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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 minutes

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am a woman aged between 18 and 45.

Select...

I am a woman aged 18-45 with endometriosis.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

~5710

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,835 Previous Clinical Trials

47,310,618 Total Patients Enrolled

Yale UniversityLead Sponsor

1,848 Previous Clinical Trials

2,737,794 Total Patients Enrolled

2 Trials studying Endometriosis

514 Patients Enrolled for Endometriosis

Nina Stachenfeld, MDPrincipal InvestigatorYale University

Media Library

Elagolix (Gonadotropin-releasing hormone (GnRH) antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03746535 — Phase < 1

Endometriosis Research Study Groups: patients without endometriosis, patients with endometriosis

Endometriosis Clinical Trial 2023: Elagolix Highlights & Side Effects. Trial Name: NCT03746535 — Phase < 1

Elagolix (Gonadotropin-releasing hormone (GnRH) antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03746535 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research novel in comparison to its predecessors?

"AbbVie funded the first clinical trial of Elagolix in 2017, which included 681 participants. Following its success, it was certified for Phase 3 use and is now being researched across 229 cities in three nations with seven active studies."

Answered by AI

What other research studies have utilized Elagolix as part of their methodology?

"Currently, there are 7 trials researching Elagolix with 4 of them in Phase 3. Most clinical sites for this trial can be found in Miami Lakes, Florida; however, a total of 596 medical centres across the world have been approved to conduct studies on Elagolix."

Answered by AI

Is there any availability for individuals to take part in this research experiment?

"The data hosted on clinicaltrials.gov suggests that recruitment is ongoing for this medical study, which was first introduced to the public on July 1st 2022 and most recently updated November 7th of the same year."

Answered by AI

Is the age restriction for this study limited to those over sixty years of age?

"The minimum age requirement to participate in this trial is 18, with a maximum of 45. For those under the legal threshold and over 65 years old, there are 32 and 383 respective trials that may suit their needs."

Answered by AI

Am I able to participate in this clinical experiment?

"Individuals between the ages of 18 and 45 who present symptoms of endometrioma are eligible for this trial. 24 participants will be recruited in total."

Answered by AI

How many participants is this experiment recruiting?

"Affirmative. The clinical trial website lists this study as presently recruiting, which began on July 1st 2022 and was most recently modified on November 7th of the same year. There is a need for 24 patients to be accrued from one medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cardiovascular Disease Risk in Women With Endometriosis

2022. "Cardiovascular Disease Risk in Women With Endometriosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03746535.

All > Cardiovascular > Endometriosis