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

Primary Purpose

Uterine Fibroids

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Elagolix
Placebo
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids focused on measuring Elagolix, ABT-620, Uterine Fibroids, Heavy Menstrual Bleeding (HMB)

Eligibility Criteria

18 Years - 51 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • ACCEL Research Sites /ID# 209714
  • University of Alabama at Birmingham - Women's and Infant's Center /ID# 209581
  • Unity Health- Searcy Medical Center /ID# 210905
  • Grossmont Ctr Clin Research /ID# 217690
  • Women's Health Care Research Corp /ID# 211472
  • Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 213764
  • Caceres Specialized Gynecology /ID# 214956
  • LCC Medical Research Institute /ID# 213765
  • Genoma Research Group, Inc /ID# 213771
  • A Premier Medical Research of FL /ID# 214947
  • GCP Clinical Research, LLC /ID# 218742
  • Comprehensive Clinical Trials LLC /ID# 217177
  • Georgia Research for Women /ID# 211321
  • Atlanta Women's Research Institute /ID# 217745
  • Medisense Inc /ID# 217750
  • Women's Health of Augusta /ID# 214995
  • Midtown OBGYN North /ID# 209391
  • Journey Medical Research Institute - Snellville /ID# 217309
  • Affinity Clinical Research /ID# 215252
  • Clinical Trials Management, LLC - Covington /ID# 215020
  • Southern Clinical Research A /ID# 213732
  • Johns Hopkins University /ID# 211135
  • NECCR Fall River LLC /ID# 215009
  • Excel Clinical Research /ID# 215936
  • Manhattan Medical Research /ID# 213753
  • Upstate Clinical Research Associates /ID# 215156
  • M3 Wake Research Inc. /ID# 215166
  • Carolina Medical Trials - Winston-Salem /ID# 215027
  • Legacy Medical Group-Gynecologic Oncology /ID# 211016
  • Clinical Research of Philadelphia, LLC /ID# 213741
  • Reading Hospital Clinical Trials Office /ID# 213763
  • Clinical Trials of SC /ID# 210204
  • Chattanooga Medical Research /ID# 215294
  • WR-Medical Research Center of Memphis LLC /ID# 213756
  • Access Clinical Trials, Inc. /ID# 215357
  • Signature Gyn Services /ID# 213883
  • FMC Science, LLC - OB/GYN - Georgetown /ID# 211164
  • University of Texas (UT) Health Women's Research Center at Memorial City /ID# 215193
  • Advances in Health, Inc. /ID# 215847
  • Clinical Trials of Texas, Inc /ID# 213768
  • Discovery Clinical Trials-San Antonio /ID# 214996
  • Storks Research, LLC /ID# 211146
  • Houston Ctr for Clin Research /ID# 215138
  • Seattle Clinical Research Center /ID# 210853
  • North Spokane Women's Health /ID# 209889
  • Emanuelli Research & Development Center LLC /ID# 212715
  • Puerto Rico Medical Research /ID# 212841
  • Mindful Medical Research /ID# 212496

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Elagolix 150 mg

Placebo

Arm Description

Elagolix 150 mg once daily (QD)

Placebo QD

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 20, 2019
Last Updated
March 4, 2022
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03886220
Brief Title
A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 12, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
April 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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. The primary hypothesis is that elagolix, compared to placebo, reduces HMB associated with uterine fibroids in premenopausal women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids
Keywords
Elagolix, ABT-620, Uterine Fibroids, Heavy Menstrual Bleeding (HMB)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elagolix 150 mg
Arm Type
Experimental
Arm Description
Elagolix 150 mg once daily (QD)
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Placebo QD
Intervention Type
Drug
Intervention Name(s)
Elagolix
Other Intervention Name(s)
ABT-620, elagolix sodium, Orilissa
Intervention Description
Oral; Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral; Tablet
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
From Month 0 (Baseline) to Final Month (up to Month 6)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
ACCEL Research Sites /ID# 209714
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35218
Country
United States
Facility Name
University of Alabama at Birmingham - Women's and Infant's Center /ID# 209581
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-7333
Country
United States
Facility Name
Unity Health- Searcy Medical Center /ID# 210905
City
Searcy
State/Province
Arkansas
ZIP/Postal Code
72143-4802
Country
United States
Facility Name
Grossmont Ctr Clin Research /ID# 217690
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Women's Health Care Research Corp /ID# 211472
City
San Diego
State/Province
California
ZIP/Postal Code
92111-3738
Country
United States
Facility Name
Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 213764
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Caceres Specialized Gynecology /ID# 214956
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
LCC Medical Research Institute /ID# 213765
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Genoma Research Group, Inc /ID# 213771
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
A Premier Medical Research of FL /ID# 214947
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763-2833
Country
United States
Facility Name
GCP Clinical Research, LLC /ID# 218742
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609-3588
Country
United States
Facility Name
Comprehensive Clinical Trials LLC /ID# 217177
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Georgia Research for Women /ID# 211321
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312-1200
Country
United States
Facility Name
Atlanta Women's Research Institute /ID# 217745
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Medisense Inc /ID# 217750
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30363
Country
United States
Facility Name
Women's Health of Augusta /ID# 214995
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901-2775
Country
United States
Facility Name
Midtown OBGYN North /ID# 209391
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909-5715
Country
United States
Facility Name
Journey Medical Research Institute - Snellville /ID# 217309
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078-6191
Country
United States
Facility Name
Affinity Clinical Research /ID# 215252
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523-1245
Country
United States
Facility Name
Clinical Trials Management, LLC - Covington /ID# 215020
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Southern Clinical Research A /ID# 213732
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Johns Hopkins University /ID# 211135
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
NECCR Fall River LLC /ID# 215009
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720-2972
Country
United States
Facility Name
Excel Clinical Research /ID# 215936
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Manhattan Medical Research /ID# 213753
City
New York
State/Province
New York
ZIP/Postal Code
10016-6023
Country
United States
Facility Name
Upstate Clinical Research Associates /ID# 215156
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221-6046
Country
United States
Facility Name
M3 Wake Research Inc. /ID# 215166
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612-8106
Country
United States
Facility Name
Carolina Medical Trials - Winston-Salem /ID# 215027
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103-4109
Country
United States
Facility Name
Legacy Medical Group-Gynecologic Oncology /ID# 211016
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210-2900
Country
United States
Facility Name
Clinical Research of Philadelphia, LLC /ID# 213741
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Reading Hospital Clinical Trials Office /ID# 213763
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Clinical Trials of SC /ID# 210204
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Chattanooga Medical Research /ID# 215294
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
WR-Medical Research Center of Memphis LLC /ID# 213756
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120-8328
Country
United States
Facility Name
Access Clinical Trials, Inc. /ID# 215357
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Signature Gyn Services /ID# 213883
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
FMC Science, LLC - OB/GYN - Georgetown /ID# 211164
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78626-8185
Country
United States
Facility Name
University of Texas (UT) Health Women's Research Center at Memorial City /ID# 215193
City
Houston
State/Province
Texas
ZIP/Postal Code
77024-2515
Country
United States
Facility Name
Advances in Health, Inc. /ID# 215847
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Trials of Texas, Inc /ID# 213768
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Discovery Clinical Trials-San Antonio /ID# 214996
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Storks Research, LLC /ID# 211146
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479-1285
Country
United States
Facility Name
Houston Ctr for Clin Research /ID# 215138
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Seattle Clinical Research Center /ID# 210853
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
North Spokane Women's Health /ID# 209889
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
Facility Name
Emanuelli Research & Development Center LLC /ID# 212715
City
Arecibo
ZIP/Postal Code
00612
Country
Puerto Rico
Facility Name
Puerto Rico Medical Research /ID# 212841
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Mindful Medical Research /ID# 212496
City
San Juan
ZIP/Postal Code
00918-3756
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.rxabbvie.com
Description
Related Info

Learn more about this trial

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

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