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 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: Completed
• Conditions: Uterine Fibroids
• Intervention / Treatment: Drug: Placebo; Drug: Elagolix

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 4

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	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

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• Related info

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2019
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): April 28, 2021

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 4, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Elagolix; ABT-620; Uterine Fibroids; Heavy Menstrual Bleeding (HMB)
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Diseases; Connective Tissue Diseases; Neoplasms, Connective Tissue; Menstruation Disturbances; Neoplasms, Muscle Tissue; Uterine Hemorrhage; Hemorrhage; Leiomyoma; Myofibroma; Menorrhagia
• Other Study ID 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