Cardiovascular Disease Risk in Women With Endometriosis
Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Women With Endometriosis
2 other identifiers
interventional
40
1 country
1
Brief Summary
To test the hypothesis that estrogen suppression impairs endothelial dysfunction in endometriosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jul 2022
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2018
CompletedFirst Posted
Study publicly available on registry
November 19, 2018
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedMay 23, 2025
May 1, 2025
3.4 years
October 17, 2018
May 22, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
patients without endometriosis
ACTIVE COMPARATORControl 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
EXPERIMENTALEndometriosis 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.
Interventions
Elagolix, 400 mg/day oral, 2X200 mg tablets/day for 4 days.
Eligibility Criteria
You may qualify if:
- Young women between the ages of 18 and 45 years (Controls);
- Young women between the ages of 18 and 45 years with endometriosis.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
Yale School of Medicine
New Haven, Connecticut, 06519, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nina Stachenfeld, MD
Yale University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- no masking, all subjects have endometriosis
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2018
First Posted
November 19, 2018
Study Start
July 1, 2022
Primary Completion
December 1, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
May 23, 2025
Record last verified: 2025-05