Spots Global Cancer Trial Database for 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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Trial Identification
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 ID: NCT03886220
Conditions
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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
ACCEL Research Sites /ID# 209714, Birmingham, Alabama, United States
University of Alabama at Birmingham - Women's and Infant's Center /ID# 209581, Birmingham, Alabama, United States
Unity Health- Searcy Medical Center /ID# 210905, Searcy, Arkansas, United States
Grossmont Ctr Clin Research /ID# 217690, La Mesa, California, United States
Women's Health Care Research Corp /ID# 211472, San Diego, California, United States
Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 213764, Fort Myers, Florida, United States
Caceres Specialized Gynecology /ID# 214956, Kissimmee, Florida, United States
LCC Medical Research Institute /ID# 213765, Miami, Florida, United States
Genoma Research Group, Inc /ID# 213771, Miami, Florida, United States
A Premier Medical Research of FL /ID# 214947, Orange City, Florida, United States
GCP Clinical Research, LLC /ID# 218742, Tampa, Florida, United States
Comprehensive Clinical Trials LLC /ID# 217177, West Palm Beach, Florida, United States
Georgia Research for Women /ID# 211321, Atlanta, Georgia, United States
Atlanta Women's Research Institute /ID# 217745, Atlanta, Georgia, United States
Medisense Inc /ID# 217750, Atlanta, Georgia, United States
Women's Health of Augusta /ID# 214995, Augusta, Georgia, United States
Midtown OBGYN North /ID# 209391, Columbus, Georgia, United States
Journey Medical Research Institute - Snellville /ID# 217309, Snellville, Georgia, United States
Affinity Clinical Research /ID# 215252, Oak Brook, Illinois, United States
Clinical Trials Management, LLC - Covington /ID# 215020, Covington, Louisiana, United States
Southern Clinical Research A /ID# 213732, Metairie, Louisiana, United States
Johns Hopkins University /ID# 211135, Baltimore, Maryland, United States
NECCR Fall River LLC /ID# 215009, Fall River, Massachusetts, United States
Excel Clinical Research /ID# 215936, Las Vegas, Nevada, United States
Manhattan Medical Research /ID# 213753, New York, New York, United States
Upstate Clinical Research Associates /ID# 215156, Williamsville, New York, United States
M3 Wake Research Inc. /ID# 215166, Raleigh, North Carolina, United States
Carolina Medical Trials - Winston-Salem /ID# 215027, Winston-Salem, North Carolina, United States
Legacy Medical Group-Gynecologic Oncology /ID# 211016, Portland, Oregon, United States
Clinical Research of Philadelphia, LLC /ID# 213741, Philadelphia, Pennsylvania, United States
Reading Hospital Clinical Trials Office /ID# 213763, West Reading, Pennsylvania, United States
Clinical Trials of SC /ID# 210204, Charleston, South Carolina, United States
Chattanooga Medical Research /ID# 215294, Chattanooga, Tennessee, United States
WR-Medical Research Center of Memphis LLC /ID# 213756, Memphis, Tennessee, United States
Access Clinical Trials, Inc. /ID# 215357, Nashville, Tennessee, United States
Signature Gyn Services /ID# 213883, Fort Worth, Texas, United States
FMC Science, LLC - OB/GYN - Georgetown /ID# 211164, Georgetown, Texas, United States
University of Texas (UT) Health Women's Research Center at Memorial City /ID# 215193, Houston, Texas, United States
Advances in Health, Inc. /ID# 215847, Houston, Texas, United States
Clinical Trials of Texas, Inc /ID# 213768, San Antonio, Texas, United States
Discovery Clinical Trials-San Antonio /ID# 214996, San Antonio, Texas, United States
Storks Research, LLC /ID# 211146, Sugar Land, Texas, United States
Houston Ctr for Clin Research /ID# 215138, Sugar Land, Texas, United States
Seattle Clinical Research Center /ID# 210853, Seattle, Washington, United States
North Spokane Women's Health /ID# 209889, Spokane, Washington, United States
Emanuelli Research & Development Center LLC /ID# 212715, Arecibo, , Puerto Rico
Puerto Rico Medical Research /ID# 212841, Ponce, , Puerto Rico
Mindful Medical Research /ID# 212496, San Juan, , Puerto Rico
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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