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Cardiovascular Disease Risk in Women With Endometriosis

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ClinicalTrials.gov Identifier: NCT03746535
Recruitment Status : Not yet recruiting
First Posted : November 19, 2018
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Description
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Brief Summary:
To test the hypothesis that estrogen suppression impairs endothelial dysfunction in endometriosis.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Elagolix Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 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
Estimated Study Start Date : November 30, 2021
Estimated Primary Completion Date : August 30, 2025
Estimated Study Completion Date : August 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
Drug Information available for: Elagolix

Arms and Interventions
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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
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Primary Outcome Measures :
  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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746535


Contacts
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Contact: Nina Stachenfeld, MD 203-562-9901 ext 219 nina.stachenfeld@yale.edu

Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Nina Stachenfeld, MD Yale University
More Information
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03746535    
Other Study ID Numbers: 2000022193
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Endometriosis
Cardiovascular Diseases