A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain

Study Identifier
M14-702
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
Plain Language Summary
Available Language(s): English

Study Details

Medical Condition
  • Endometriosis
  • Study Drug
  • Estradiol/Norethindrone Acetate
  • Placebo for Elagolix
  • Elagolix
  • Placebo for E2/NETA
  • Phase
    Phase 3
    Sex
    Female
    Age
    18 - 49 Years

    Protocol Summary

    The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants including the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy.

    Study Locations

    Location
    Status
    Location
    Central Research Associates /ID# 163087
    Birmingham, Alabama, United States, 35205
    Status
    Not applicable
    Location
    Alabama Clinical Therapeutics, LLC /ID# 145503
    Birmingham, Alabama, United States, 35235-3430
    Status
    Not applicable
    Location
    Alabama Clinical Therapeutics, LLC /ID# 151468
    Birmingham, Alabama, United States, 35235-3430
    Status
    Not applicable
    Location
    Southern Women's Specialists PC /ID# 148750
    Fairhope, Alabama, United States, 36532-3029
    Status
    Not applicable
    Location
    Women's Health Alliance of Mobile /ID# 150083
    Mobile, Alabama, United States, 36604-1410
    Status
    Not applicable
    Location
    University of South Alabama /ID# 148774
    Mobile, Alabama, United States, 36604-3302
    Status
    Not applicable
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