Actively Recruiting
Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Women With Endometriosis
Led by Yale University · Updated on 2025-05-23
40
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the increased risk of cardiovascular disease in women with endometriosis. The research aims to understand how estrogen suppression treatments may worsen endothelial dysfunction and chronic inflammation linked to this risk, focusing on the role of the LOX-1 receptor. This trial is an early phase 1 interventional study involving women aged 18 to 45 years. Participants include women with diagnosed endometriosis and healthy control women with regular menstrual cycles. The study evaluates the effects of a drug called Elagolix, taken orally at 400 mg per day for four days. Control participants will not have symptoms or history of endometriosis. The groups are compared without random assignment or masking. During the study, participants will undergo tests including flow mediated vasodilation and microvascular skin blood flow analysis, as well as microdialysis perfusions to assess vascular function. Researchers will monitor cardiovascular and endothelial function to understand disease mechanisms and the impact of estrogen suppression. The study includes careful selection and exclusion criteria and will continue until the end of 2026.
CONDITIONS
Brief Title
Cardiovascular Disease Risk in Women With Endometriosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 45 years
- Women with a confirmed diagnosis of endometriosis
- Healthy women with regular menstrual cycles every 26 to 34 days (controls)
You will not qualify if you...
- Current smokers
- People with diabetes
- People with sleep apnea
- People with blood pressure higher than 140/90
- Women with endometriosis experiencing severe acute pain requiring immediate treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 days
Participants receive Elagolix, taking 400 mg/day orally as 2 tablets daily for 4 days.
1 treatment period with medication
Trial Site Locations
Total: 1 location
1
Yale School of Medicine
New Haven, Connecticut, United States, 06519
Actively Recruiting
Research Team
N
Nina Stachenfeld, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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