Understanding inflammation's role in cardiovascular risk for women with endometriosis
Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Endometriosis
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 |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Penn State University Academic / other |
| Locations | 1 site (University Park, Pennsylvania) |
| Trial ID | NCT05069740 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include healthy women aged 18 to 45 with a diagnosis of endometriosis confirmed by prior laparoscopy.
Not a fit: Patients with pre-existing cardiovascular disease, diabetes, or other significant health issues may not benefit from this study.
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 performed: While there is existing research on endometriosis and cardiovascular risk, this specific approach focusing on LOX-1 and systemic inflammation is relatively novel.
Eligibility criteria
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 this trial is running
University Park, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.