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Gonadotropin-Releasing Hormone (GnRH) Antagonist

Elagolix + E2/NETA for Heavy Menstrual Bleeding

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
Participant has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound (Transabdominal ultrasound (TAU) and transvaginal ultrasound (TVU))
Participant has an adequate endometrial biopsy performed during Screening, the results of which show no clinical significant endometrial pathology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 60
Awards & highlights

Study Summary

This trial is studying whether a combination of elagolix and estradiol/norethindrone acetate is safe for treating heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

Who is the study for?
This trial is for premenopausal women with heavy menstrual bleeding due to uterine fibroids, confirmed by specific blood loss measurements and pelvic ultrasound. They must not have significant psychiatric disorders, osteoporosis, major bone diseases, or abnormal lab results. Women on long-term systemic corticosteroids or with other serious gynecological conditions are excluded.Check my eligibility
What is being tested?
The study tests the safety of elagolix combined with estradiol/norethindrone acetate (E2/NETA) in managing heavy menstrual bleeding from uterine fibroids. It's a phase 3b trial that starts double-blinded for one year followed by three years open-label where everyone knows what treatment they're getting.See study design
What are the potential side effects?
Potential side effects may include hormonal changes such as mood swings or altered menstrual cycles, digestive issues like nausea or abdominal pain, headaches, and possibly decreased bone density over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with uterine fibroids via ultrasound.
Select...
My recent endometrial biopsy showed no significant issues.
Select...
I have heavy periods due to uterine fibroids, confirmed by tests.
Select...
I am a woman who has not gone through menopause.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Adverse Events (AEs)
Secondary outcome measures
Change in Bone Mineral Density (BMD)

Side effects data

From 2021 Phase 4 trial • 82 Patients • NCT03886220
13%
HEADACHE
11%
HOT FLUSH
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Elagolix 150 mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Elagolix plus estradiol (E2)/norethindrone acetate (NETA)Experimental Treatment2 Interventions
Elagolix plus estradiol (E2)/norethindrone acetate (NETA)
Group II: PlaceboPlacebo Group2 Interventions
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elagolix
2019
Completed Phase 4
~5710
E2/NETA
2016
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
954 Previous Clinical Trials
500,605 Total Patients Enrolled
6 Trials studying Menorrhagia
1,900 Patients Enrolled for Menorrhagia
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
101,057 Total Patients Enrolled
3 Trials studying Menorrhagia
1,224 Patients Enrolled for Menorrhagia
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,439 Total Patients Enrolled
2 Trials studying Menorrhagia
105 Patients Enrolled for Menorrhagia

Media Library

Elagolix (Gonadotropin-Releasing Hormone (GnRH) Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03271489 — Phase 3
Menorrhagia Research Study Groups: Elagolix plus estradiol (E2)/norethindrone acetate (NETA), Placebo
Menorrhagia Clinical Trial 2023: Elagolix Highlights & Side Effects. Trial Name: NCT03271489 — Phase 3
Elagolix (Gonadotropin-Releasing Hormone (GnRH) Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03271489 — Phase 3

Frequently Asked Questions

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

What is the governmental stance on Elagolix?

"Elagolix has been studied in multiple Phase 3 clinical trials, meaning that there is data to suggest that it is effective and safe."

Answered by AI

How does this research on Elagolix compare to other, similar studies?

"Elagolix has a long clinical history, with the first trial taking place in 1996 at the National Institutes of Health Clinical Center. 268 trials have been completed in total, with 63 active trials currently underway. Frisco, Texas is presently hosting many of these active studies."

Answered by AI

Is this trial open to individuals below the age of 40?

"The age requirement to participate in this trial is that you must be over 18 and younger than 50."

Answered by AI

Could you please explain the requirements for participating in this research?

"500 female patients between the ages of 18-50 are being recruited for this leiomyoma trial. Additional requirements for participants include being premenopausal and willing to undergo screening."

Answered by AI

Is this clinical trial prominent in multiple locations throughout the city?

"There are 100 sites across the country enrolling patients in this clinical trial. Some of the locations include Frisco, Miami Lakes, and Saginaw. You can choose the location nearest you to minimize travel requirements if you decide to participate."

Answered by AI

What is the usual purpose of Elagolix medication?

"Elagolix can be used to treat prostate cancer that has progressed and is dependent on androgens, a lack of menstruation for at least 6 months, and low levels of estrogen."

Answered by AI

Are there still opportunities for patients to enroll in this trial?

"This particular clinical trial is no longer enrolling patients. The study began on 2017-09-13 and ended on 2022-01-20. However, there are other ongoing trials that may be of interest. There are currently 435 clinical trials actively recruiting patients with leiomyoma and 63 studies for Elagolix that are still looking for participants."

Answered by AI

What is the total number of people who can join this research project?

"This particular clinical trial is not looking for patients at the moment, as the last edit was done on January 20th, 2022. If you're interested in other trials, 435 leiomyoma trials and 63 Elagolix trials are still recruiting patients."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
2017. "Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03271489.
All > Uterine Fibroids > Fibroids
~11 spots leftby Jul 2024
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