A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain
Study Identifier
M16-383
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact
Results Available
Protocol and Statistical Analysis Plan
Available Language(s): English
Study Details
Medical Condition
Study Drug
Phase
Phase 3
Sex
Female
Age
18 - 49 Years
Protocol Summary
This is a Phase 3, dose-escalation study designed to evaluate the safety and efficacy of both elagolix alone and elagolix plus estradiol/norethindrone acetate (E2/NETA) over 24 months in the management of endometriosis with associated moderate to severe pain in premenopausal women.
Study Locations
Location
Status
Location
Pinnacle Research Group /ID# 202016
Anniston, Alabama, United States, 36207
Status
Not applicable
Location
Noble Clinical Research /ID# 170628
Tucson, Arizona, United States, 85704
Status
Not applicable
Location
Lynn Institute of the Ozarks /ID# 165052
Little Rock, Arkansas, United States, 72205
Status
Not applicable
Location
SC Clinical Research /ID# 165049
Garden Grove, California, United States, 92844
Status
Not applicable
Location
Marvel Clinical Research /ID# 169633
Huntington Beach, California, United States, 92647
Status
Not applicable
Location
Health care Affiliates Medical Group /ID# 165048
Santa Ana, California, United States, 92704
Status
Not applicable
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