Cardiovascular Disease Risk in Women With Endometriosis

Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Women With Endometriosis

To test the hypothesis that estrogen suppression impairs endothelial dysfunction in endometriosis.

Study Overview

• Status: Recruiting
• Conditions: Endometriosis
• Intervention / Treatment: Drug: Elagolix

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Nina Stachenfeld, PhD; Phone Number: 219 203-562-9901; Email: nina.stachenfeld@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • John B Pierce Laboratory
      • Contact: Nina Stachenfeld; Phone Number: 203-530-8071; Email: nina.stachenfeld@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flow Mediated Vasodilation Microvascular skin blood flow analysis	Blood flow velocity will be measured using the Sonoscope S2 ultrasound imaging system.	2 minutes
Microdialysis perfusions	Following recovery from the microdialysis probe insertions we will measure resting skin blood flow (SkBF).	15 minutes

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Nina Stachenfeld, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): August 30, 2025

Study Registration Dates

• First Submitted: October 17, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Cardiovascular Diseases; Endometriosis
• Other Study ID Numbers: 2000022193; 1R01HL161000-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes