Cardiovascular Disease Risk in Women With Endometriosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2026-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Endometriosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

2 cohort clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

no masking, all subjects have endometriosis

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Elagolix

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Elagolix

Intervention Type DRUG

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

Interventions

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Elagolix

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes