A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Study Identifier
M16-824
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact
Study Complete
Results Available
Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Scientific Result Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English
Study Details
Medical Condition
Study Drug
Phase
Phase 4
Sex
Female
Age
18 - 51 Years
Protocol 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.
Study Locations
Location
Status
Location
ACCEL Research Sites /ID# 209714
Birmingham, Alabama, United States, 35218
Status
Not applicable
Location
University of Alabama at Birmingham - Women's and Infant's Center /ID# 209581
Birmingham, Alabama, United States, 35294-7333
Status
Not applicable
Location
Unity Health- Searcy Medical Center /ID# 210905
Searcy, Arkansas, United States, 72143-4802
Status
Not applicable
Location
Grossmont Ctr Clin Research /ID# 217690
La Mesa, California, United States, 91942
Status
Not applicable
Location
Women's Health Care Research Corp /ID# 211472
San Diego, California, United States, 92111-3738
Status
Not applicable
Location
Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 213764
Fort Myers, Florida, United States, 33912
Status
Not applicable
Showing {first} - {last} of {total} Results