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NCT Number: NCT03746535

Cardiovascular Disease Risk in Women With Endometriosis

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

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Yale School of Medicine

New Haven, Connecticut, 06519, United States

Location status: Recruiting

Location contact

Nina Stachenfeld

CONTACT

[email protected]

203-530-8071

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Elagolix

Drug

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

Primary outcomes

  1. Flow Mediated Vasodilation Microvascular skin blood flow analysis

    Time frame: 2 minutes

    Blood flow velocity will be measured using the Sonoscope S2 ultrasound imaging system.

  2. Microdialysis perfusions

    Time frame: 15 minutes

    Following recovery from the microdialysis probe insertions we will measure resting skin blood flow (SkBF).

Study contacts

Contact information is provided by the study sponsor or research team.

Nina Stachenfeld, PhD

CONTACT

[email protected]

203-562-9901 ext. 219

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Nov 19, 2018
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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