Cardiovascular Disease Risk in Women With Endometriosis

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03746535
Collaborator
(none)
72
1
2
38
1.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
2 cohort clinical trial2 cohort clinical trial
Masking:
None (Open Label)
Masking Description:
no masking, all subjects have endometriosis
Primary Purpose:
Treatment
Official Title:
Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Women With Endometriosis
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Aug 30, 2025
Anticipated Study Completion Date :
Aug 30, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Flow Mediated Vasodilation Microvascular skin blood flow analysis [2 minutes]

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

  2. Microdialysis perfusions [15 minutes]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 John B Pierce Laboratory New Haven Connecticut United States 06519

Sponsors and Collaborators

  • Yale University

Investigators

  • Principal Investigator: Nina Stachenfeld, MD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT03746535
Other Study ID Numbers:
  • 2000022193
First Posted:
Nov 19, 2018
Last Update Posted:
Jul 12, 2022
Last Verified:
Jul 1, 2022
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2022