LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Completed · Phase 3

Conditions studied: Heavy Menstrual Bleeding, Uterine Fibroid

In brief

The purpose of this study was to determine the long-term efficacy and safety of relugolix 40 milligrams (mg) once daily co-administered with estradiol (E2) and norethindrone acetate (NETA) for 28 weeks on heavy menstrual bleeding associated with uterine fibroids in participants who previously completed a 24-week treatment period in one of the pivotal studies (MVT-601-3001 or MVT-601-3002).

Key facts

Study ID

NCT03412890

Run by

Myovant Sciences GmbH

People needed

477

Starts

2017-10-19

Expected to finish

2021-01-13

Last updated by the study team

2024-05-09

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

Where it is running

• Birmingham — Birmingham, Alabama, United States
• Mobile — Mobile, Alabama, United States
• Mesa — Mesa, Arizona, United States
• Tucson — Tucson, Arizona, United States
• Little Rock — Little Rock, Arkansas, United States
• Canoga Park — Canoga Park, California, United States
• Huntington Beach — Huntington Beach, California, United States
• La Mesa — La Mesa, California, United States
• Long Beach — Long Beach, California, United States
• Los Angeles — Los Angeles, California, United States
• Los Angeles — Los Angeles, California, United States
• Norwalk — Norwalk, California, United States
• Panorama — Panorama City, California, United States
• San Diego — San Diego, California, United States
• San Diego — San Diego, California, United States
• Denver — Denver, Colorado, United States
• Lakewood — Lakewood, Colorado, United States
• Washington — Washington D.C., District of Columbia, United States
• Aventura — Aventura, Florida, United States
• Clearwater — Clearwater, Florida, United States
• DeLand — DeLand, Florida, United States
• Ft. Lauderdale — Fort Lauderdale, Florida, United States
• Fort Myers — Fort Myers, Florida, United States
• Hialeah — Hialeah, Florida, United States
• Andalusia — Andalusia, Alabama, United States

Full record on ClinicalTrials.gov

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