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Uterine FibroidsPhase 4NCT03886220

A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

A Phase 4 study testing Elagolix in people with Uterine Fibroids, run by AbbVie at 48 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women. Read more about this study

Who is it for?
Ages 18 to 51 years, women only
Conditions the study is for
Uterine Fibroids
What is being tested?
Elagolix
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
82 participants
Where
48 sitesin 2 countries
Study dates
12 Apr 2019to 28 Apr 2021
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 51 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Participant at the time of screening has a diagnosis of uterine fibroids documented by a pelvic ultrasound [transabdominal ultrasound (TAU) and transvaginal ultrasound (TVU)].
  • Participant has HMB associated with uterine fibroids as evidenced by menstrual blood loss (MBL) > 80 mL during 1 menses in screening as measured by the alkaline hematin method.
  • Participant has negative urine and/or serum pregnancy test in Washout (if applicable) and/or Screening and just prior to first dose.
  • Participant has an adequate endometrial biopsy performed during Screening, the results of which show no clinical significant endometrial pathology.

Who cannot join

  • Participant has screening pelvic ultrasound or saline infusion sonohysterography (SIS) or magnetic resonance imaging (MRI; if SIS is unevaluable), results that show a clinically significant gynecological disorder.
  • Participant has history of osteoporosis, osteopenia, or other metabolic bone disease.
  • Participant has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.
  • Participant has a history of major depression or post-traumatic stress disorder (PTSD) episode within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).
  • Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over the counter and prescription topical, inhaled, intranasal or intra-articular injectable (for occasional use) corticosteroids are allowed.

Trial locations and contacts

48 sites in 2 countries.

48 sites in 2 countries

United States45 sites

  • Georgia Research for Women /ID# 211321

    Atlanta, Georgia, 30312-1200

  • Atlanta Women's Research Institute /ID# 217745

    Atlanta, Georgia, 30342

  • Medisense Inc /ID# 217750

    Atlanta, Georgia, 30363

  • Women's Health of Augusta /ID# 214995

    Augusta, Georgia, 30901-2775

  • Johns Hopkins University /ID# 211135

    Baltimore, Maryland, 21287

  • ACCEL Research Sites /ID# 209714

    Birmingham, Alabama, 35218

  • University of Alabama at Birmingham - Women's and Infant's Center /ID# 209581

    Birmingham, Alabama, 35294-7333

  • Clinical Trials of SC /ID# 210204

    Charleston, South Carolina, 29406

  • Chattanooga Medical Research /ID# 215294

    Chattanooga, Tennessee, 37404

  • Midtown OBGYN North /ID# 209391

    Columbus, Georgia, 31909-5715

  • Clinical Trials Management, LLC - Covington /ID# 215020

    Covington, Louisiana, 70433

  • NECCR Fall River LLC /ID# 215009

    Fall River, Massachusetts, 02720-2972

  • Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 213764

    Fort Myers, Florida, 33912

  • Signature Gyn Services /ID# 213883

    Fort Worth, Texas, 76104

  • FMC Science, LLC - OB/GYN - Georgetown /ID# 211164

    Georgetown, Texas, 78626-8185

  • University of Texas (UT) Health Women's Research Center at Memorial City /ID# 215193

    Houston, Texas, 77024-2515

  • Advances in Health, Inc. /ID# 215847

    Houston, Texas, 77030

  • Caceres Specialized Gynecology /ID# 214956

    Kissimmee, Florida, 34741

  • Grossmont Ctr Clin Research /ID# 217690

    La Mesa, California, 91942

  • Excel Clinical Research /ID# 215936

    Las Vegas, Nevada, 89109

  • WR-Medical Research Center of Memphis LLC /ID# 213756

    Memphis, Tennessee, 38120-8328

  • Southern Clinical Research A /ID# 213732

    Metairie, Louisiana, 70001

  • LCC Medical Research Institute /ID# 213765

    Miami, Florida, 33126

  • Genoma Research Group, Inc /ID# 213771

    Miami, Florida, 33165

  • Access Clinical Trials, Inc. /ID# 215357

    Nashville, Tennessee, 37203

  • Manhattan Medical Research /ID# 213753

    New York, New York, 10016-6023

  • Affinity Clinical Research /ID# 215252

    Oak Brook, Illinois, 60523-1245

  • A Premier Medical Research of FL /ID# 214947

    Orange City, Florida, 32763-2833

  • Clinical Research of Philadelphia, LLC /ID# 213741

    Philadelphia, Pennsylvania, 19114

  • Legacy Medical Group-Gynecologic Oncology /ID# 211016

    Portland, Oregon, 97210-2900

  • M3 Wake Research Inc. /ID# 215166

    Raleigh, North Carolina, 27612-8106

  • Clinical Trials of Texas, Inc /ID# 213768

    San Antonio, Texas, 78229

  • Discovery Clinical Trials-San Antonio /ID# 214996

    San Antonio, Texas, 78258

  • Women's Health Care Research Corp /ID# 211472

    San Diego, California, 92111-3738

  • Unity Health- Searcy Medical Center /ID# 210905

    Searcy, Arkansas, 72143-4802

  • Seattle Clinical Research Center /ID# 210853

    Seattle, Washington, 98105

  • Journey Medical Research Institute - Snellville /ID# 217309

    Snellville, Georgia, 30078-6191

  • North Spokane Women's Health /ID# 209889

    Spokane, Washington, 99207

  • Storks Research, LLC /ID# 211146

    Sugar Land, Texas, 77479-1285

  • Houston Ctr for Clin Research /ID# 215138

    Sugar Land, Texas, 77479

  • GCP Clinical Research, LLC /ID# 218742

    Tampa, Florida, 33609-3588

  • Comprehensive Clinical Trials LLC /ID# 217177

    West Palm Beach, Florida, 33409

  • Reading Hospital Clinical Trials Office /ID# 213763

    West Reading, Pennsylvania, 19611

  • Upstate Clinical Research Associates /ID# 215156

    Williamsville, New York, 14221-6046

  • Carolina Medical Trials - Winston-Salem /ID# 215027

    Winston-Salem, North Carolina, 27103-4109

Other trials in United States

Puerto Rico3 sites

  • Emanuelli Research & Development Center LLC /ID# 212715

    Arecibo, 00612

  • Puerto Rico Medical Research /ID# 212841

    Ponce, 00717

  • Mindful Medical Research /ID# 212496

    San Juan, 00918-3756

Other trials in Puerto Rico

About this study

Official title: A Phase 4 Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women. The primary hypothesis is that elagolix, compared to placebo, reduces HMB associated with uterine fibroids in premenopausal women.

Being tested
Elagolix, Placebo
Keywords
Elagolix, ABT-620, Uterine Fibroids, Heavy Menstrual Bleeding (HMB)
Medical subject headings
Leiomyoma, Menorrhagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElagolixDrug

    Also called ABT-620, elagolix sodium, Orilissa

    Oral; Tablet

  • PlaceboDrug

    Oral; Tablet

Study groups in NCT03886220
Study groupRoleWhat they receive
Elagolix 150 mgExperimentalElagolix 150 mg once daily (QD)
Receives: Drug: Elagolix
PlaceboExperimentalPlacebo QD
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Were Responders With Menstrual Blood Loss (MBL) Volume < 80 mL at Final Month and >= 50% Reduction in MBL Volume From Baseline to the Final Month

    Responders were defined as participants meeting the following 2 conditions:

    • menstrual blood loss (MBL) volume < 80 mL at the Final Month (defined as the last 28 days prior to and including the last dose day), and
    • 50% or greater reduction in MBL volume from Baseline to the Final Month.

    Participants whose primary reason for prematurely discontinuing study drug was "lack of efficacy," or "requires surgery or invasive intervention for treatment of uterine fibroids" were considered as non-responders. MBL was measured by the alkaline hematin method.

    Measured: From Month 0 (Baseline) to Final Month (up to Month 6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2019
  2. Study start12 Apr 2019
  3. Primary completion31 Mar 2021
  4. Study completion28 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03886220
Sponsor's protocol ID
M16-824
Status last verified
Mar 2022
First submitted
20 Mar 2019
Last updated
31 Mar 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

  • Brown E, Kroll R, Li H, Ng J, Pinsky B, Rodriguez JW, Thomas J, Snabes MC. Low-Dose Elagolix for the Treatment of Heavy Menstrual Bleeding in Patients With Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2023 Nov 1;142(5):1068-1076. doi: 10.1097/AOG.0000000000005380. Epub 2023 Sep 28.

    PubMed 37769311

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Elagolix in people with Uterine Fibroids, run by AbbVie at 48 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Were Responders With Menstrual Blood Loss (MBL) Volume < 80 mL at Final Month and >= 50% Reduction in MBL Volume From Baseline to the Final Month (time frame: From Month 0 (Baseline) to Final Month (up to Month 6)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03886220, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.

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