Cardiovascular Disease Risk in Women With Endometriosis

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03746535
• Other study ID #: 2000022193
• Secondary ID: 1R01HL161000-01
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 1, 2022
• Est. completion date: August 30, 2025

Study information

• Verified date: June 2024
• Source: Yale University
• Contact: Nina Stachenfeld, PhD
• Phone: 203-562-9901
• Email: nina.stachenfeld[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 30, 2025
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Endometriosis

Intervention

Drug:
• Elagolix
Elagolix, 400 mg/day oral, 2X200 mg tablets/day for 4 days.

Locations

Country	Name	City	State
United States	John B Pierce Laboratory	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

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