
A fiber-based supplement is being tested to see if it is safe and helps with gut and vaginal microbiomes and digestive symptoms in women with endometriosis.
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Stellate ganglion block and dexmedetomidine for better sleep after gynecologic laparoscopy
The study tests whether giving a preoperative stellate ganglion block plus intraoperative dexmedetomidine improves sleep after laparoscopic gynecologic surgery in women.
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Atypical Endometriosis: Histology, Immunophenotype and Molecular Features
Researchers will look at how endometriotic tissue that looks atypical under the microscope relates to clinical features and ultrasound findings to better separate benign from potentially atypical lesions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.