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Clinical Trial Details

Title
LIBERTY EXTENSION: An International Phase 3 Open-Label, Single-Arm, Long-Term Efficacy and Safety Extension Study to Evaluate Relugolix Co-Administered with Low-Dose Estradiol and Norethindrone Acetate in Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids
Study Purpose
The purpose of this study is to test the long-term effectiveness and safety of the investigational study drug, relugolix (rel-U-GO-lix), given with FDA approved low-dose estradiol (estrogen) and norethindrone acetate (progesterone) to treat your condition, uterine fibroids and heavy menstrual bleeding. The low-dose estrogen and progesterone medication has been approved by the FDA as replacement hormone therapy to prevent bone loss. The use of the FDA approved low-dose estradiol (estrogen) and norethindrone acetate (progesterone) with relugolix to treat participants with heavy menstrual bleeding associated with uterine fibroids is investigational.
Study Plan
Because this is a research study, the study drug will be given to you only during this study and not after the study is over. What will be done only because you are in this research study? Your expected participation in this study will last about 8 months. During this time, you will need to have tests done for study purposes. These tests are explained later in the consent. You will also need to visit the clinic on schedule, and tell the study staff about any changes to your health.
Investigators

Principal Investigator
Andrew M. Kaunitz, M.D., FACOG
Obstetrics and Gynecology

Sub Investigator
Ghania F. Masri, M.D.
Medicine

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