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

March 4, 2022 updated by: AbbVie

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Arecibo, Puerto Rico, 00612
        • Emanuelli Research & Development Center LLC /ID# 212715
      • Ponce, Puerto Rico, 00717
        • Puerto Rico Medical Research /ID# 212841
      • San Juan, Puerto Rico, 00918-3756
        • Mindful Medical Research /ID# 212496
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35218
        • ACCEL Research Sites /ID# 209714
      • Birmingham, Alabama, United States, 35294-7333
        • University of Alabama at Birmingham - Women's and Infant's Center /ID# 209581
    • Arkansas
      • Searcy, Arkansas, United States, 72143-4802
        • Unity Health- Searcy Medical Center /ID# 210905
    • California
      • La Mesa, California, United States, 91942
        • Grossmont Ctr Clin Research /ID# 217690
      • San Diego, California, United States, 92111-3738
        • Women's Health Care Research Corp /ID# 211472
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 213764
      • Kissimmee, Florida, United States, 34741
        • Caceres Specialized Gynecology /ID# 214956
      • Miami, Florida, United States, 33126
        • LCC Medical Research Institute /ID# 213765
      • Miami, Florida, United States, 33165
        • Genoma Research Group, Inc /ID# 213771
      • Orange City, Florida, United States, 32763-2833
        • A Premier Medical Research of FL /ID# 214947
      • Tampa, Florida, United States, 33609-3588
        • GCP Clinical Research, LLC /ID# 218742
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Trials LLC /ID# 217177
    • Georgia
      • Atlanta, Georgia, United States, 30312-1200
        • Georgia Research for Women /ID# 211321
      • Atlanta, Georgia, United States, 30342
        • Atlanta Women's Research Institute /ID# 217745
      • Atlanta, Georgia, United States, 30363
        • Medisense Inc /ID# 217750
      • Augusta, Georgia, United States, 30901-2775
        • Women's Health of Augusta /ID# 214995
      • Columbus, Georgia, United States, 31909-5715
        • Midtown OBGYN North /ID# 209391
      • Snellville, Georgia, United States, 30078-6191
        • Journey Medical Research Institute - Snellville /ID# 217309
    • Illinois
      • Oak Brook, Illinois, United States, 60523-1245
        • Affinity Clinical Research /ID# 215252
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Clinical Trials Management, LLC - Covington /ID# 215020
      • Metairie, Louisiana, United States, 70001
        • Southern Clinical Research A /ID# 213732
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University /ID# 211135
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720-2972
        • NECCR Fall River LLC /ID# 215009
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Excel Clinical Research /ID# 215936
    • New York
      • New York, New York, United States, 10016-6023
        • Manhattan Medical Research /ID# 213753
      • Williamsville, New York, United States, 14221-6046
        • Upstate Clinical Research Associates /ID# 215156
    • North Carolina
      • Raleigh, North Carolina, United States, 27612-8106
        • M3 Wake Research Inc. /ID# 215166
      • Winston-Salem, North Carolina, United States, 27103-4109
        • Carolina Medical Trials - Winston-Salem /ID# 215027
    • Oregon
      • Portland, Oregon, United States, 97210-2900
        • Legacy Medical Group-Gynecologic Oncology /ID# 211016
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Clinical Research of Philadelphia, LLC /ID# 213741
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital Clinical Trials Office /ID# 213763
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Clinical Trials of SC /ID# 210204
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Medical Research /ID# 215294
      • Memphis, Tennessee, United States, 38120-8328
        • WR-Medical Research Center of Memphis LLC /ID# 213756
      • Nashville, Tennessee, United States, 37203
        • Access Clinical Trials, Inc. /ID# 215357
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Signature Gyn Services /ID# 213883
      • Georgetown, Texas, United States, 78626-8185
        • FMC Science, LLC - OB/GYN - Georgetown /ID# 211164
      • Houston, Texas, United States, 77024-2515
        • University of Texas (UT) Health Women's Research Center at Memorial City /ID# 215193
      • Houston, Texas, United States, 77030
        • Advances in Health, Inc. /ID# 215847
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc /ID# 213768
      • San Antonio, Texas, United States, 78258
        • Discovery Clinical Trials-San Antonio /ID# 214996
      • Sugar Land, Texas, United States, 77479-1285
        • Storks Research, LLC /ID# 211146
      • Sugar Land, Texas, United States, 77479
        • Houston Ctr for Clin Research /ID# 215138
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Clinical Research Center /ID# 210853
      • Spokane, Washington, United States, 99207
        • North Spokane Women's Health /ID# 209889

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Elagolix 150 mg
Elagolix 150 mg once daily (QD)
Drug: Elagolix
Oral; Tablet
Other Names:
  • ABT-620
  • Orilissa
  • elagolix sodium
Experimental: Placebo
Placebo QD
Drug: Placebo
Oral; Tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)

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.
From Month 0 (Baseline) to Final Month (up to Month 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M16-824

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing Time Frame

For details on when studies are available for sharing, please refer to the link below.

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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