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

  • STATUS
    Recruiting
  • sponsor
    AbbVie
Updated on 23 November 2020

Summary

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

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.

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.

Details
Clinical Study IdentifierTX143529
SponsorAbbVie
Last Modified on23 November 2020

Eligibility

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Inclusion Criteria

Please contact us. Must be 21 years old or older
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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