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Cardiovascular Disease Risk in Women With Endometriosis

Primary Purpose

Endometriosis

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Elagolix

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

John B Pierce LaboratoryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

patients without endometriosis

patients with endometriosis

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Flow Mediated Vasodilation Microvascular skin blood flow analysis

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

Microdialysis perfusions

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03746535

First Posted

October 17, 2018

Last Updated

August 16, 2023

Sponsor

Yale University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT03746535

Brief Title

Cardiovascular Disease Risk in Women With Endometriosis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2022 (Actual)

Primary Completion Date

August 30, 2025 (Anticipated)

Study Completion Date

August 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometriosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

2 cohort clinical trial

Masking

None (Open Label)

Masking Description

no masking, all subjects have endometriosis

Allocation

Non-Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

patients without endometriosis

Arm Type

Active Comparator

Arm Description

Arm Title

patients with endometriosis

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Elagolix

Intervention Description

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

Primary Outcome Measure Information:

Title

Flow Mediated Vasodilation Microvascular skin blood flow analysis

Description

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

Time Frame

2 minutes

Title

Microdialysis perfusions

Description

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

Time Frame

15 minutes

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

women

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nina Stachenfeld, PhD

Phone

203-562-9901

Ext

219

nina.stachenfeld@yale.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nina Stachenfeld, MD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

John B Pierce Laboratory

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nina Stachenfeld

Phone

203-530-8071

nina.stachenfeld@yale.edu

12. IPD Sharing Statement

Learn more about this trial

Cardiovascular Disease Risk in Women With Endometriosis

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