Last updated on March 2018

LIBERTY 2: 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: NCT03103087

Contact Investigators or Research Sites near you

Start Over

Clinical Trials at Myovant

Tuscon
Tucson, AZ United States
  Connect »

Clinical Trials at Myovant

Birmingham
Birmingham, AL United States
  Connect »

Clinical Trials at Myovant

Mesa
Mesa, AZ United States
  Connect »

Clinical Trials at Myovant

Long Beach
Long Beach, CA United States
  Connect »

Clinical Trials at Myovant

Los Angeles
Los Angeles, CA United States
  Connect »

Clinical Trials at Myovant

San Diego
San Diego, CA United States
  Connect »

Clinical Trials at Myovant

Lakewood
Lakewood, CO United States
  Connect »

Clinical Trials at Myovant

Washington
Washington, WA United States
  Connect »

Clinical Trials at Myovant

Aventura
Aventura, FL United States
  Connect »

Clinical Trials at Myovant

DeLand
DeLand, FL United States
  Connect »

Clinical Trials at Myovant

Ft. Lauderdale
Fort Lauderdale, FL United States
  Connect »

Clinical Trials at Myovant

Jupiter
Jupiter, FL United States
  Connect »

Clinical Trials at Myovant

Loxahachee
Loxahatchee Groves, FL United States
  Connect »

Clinical Trials at Myovant

Miami Springs
Miami Springs, FL United States
  Connect »

Clinical Trials at Myovant

New Port Richey
New Port Richey, FL United States
  Connect »

Clinical Trials at Myovant

North Miami
North Miami, FL United States
  Connect »

Clinical Trials at Myovant

Oviedo
Oviedo, FL United States
  Connect »

Clinical Trials at Myovant

Plantation
Plantation, FL United States
  Connect »

Clinical Trials at Myovant

Port St. Lucie
Port Saint Lucie, FL United States
  Connect »

Clinical Trials at Myovant

Saint Cloud
Saint Cloud, FL United States
  Connect »

Clinical Trials at Myovant

Sarasota
Sarasota, FL United States
  Connect »

Clinical Trials at Myovant

Stuart
Stuart, FL United States
  Connect »

Clinical Trials at Myovant

Wellington
Wellington, FL United States
  Connect »

Clinical Trials at Myovant

Atlanta
Atlanta, GA United States
  Connect »

Clinical Trials at Myovant

Decatur
Decatur, GA United States
  Connect »

Clinical Trials at Myovant

Norcross
Norcross, GA United States
  Connect »

Clinical Trials at Myovant

Sandy Springs
Sandy Springs, GA United States
  Connect »

Clinical Trials at Myovant

Savannah
Savannah, GA United States
  Connect »

Clinical Trials at Myovant

Idaho Falls
Idaho Falls, ID United States
  Connect »

Clinical Trials at Myovant

Champaign
Champaign, IL United States
  Connect »

Clinical Trials at Myovant

Naperville
Naperville, IL United States
  Connect »

Clinical Trials at Myovant

Avon
Avon, IN United States
  Connect »

Clinical Trials at Myovant

Shawnee
Shawnee Mission, KS United States
  Connect »

Clinical Trials at Myovant

Marrero
Marrero, LA United States
  Connect »

Clinical Trials at Myovant

Metairie
Metairie, LA United States
  Connect »

Clinical Trials at Myovant

Baltimore
Baltimore, MD United States
  Connect »

Clinical Trials at Myovant

Canton
Canton, MI United States
  Connect »

Clinical Trials at Myovant

Saginaw
Saginaw, MI United States
  Connect »

Clinical Trials at Myovant

Norfolk
Norfolk, NE United States
  Connect »

Clinical Trials at Myovant

Las Vegas
Las Vegas, NV United States
  Connect »

Clinical Trials at Myovant

Albuquerque
Albuquerque, NM United States
  Connect »

Clinical Trials at Myovant

Brooklyn
Brooklyn, NY United States
  Connect »

Clinical Trials at Myovant

New York
New York, NY United States
  Connect »

Clinical Trials at Myovant

Rochester
Rochester, NY United States
  Connect »

Clinical Trials at Myovant

Raleigh
Raleigh, NC United States
  Connect »

Clinical Trials at Myovant

Winston Salem
Winston-Salem, NC United States
  Connect »

Clinical Trials at Myovant

Cincinnati
Cincinnati, OH United States
  Connect »

Clinical Trials at Myovant

Columbus
Columbus, OH United States
  Connect »

Clinical Trials at Myovant

West Reading
West Reading, PA United States
  Connect »

Clinical Trials at Myovant

Dallas
Dallas, TX United States
  Connect »

Clinical Trials at Myovant

Fort Worth
Fort Worth, TX United States
  Connect »

Clinical Trials at Myovant

Frisco
Frisco, TX United States
  Connect »

Clinical Trials at Myovant

Houston
Houston, TX United States
  Connect »

Clinical Trials at Myovant

Longview
Longview, TX United States
  Connect »

Clinical Trials at Myovant

San Antonio
San Antonio, TX United States
  Connect »

Clinical Trials at Myovant

Virginia Beach
Virginia Beach, VA United States
  Connect »

Clinical Trials at Myovant

Covington
Covington, WA United States
  Connect »

Clinical Trials at Myovant

Puyallup
Puyallup, WA United States
  Connect »

Clinical Trials at Myovant

Spokane
Spokane, WA United States
  Connect »

Clinical Trials at Myovant

Brussels
Brussels, Belgium
  Connect »

Clinical Trials at Myovant

Debrecen
Debrecen, Hungary
  Connect »

Clinical Trials at Myovant

Budapest
Budapest, Hungary
  Connect »

Clinical Trials at Myovant

Canoga Park
Canoga Park, CA United States
  Connect »

Clinical Trials at Myovant

Panorama
Panorama City, CA United States
  Connect »

Clinical Trials at Myovant

Lake City
Lake City, FL United States
  Connect »

Clinical Trials at Myovant

Miami
Miami, FL United States
  Connect »

Clinical Trials at Myovant

Tampa
Tampa, FL United States
  Connect »

Clinical Trials at Myovant

Nampa
Nampa, ID United States
  Connect »

Clinical Trials at Myovant

Chicago
Chicago, IL United States
  Connect »

Clinical Trials at Myovant

New Brunswick
New Brunswick, NJ United States
  Connect »

Clinical Trials at Myovant

La Louvi re
La Louvière, Belgium
  Connect »

Clinical Trials at Myovant

Ny regyh za
Nyíregyháza, Hungary
  Connect »

Clinical Trials at Myovant

Kecskem t
Kecskemét, Hungary
  Connect »