Last updated on September 2017

LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids


Brief description of study

The purpose of this study is to determine the benefit and safety of relugolix 40 mg once daily co-administered with low dose estradiol and norethindrone acetate compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids. Additionally, this study is designed to evaluate the benefit of relugolix 40 mg once daily for 12 weeks followed by 12 weeks of relugolix 40 mg once daily co-administered with low dose estradiol and norethindrone acetate compared with placebo for 24 weeks in the same population.

Detailed Study Description

This study is an international phase 3 randomized, double-blind, placebo-controlled efficacy and safety study to evaluate 24 weeks of oral daily relugolix 40 mg co-administered with low-dose estradiol and norethindrone acetate (Group A) and 12 weeks of daily oral relugolix 40 mg alone followed by 12 weeks of daily oral relugolix 40 mg co-administered with low-dose estradiol and norethindrone acetate (Group B) compared with 24 weeks of placebo (Group C). Approximately 390 women with heavy menstrual bleeding associated with uterine fibroids will be enrolled in the study and will participate for approximately 10 months. Participation will include an ~ 11 week screening period, 24 weeks of treatment and a follow up period of ~ 30 days. A diagnosis of uterine fibroids will be confirmed during the screening period by centrally-reviewed transvaginal and/or transabdominal ultrasound. Following successful completion of the Screening period study participants will be randomized to Treatment Group A, B, or C and will attend visits monthly (ie, every 4 weeks). Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms, and assessments of bone mineral density. All patients completing the Week 24 visit, including women randomized to placebo, will be offered the opportunity to enroll in an open-label extension study in which all eligible patients will receive relugolix co-administered with low-dose estradiol and norethindrone acetate. Patients who do not enroll into the extension study will have a follow-up visit approximately 30 days after the end of treatment (ie, after the patient's last dose of study medication).

Clinical Study Identifier: NCT03049735

.

Contact Investigators or Research Sites near you

Start Over

Please choose location

View all locations

Clinical Trials at Myovant

Andaluisa
Andalusia, AL United States
  Connect »

Clinical Trials at Myovant

Mobile
Mobile, AL United States
  Connect »

Clinical Trials at Myovant

Little Rock
Little Rock, AR United States
  Connect »

Clinical Trials at Myovant

La Mesa
La Mesa, CA United States
  Connect »

Clinical Trials at Myovant

Lomita
Lomita, CA United States
  Connect »

Clinical Trials at Myovant

Norwalk
Norwalk, CA United States
  Connect »

Clinical Trials at Myovant

San Diego
San Diego, CA United States
  Connect »

Clinical Trials at Myovant

Denver
Denver, CO United States
  Connect »

Clinical Trials at Myovant

Aventura
Aventura, FL United States
  Connect »

Clinical Trials at Myovant

Clearwater
Clearwater, FL United States
  Connect »

Clinical Trials at Myovant

Doral
Doral, FL United States
  Connect »

Clinical Trials at Myovant

Fort Myers
Fort Myers, FL United States
  Connect »

Clinical Trials at Myovant

Hialeah
Hialeah, FL United States
  Connect »

Clinical Trials at Myovant

Margate
Margate, FL United States
  Connect »

Clinical Trials at Myovant

Miami
Miami, FL United States
  Connect »

Clinical Trials at Myovant

Palm Harbor
Palm Harbor, FL United States
  Connect »

Clinical Trials at Myovant

West Palm Beach
West Palm Beach, FL United States
  Connect »

Clinical Trials at Myovant

Atlanta
Atlanta, GA United States
  Connect »

Clinical Trials at Myovant

Oakbrook
Oakbrook Terrace, IL United States
  Connect »

Clinical Trials at Myovant

Lafayette
Lafayette, IN United States
  Connect »

Clinical Trials at Myovant

Covington
Covington, LA United States
  Connect »

Clinical Trials at Myovant

Metairie
Metairie, LA United States
  Connect »

Clinical Trials at Myovant

Shreveport
Shreveport, LA United States
  Connect »

Clinical Trials at Myovant

Lincoln
Lincoln, NE United States
  Connect »

Clinical Trials at Myovant

Omaha
Omaha, NE United States
  Connect »

Clinical Trials at Myovant

Las Vegas
Las Vegas, NV United States
  Connect »

Clinical Trials at Myovant

Lawrenceville
Lawrenceville, NJ United States
  Connect »

Clinical Trials at Myovant

Albuquerque
Albuquerque, NM United States
  Connect »

Clinical Trials at Myovant

Williamsville
Williamsville, NY United States
  Connect »

Clinical Trials at Myovant

Durham
Durham, NC United States
  Connect »

Clinical Trials at Myovant

Morehead City
Morehead City, NC United States
  Connect »

Clinical Trials at Myovant

Raleigh
Raleigh, NC United States
  Connect »

Clinical Trials at Myovant

Fargo
Fargo, ND United States
  Connect »

Clinical Trials at Myovant

Minot
Minot, ND United States
  Connect »

Clinical Trials at Myovant

Cincinnati
Cincinnati, OH United States
  Connect »

Clinical Trials at Myovant

Englewood
Englewood, OH United States
  Connect »

Clinical Trials at Myovant

Philadelphia
Philadelphia, PA United States
  Connect »

Clinical Trials at Myovant

Bluffton
Bluffton, SC United States
  Connect »

Clinical Trials at Myovant

Columbia
Columbia, SC United States
  Connect »

Clinical Trials at Myovant

Chattanooga
Chattanooga, TN United States
  Connect »

Clinical Trials at Myovant

Memphis
Memphis, TN United States
  Connect »

Clinical Trials at Myovant

Fort Worth
Fort Worth, TX United States
  Connect »

Clinical Trials at Myovant

Houston
Houston, TX United States
  Connect »

Clinical Trials at Myovant

Irving
Irving, TX United States
  Connect »

Clinical Trials at Myovant

San Antonio
San Antonio, TX United States
  Connect »

Clinical Trials at Myovant

Sugar Land
Sugar Land, TX United States
  Connect »

Clinical Trials at Myovant

Webster
Webster, TX United States
  Connect »

Clinical Trials at Myovant

Salt Lake City
Salt Lake City, UT United States
  Connect »

Clinical Trials at Myovant

Norfolk
Norfolk, VA United States
  Connect »

Clinical Trials at Myovant

Seattle
Seattle, WA United States
  Connect »