Cardiovascular Disease Risk in Women With Endometriosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Elagolix.
- Who it may be relevant to
- Registry conditions: Endometriosis. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Women With Endometriosis
Overview
To test the hypothesis that estrogen suppression impairs endothelial dysfunction in endometriosis.
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.
Interventions
- Drug Elagolix
Elagolix, 400 mg/day oral, 2X200 mg tablets/day for 4 days.
Primary outcome measures
- Flow Mediated Vasodilation Microvascular skin blood flow analysis [Time frame: 2 minutes]
- Microdialysis perfusions [Time frame: 15 minutes]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Yale School of Medicine — New Haven
Identifiers
NCT: NCT03746535 · 2000022193 · 1R01HL161000-01