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
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Results Available

Protocol and Statistical Analysis Plan
Available Language(s): English

Study Details

Medical Condition
  • Endometriosis
  • Study Drug
  • elagolix
  • estradiol/norethindrone acetate (E2/NETA)
  • 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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