Cardiovascular Disease Risk in Women With Endometriosis
Study Details
Study Description
Brief Summary
To test the hypothesis that estrogen suppression impairs endothelial dysfunction in endometriosis.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Early Phase 1 |
Detailed Description
Our scientific premise is that in women with endometriosis, elevated cardiovascular disease risk is the result of endothelial dysfunction and chronic systemic inflammation through lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) receptor activation. This cardiovascular disease risk is exacerbated by standard estrogen suppression treatments.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: patients without endometriosis Control subjects will be healthy women, with regular menses every 26-34 days. Subjects will be excluded if they have any symptoms of endometriosis, including severe dysmenorrhea or progressive cyclic pelvic pain or prior surgery showing evidence of endometriosis |
Drug: Elagolix
Elagolix, 400 mg/day oral, 2X200 mg tablets/day for 4 days.
|
Experimental: patients with endometriosis Endometriosis will be diagnosed by history of the disease seen at the time of prior surgery or will be diagnosed by classic clinical symptoms of the disease (cyclic progressive pelvic pain) using prior surgical report reviewed by Dr. Taylor. |
Drug: Elagolix
Elagolix, 400 mg/day oral, 2X200 mg tablets/day for 4 days.
|
Outcome Measures
Primary Outcome Measures
- Flow Mediated Vasodilation Microvascular skin blood flow analysis [2 minutes]
Blood flow velocity will be measured using the Sonoscope S2 ultrasound imaging system.
- Microdialysis perfusions [15 minutes]
Following recovery from the microdialysis probe insertions we will measure resting skin blood flow (SkBF).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Young women between the ages of 18 and 45 years (Controls);
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Young women between the ages of 18 and 45 years with endometriosis.
Exclusion Criteria:
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Subjects who smoke
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Subjects who have diabetes,
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Subjects with sleep apnea or BP>140/90 will be excluded.
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Women with endometriosis and severe acute pain requiring immediate treatment will be excluded.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | John B Pierce Laboratory | New Haven | Connecticut | United States | 06519 |
Sponsors and Collaborators
- Yale University
Investigators
- Principal Investigator: Nina Stachenfeld, MD, Yale University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2000022193