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Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist

Elagolix for Endometriosis Pain

Phase 3

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6, month 12

Awards & highlights

Study Summary

This trial is testing a new drug to see if it's effective and safe for treating endometriosis-associated pain in premenopausal women.

Who is the study for?

This trial is for premenopausal women aged 18-49 with a surgical diagnosis of endometriosis within the last 10 years. They must experience moderate to severe pelvic pain or dysmenorrhea and agree to use only certain analgesics. Excluded are those with recent major depression, PTSD, other psychiatric disorders, history of osteoporosis, unstable medical conditions, or chronic pelvic pain not due to endometriosis.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of Elagolix alone and in combination with hormonal therapy (Estradiol/Norethindrone Acetate) against placebos in managing moderate to severe endometriosis-associated pain in adult women before menopause.See study design

What are the potential side effects?

Elagolix may cause side effects like hot flashes, headache, nausea, insomnia, mood changes and decreased bone density. Hormonal add-back therapy can help reduce some side effects but may also include its own risks such as breast tenderness or bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6, month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6, month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6, month 12 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment

Co-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment

Secondary outcome measures

Change From Baseline in DYS at Month 12 Based on Daily Assessment

Change From Baseline in DYS at Month 3 Based on Daily Assessment

Change From Baseline in DYS at Month 6 Based on Daily Assessment

+11 more

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

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Elagolix / Elagolix + E2/NETAExperimental Treatment2 Interventions

Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.

Group II: Elagolix + E2/NETAExperimental Treatment2 Interventions

Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.

Group III: PlaceboPlacebo Group2 Interventions

Placebo for elagolix administered twice daily (BID) plus placebo for estradiol/norethindrone acetate (E2/NETA) administered once daily (QD) for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Estradiol/Norethindrone Acetate

2017

Completed Phase 3

~1910

Elagolix

2019

Completed Phase 4

~5710

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

958 Previous Clinical Trials

501,703 Total Patients Enrolled

14 Trials studying Endometriosis

4,468 Patients Enrolled for Endometriosis

AbbVie Inc.Study DirectorAbbVie

264 Previous Clinical Trials

100,876 Total Patients Enrolled

12 Trials studying Endometriosis

3,638 Patients Enrolled for Endometriosis

Media Library

Elagolix (Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03213457 — Phase 3

Endometriosis Research Study Groups: Placebo, Elagolix / Elagolix + E2/NETA, Elagolix + E2/NETA

Endometriosis Clinical Trial 2023: Elagolix Highlights & Side Effects. Trial Name: NCT03213457 — Phase 3

Elagolix (Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03213457 — Phase 3

Frequently Asked Questions

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

Which patients would best fit the requirements for this medical study?

"This study is investigating endometrioma and thus requires participants who have been diagnosed with endometrioma and are between 18-49 years old. There is space for 681 individuals in the study."

Answered by AI

Yes, Elagolix has been studied in other clinical trials.

"Elagolix was first studied in 1996 at the National Institutes of Health Clinical Center. Currently, there have been 267 completed studies with 64 active clinical trials. Many of these studies are being conducted out of Layton, Utah."

Answered by AI

What is the status of Elagolix in terms of government approval?

"Elagolix has undergone Phase 3 trials, so there is some efficacy data as well as multiple rounds of safety data, making it a safe medication."

Answered by AI

Are there any patients who can still enroll in this clinical trial?

"Although this study is not presently recruiting patients, it was last updated February 14th, 2022. According to the data hosted on clinicaltrials.gov, this trial was first posted on July 7th, 2017. Although this trial might not be ideal for you at this time, there are plenty of other options with 156 other trials currently looking for participants."

Answered by AI

What are the common uses for Elagolix?

"Elagolix is normally prescribed to men suffering from advanced prostate cancer that still produces testosterone. Additionally, this medication can alleviate menopausal symptoms such as hot flashes and night sweats, as well as help women who haven't menstruated in the last 6 months."

Answered by AI

Is this study active in many hospitals across North America?

"Currently, there are 100 spots open for this study at locations such as Tanner Clinic /ID# 148786 in Layton, Genoma Research Group, Inc /ID# 152558 in Miami, and Axcess Medical Center /ID# 148169 in Loxahatchee Groves."

Answered by AI

Does this experiment only consider patients below a certain age?

"This trial is only seeking participants who are between 18-49 years old. If you are outside of that age bracket, there are 14 other trials for people under 18 and 34 trials for those 65 and older."

Answered by AI