Endometriosis
Conditions
Brief summary
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
DRUGElagolix
Elagolix, 400 mg/day oral, 2X200 mg tablets/day for 4 days.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Yale University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
no masking, all subjects have endometriosis
Intervention model description
2 cohort clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
Primary ContactNina Stachenfeld, PhD
Outcome results
None listed