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Gonadotropin-releasing hormone (GnRH) antagonist

Elagolix for Endometriosis

Phase < 1

Recruiting

Led By Nina Stachenfeld, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Young women between the ages of 18 and 45 years (Controls)

Young women between the ages of 18 and 45 years with endometriosis

Must not have

Subjects who have diabetes

Women with endometriosis and severe acute pain requiring immediate treatment will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at whether reducing estrogen levels impacts endometriosis patients' ability to function normally.

Who is the study for?

This trial is for young women aged 18-45, both healthy and those with endometriosis. It's not open to women who have diabetes, severe acute pain from endometriosis needing immediate treatment, high blood pressure (BP>140/90), sleep apnea, or those who smoke.

What is being tested?

The study is testing Elagolix to see if reducing estrogen levels affects the health of blood vessels in women with endometriosis. The idea is that less estrogen might lead to worse vessel function.

What are the potential side effects?

Elagolix may cause side effects like hot flashes, headache, fatigue, insomnia, mood changes and bone loss due to its action on hormone levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged between 18 and 45.

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I am a woman aged 18-45 with endometriosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes.

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I do not have severe acute pain from endometriosis needing immediate treatment.

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I do not have sleep apnea and my blood pressure is below 140/90.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Flow Mediated Vasodilation Microvascular skin blood flow analysis

Microdialysis perfusions

Side effects data

From 2021 Phase 4 trial • 82 Patients • NCT03886220

13%

HEADACHE

11%

HOT FLUSH

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Elagolix 150 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: patients with endometriosisExperimental Treatment1 Intervention

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 II: patients without endometriosisActive Control1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Elagolix

2019

Completed Phase 4

~6190

0 / 5Eligibility criteria met