Last updated on May 2016

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 M12-817

Other Details:

This study is being conducted at approximately 125 research centers in the United States, Puerto Rico and Canada. Approximately 400 subjects will participate in this study.

Your participation in this study will last approximately 20 months and include 16 – 22 study visits to the research center and approximately 9 visits that will be conducted over the phone. At the end of the Treatment Period, you may have the option of participating in a separate extension study for 6 additional months of treatment with study drug.

This study will take place in three Study Periods. They are the Washout Period, Screening Period and Treatment Period. Not all patients will require a Washout Period. Patients not requiring washout will begin the study during the Screening Period.

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Reading Hospital Clinical Trials Office

301 South 7th Avenue West Reading, PA USA
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