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


Brief description of study

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

Detailed Study Description

The purpose of this study is to determine the safety and effectiveness of elagolix compared to placebo in reducing heavy menstrual bleeding associated with uterine fibroids. Subjects will be randomly assigned to take elagolix or placebo. Some subjects will also be randomly assigned to receive elagolix in combination with add-back therapy (E2/NETA). The aim of add-back therapy is to partially replace the hormones produced by the ovaries that are suppressed by elagolix in order to reduce symptoms associated with low estradiol levels such as hot flashes, and to prevent potential bone loss. This study will also assess whether taking add-back therapy changes the way elagolix works in reducing menstrual bleeding and fibroid size.

Clinical Study Identifier: TX7897

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Reading Hospital Clinical Trials Office

Reading Hospital Clinical Trials Office
West Reading, PA USA
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