Clinical trial NCT03886220: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Uterine Fibroids
Keywords: Elagolix
ABT-620
Uterine Fibroids
Heavy Menstrual Bleeding (HMB)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-03-22
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
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
timeFrame: From Month 0 (Baseline) to Final Month (up to Month 6)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: ACCEL Research Sites /ID# 209714
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - Women's and Infant's Center /ID# 209581
state: Alabama
city: Searcy
country: United States
facility: Unity Health- Searcy Medical Center /ID# 210905
state: Arkansas
city: La Mesa
country: United States
facility: Grossmont Ctr Clin Research /ID# 217690
state: California
city: San Diego
country: United States
facility: Women's Health Care Research Corp /ID# 211472
state: California
city: Fort Myers
country: United States
facility: Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 213764
state: Florida
city: Kissimmee
country: United States
facility: Caceres Specialized Gynecology /ID# 214956
state: Florida
city: Miami
country: United States
facility: LCC Medical Research Institute /ID# 213765
state: Florida
city: Miami
country: United States
facility: Genoma Research Group, Inc /ID# 213771
state: Florida
city: Orange City
country: United States
facility: A Premier Medical Research of FL /ID# 214947
state: Florida
city: Tampa
country: United States
facility: GCP Clinical Research, LLC /ID# 218742
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials LLC /ID# 217177
state: Florida
city: Atlanta
country: United States
facility: Georgia Research for Women /ID# 211321
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Women's Research Institute /ID# 217745
state: Georgia
city: Atlanta
country: United States
facility: Medisense Inc /ID# 217750
state: Georgia
city: Augusta
country: United States
facility: Women's Health of Augusta /ID# 214995
state: Georgia
city: Columbus
country: United States
facility: Midtown OBGYN North /ID# 209391
state: Georgia
city: Snellville
country: United States
facility: Journey Medical Research Institute - Snellville /ID# 217309
state: Georgia
city: Oak Brook
country: United States
facility: Affinity Clinical Research /ID# 215252
state: Illinois
city: Covington
country: United States
facility: Clinical Trials Management, LLC - Covington /ID# 215020
state: Louisiana
city: Metairie
country: United States
facility: Southern Clinical Research A /ID# 213732
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University /ID# 211135
state: Maryland
city: Fall River
country: United States
facility: NECCR Fall River LLC /ID# 215009
state: Massachusetts
city: Las Vegas
country: United States
facility: Excel Clinical Research /ID# 215936
state: Nevada
city: New York
country: United States
facility: Manhattan Medical Research /ID# 213753
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates /ID# 215156
state: New York
city: Raleigh
country: United States
facility: M3 Wake Research Inc. /ID# 215166
state: North Carolina
city: Winston-Salem
country: United States
facility: Carolina Medical Trials - Winston-Salem /ID# 215027
state: North Carolina
city: Portland
country: United States
facility: Legacy Medical Group-Gynecologic Oncology /ID# 211016
state: Oregon
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC /ID# 213741
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Hospital Clinical Trials Office /ID# 213763
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Trials of SC /ID# 210204
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research /ID# 215294
state: Tennessee
city: Memphis
country: United States
facility: WR-Medical Research Center of Memphis LLC /ID# 213756
state: Tennessee
city: Nashville
country: United States
facility: Access Clinical Trials, Inc. /ID# 215357
state: Tennessee
city: Fort Worth
country: United States
facility: Signature Gyn Services /ID# 213883
state: Texas
city: Georgetown
country: United States
facility: FMC Science, LLC - OB/GYN - Georgetown /ID# 211164
state: Texas
city: Houston
country: United States
facility: University of Texas (UT) Health Women's Research Center at Memorial City /ID# 215193
state: Texas
city: Houston
country: United States
facility: Advances in Health, Inc. /ID# 215847
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc /ID# 213768
state: Texas
city: San Antonio
country: United States
facility: Discovery Clinical Trials-San Antonio /ID# 214996
state: Texas
city: Sugar Land
country: United States
facility: Storks Research, LLC /ID# 211146
state: Texas
city: Sugar Land
country: United States
facility: Houston Ctr for Clin Research /ID# 215138
state: Texas
city: Seattle
country: United States
facility: Seattle Clinical Research Center /ID# 210853
state: Washington
city: Spokane
country: United States
facility: North Spokane Women's Health /ID# 209889
state: Washington
city: Arecibo
country: Puerto Rico
facility: Emanuelli Research & Development Center LLC /ID# 212715
city: Ponce
country: Puerto Rico
facility: Puerto Rico Medical Research /ID# 212841
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research /ID# 212496
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: