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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AbbVie
Study ID
NCT03886220
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 51 Years
Healthy Volunteers
Not accepted

Interventions

  • Elagolix — DRUG
    Oral; Tablet
  • Placebo — DRUG
    Oral; Tablet

Study Details

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.

Key Dates

Start date
Apr 12, 2019
Status verified
Mar 2022
Primary completion
Mar 31, 2021
Completion
Apr 28, 2021

Study Design

Enrollment
82 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Elagolix 150 mg
    Elagolix 150 mg once daily (QD)
  • Experimental: Placebo
    Placebo QD

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) ]

Locations (45)

FacilityCityStateZIPSite coordinators
ACCEL Research Sites /ID# 209714BirminghamAlabama35218-
University of Alabama at Birmingham - Women's and Infant's Center /ID# 209581BirminghamAlabama35294-7333-
Unity Health- Searcy Medical Center /ID# 210905SearcyArkansas72143-4802-
Grossmont Ctr Clin Research /ID# 217690La MesaCalifornia91942-
Women's Health Care Research Corp /ID# 211472San DiegoCalifornia92111-3738-
Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 213764Fort MyersFlorida33912-
Caceres Specialized Gynecology /ID# 214956KissimmeeFlorida34741-
Genoma Research Group, Inc /ID# 213771MiamiFlorida33165-
LCC Medical Research Institute /ID# 213765MiamiFlorida33126-
A Premier Medical Research of FL /ID# 214947Orange CityFlorida32763-2833-
GCP Clinical Research, LLC /ID# 218742TampaFlorida33609-3588-
Comprehensive Clinical Trials LLC /ID# 217177West Palm BeachFlorida33409-
Atlanta Women's Research Institute /ID# 217745AtlantaGeorgia30342-
Georgia Research for Women /ID# 211321AtlantaGeorgia30312-1200-
Medisense Inc /ID# 217750AtlantaGeorgia30363-
Women's Health of Augusta /ID# 214995AugustaGeorgia30901-2775-
Midtown OBGYN North /ID# 209391ColumbusGeorgia31909-5715-
Journey Medical Research Institute - Snellville /ID# 217309SnellvilleGeorgia30078-6191-
Affinity Clinical Research /ID# 215252Oak BrookIllinois60523-1245-
Clinical Trials Management, LLC - Covington /ID# 215020CovingtonLouisiana70433-
Southern Clinical Research A /ID# 213732MetairieLouisiana70001-
Johns Hopkins University /ID# 211135BaltimoreMaryland21287-
NECCR Fall River LLC /ID# 215009Fall RiverMassachusetts02720-2972-
Excel Clinical Research /ID# 215936Las VegasNevada89109-
Manhattan Medical Research /ID# 213753New YorkNew York10016-6023-
Upstate Clinical Research Associates /ID# 215156WilliamsvilleNew York14221-6046-
M3 Wake Research Inc. /ID# 215166RaleighNorth Carolina27612-8106-
Carolina Medical Trials - Winston-Salem /ID# 215027Winston-SalemNorth Carolina27103-4109-
Legacy Medical Group-Gynecologic Oncology /ID# 211016PortlandOregon97210-2900-
Clinical Research of Philadelphia, LLC /ID# 213741PhiladelphiaPennsylvania19114-
Reading Hospital Clinical Trials Office /ID# 213763West ReadingPennsylvania19611-
Clinical Trials of SC /ID# 210204CharlestonSouth Carolina29406-
Chattanooga Medical Research /ID# 215294ChattanoogaTennessee37404-
WR-Medical Research Center of Memphis LLC /ID# 213756MemphisTennessee38120-8328-
Access Clinical Trials, Inc. /ID# 215357NashvilleTennessee37203-
Signature Gyn Services /ID# 213883Fort WorthTexas76104-
FMC Science, LLC - OB/GYN - Georgetown /ID# 211164GeorgetownTexas78626-8185-
Advances in Health, Inc. /ID# 215847HoustonTexas77030-
University of Texas (UT) Health Women's Research Center at Memorial City /ID# 215193HoustonTexas77024-2515-
Clinical Trials of Texas, Inc /ID# 213768San AntonioTexas78229-
Discovery Clinical Trials-San Antonio /ID# 214996San AntonioTexas78258-
Houston Ctr for Clin Research /ID# 215138Sugar LandTexas77479-
Storks Research, LLC /ID# 211146Sugar LandTexas77479-1285-
Seattle Clinical Research Center /ID# 210853SeattleWashington98105-
North Spokane Women's Health /ID# 209889SpokaneWashington99207-

Find similar trials in Birmingham, AL

By research site
ACCEL Research Sites· Birmingham, ALUniversity of Alabama at Birmingham - Women's and Infant's Center· Birmingham, ALUnity Health- Searcy Medical Center· Searcy, ARGrossmont Ctr Clin Research· La Mesa, CAWomen's Health Care Research Corp· San Diego, CAAlliance for Multispecialty Research (AMR) - Fort Myers· Fort Myers, FL

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