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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

Interventions

Elagolix
Placebo

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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