Cardiovascular Disease Risk in Women With Endometriosis

Yale University

Status and phase: Enrolling; Early Phase 1

Conditions: Endometriosis

Treatments: Drug: Elagolix

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03746535

1R01HL161000-01 (U.S. NIH Grant/Contract)

2000022193

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

patients without endometriosis

Active Comparator group

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

Treatment:

Drug: Elagolix

patients with endometriosis

Experimental group

Description:

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.

Treatment:

Drug: Elagolix