Cardiovascular Disease Risk in Women With Endometriosis

Early Phase 1

Recruiting

• Conditions: Endometriosis
• Interventions: Drug: Elagolix

• Registration Number: NCT03746535
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-11-16
• Study First Posted: 2018-11-19
• Study Start: 2022-07-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients without endometriosis	Elagolix	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
patients with endometriosis	Elagolix	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.

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States