Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)

Official Title

A Phase 3 Study to Evaluate the Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Summary:

This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

Trial Description

Primary Outcome:

  • Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Final Month
Secondary Outcome:
  • Change in MBL volume
  • Monthly Change in MBL Volume
  • Percentage of Subjects with Suppression of Bleeding
  • Percentage of Subjects with Increase in Hemoglobin

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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