Investigating cardiovascular disease risk in women with endometriosis
Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Women With Endometriosis
This study is testing if a medication for endometriosis can help young women understand their risk of heart problems by looking at how it affects their heart health.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT03746535 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the relationship between endometriosis and cardiovascular disease risk in young women. It tests the hypothesis that estrogen suppression may worsen endothelial dysfunction and chronic inflammation, leading to increased cardiovascular risk. The intervention involves administering Elagolix, a medication used for managing endometriosis, to assess its effects on cardiovascular health. The study will include women aged 18 to 45, both with and without endometriosis, to compare outcomes.
Who should consider this trial
Good fit: Ideal candidates are young women aged 18 to 45, both with endometriosis and healthy controls.
Not a fit: Patients who smoke, have diabetes, sleep apnea, or severe acute pain from endometriosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular health management for women with endometriosis.
How similar studies have performed: While the specific approach of this study is novel, previous research has indicated a link between endometriosis and cardiovascular risk, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Young women between the ages of 18 and 45 years (Controls); * Young women between the ages of 18 and 45 years with endometriosis. Exclusion Criteria: * Subjects who smoke * Subjects who have diabetes, * Subjects with sleep apnea or BP\>140/90 will be excluded. * Women with endometriosis and severe acute pain requiring immediate treatment will be excluded.
Where this trial is running
New Haven, Connecticut
- Yale School of Medicine — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Nina Stachenfeld, MD — Yale University
- Study coordinator: Nina Stachenfeld, PhD
- Email: nina.stachenfeld@yale.edu
- Phone: 203-562-9901
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.