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
  • Uterine Fibroids
  • Study Drug
  • Elagolix
  • Placebo
  • 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