LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
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
2 other identifiers
interventional
477
9 countries
150
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2017
Typical duration for phase_3
150 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 19, 2017
CompletedFirst Submitted
Initial submission to the registry
January 19, 2018
CompletedFirst Posted
Study publicly available on registry
January 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2021
CompletedResults Posted
Study results publicly available
May 9, 2024
CompletedMay 9, 2024
April 1, 2024
2.3 years
January 19, 2018
November 13, 2023
April 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage Of Participants Who Achieved Or Maintained An MBL Volume Of <80 Milliliters (mL) And At Least A 50% Reduction From Baseline MBL Volume At Week 52/End Of Treatment
A responder was a participant who had MBL volume of \< 80 mL and at least a 50% reduction from baseline MBL volume over the last 35 days of treatment (up to Week 52). All returned feminine products collected at each clinical visit were analyzed by the alkaline hematin method to obtain the MBL volume. MBL volume was measured over the Week 52/early termination feminine product collection interval (up to 35 days prior to the last dose of treatment). The percentage of participants who were responders are presented.
Week 52/End of Treatment
Secondary Outcomes (13)
Change From Pivotal Study Baseline In MBL Volume At Week 52
Week 52
Percentage Of Participants Who Achieved Or Maintained Amenorrhea Over The Last 35 Days Of Treatment
Week 24 up to last 35 days of treatment (up to Week 52)
Percentage Of Participants With A Hemoglobin Level ≤10.5 Gram/Deciliter (g/dL) At Pivotal Study Baseline Who Achieved An Increase Of >2 g/dL From Pivotal Study Baseline At Week 52
Week 52
Number Of Participants With Hemoglobin Increase Of ≥1 g/dL From Pivotal Study Baseline At Week 52 Among Those With A Hemoglobin Concentration Below Lower Limit Of Normal At Pivotal Baseline
Week 52
Change From Pivotal Study Baseline In Hemoglobin Concentration At Week 52
Week 52
- +8 more secondary outcomes
Other Outcomes (1)
Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52
Week 52
Study Arms (1)
Relugolix plus E2/NETA
EXPERIMENTALRelugolix co-administered with E2/NETA for 28 weeks.
Interventions
Relugolix 40-mg tablet administered orally once daily
Capsule containing co-formulated tablet of E2 (1 mg) and NETA (0.5 mg) administered orally once daily
Eligibility Criteria
You may qualify if:
- \. Completed 24 weeks of study drug treatment and study participation in either pivotal study, MVT-601-3001 or MVT-601-3002
You may not qualify if:
- Has undergone myomectomy, ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids, uterine artery embolization, magnetic resonance-guided focused ultrasound for fibroids, or endometrial ablation for abnormal uterine bleeding at any time during the pivotal study (MVT-601-3001 or MVT-601-3002)
- Met a withdrawal criterion in the pivotal study (MVT-601-3001 or MVT-601-3002).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (150)
Andalusia
Andalusia, Alabama, 36420, United States
Birmingham
Birmingham, Alabama, 35205, United States
Mobile
Mobile, Alabama, 36608, United States
Mesa
Mesa, Arizona, 85209, United States
Tucson
Tucson, Arizona, 85712, United States
Little Rock
Little Rock, Arkansas, 72204, United States
Canoga Park
Canoga Park, California, 91303, United States
Huntington Beach
Huntington Beach, California, 92647, United States
La Mesa
La Mesa, California, 91942, United States
Long Beach
Long Beach, California, 90806, United States
Los Angeles
Los Angeles, California, 90036, United States
Los Angeles
Los Angeles, California, 90057, United States
Norwalk
Norwalk, California, 90650, United States
Panorama
Panorama City, California, 91402, United States
San Diego
San Diego, California, 92108, United States
San Diego
San Diego, California, 92111, United States
Denver
Denver, Colorado, 80209, United States
Lakewood
Lakewood, Colorado, 80228, United States
Washington
Washington D.C., District of Columbia, 20036, United States
Aventura
Aventura, Florida, 33180, United States
Clearwater
Clearwater, Florida, 33759, United States
DeLand
DeLand, Florida, 32720, United States
Ft. Lauderdale
Fort Lauderdale, Florida, 33316, United States
Fort Myers
Fort Myers, Florida, 33912, United States
Hialeah
Hialeah, Florida, 33016, United States
Jacksonville
Jacksonville, Florida, 32207, United States
Jupiter
Jupiter, Florida, 33458, United States
Loxahatchee
Loxahatchee Groves, Florida, 33470, United States
Margate
Margate, Florida, 33063, United States
Miami
Miami, Florida, 33126, United States
Miami
Miami, Florida, 33155, United States
Miami
Miami, Florida, 33165, United States
New Port Richey
New Port Richey, Florida, 34652, United States
Orlando
Orlando, Florida, 32808, United States
Oviedo
Oviedo, Florida, 32765, United States
Palm Harbor
Palm Harbor, Florida, 34684, United States
Saint Cloud
Saint Cloud, Florida, 34769, United States
Sarasota
Sarasota, Florida, 34239, United States
Tampa
Tampa, Florida, 33606, United States
Tampa
Tampa, Florida, 33613, United States
West Palm Beach
West Palm Beach, Florida, 33409, United States
Weston
Weston, Florida, 33327, United States
Atlanta
Atlanta, Georgia, 30342, United States
Atlanta
Atlanta, Georgia, 30363, United States
Augusta
Augusta, Georgia, 30904, United States
College Park
College Park, Georgia, 30349, United States
Decatur
Decatur, Georgia, 30034, United States
Duluth
Duluth, Georgia, 30097, United States
Norcross
Norcross, Georgia, 30093, United States
Savannah
Savannah, Georgia, 31406, United States
Chicago
Chicago, Illinois, 60611, United States
Naperville
Naperville, Illinois, 60540, United States
Oakbrook
Oakbrook Terrace, Illinois, 60523, United States
Shawnee
Shawnee Mission, Kansas, 66218, United States
Covington
Covington, Louisiana, 70433, United States
Marrero
Marrero, Louisiana, 70072, United States
Metairie
Metairie, Louisiana, 70001, United States
Metairie
Metairie, Louisiana, 70006, United States
Baltimore
Baltimore, Maryland, 21208, United States
Towson
Towson, Maryland, 21204, United States
Canton
Canton, Michigan, 48187, United States
Detroit
Detroit, Michigan, 48201, United States
Saginaw
Saginaw, Michigan, 48604, United States
Lincoln
Lincoln, Nebraska, 68510, United States
Las Vegas
Las Vegas, Nevada, 89109, United States
Las Vegas
Las Vegas, Nevada, 89113, United States
Las Vegas
Las Vegas, Nevada, 89128, United States
Lawrenceville
Lawrenceville, New Jersey, 08648, United States
Albuquerque
Albuquerque, New Mexico, 87102, United States
Brooklyn
Brooklyn, New York, 11201, United States
New York
New York, New York, 10022, United States
Williamsville
Williamsville, New York, 14221, United States
Durham
Durham, North Carolina, 27713, United States
Raleigh
Raleigh, North Carolina, 27607, United States
Raleigh
Raleigh, North Carolina, 27612, United States
Winston-Salem
Winston-Salem, North Carolina, 27103, United States
Cincinnati
Cincinnati, Ohio, 45212, United States
Cincinnati
Cincinnati, Ohio, 45219, United States
Columbus
Columbus, Ohio, 43231, United States
Englewood
Englewood, Ohio, 45322, United States
Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Bluffton
Bluffton, South Carolina, 29910, United States
Charleston
Charleston, South Carolina, 29406, United States
Columbia
Columbia, South Carolina, 29201, United States
Chattanooga
Chattanooga, Tennessee, 37404, United States
Memphis
Memphis, Tennessee, 38119, United States
Memphis
Memphis, Tennessee, 38120, United States
Beaumont
Beaumont, Texas, 77702, United States
Dallas
Dallas, Texas, 75231, United States
Fort Worth
Fort Worth, Texas, 76104, United States
Houston
Houston, Texas, 77030, United States
Houston
Houston, Texas, 77054, United States
Houston
Houston, Texas, 77074, United States
Longview
Longview, Texas, 75605, United States
San Antonio
San Antonio, Texas, 78229, United States
San Antonio
San Antonio, Texas, 78258, United States
Sugar Land
Sugar Land, Texas, 77479, United States
Webster
Webster, Texas, 77598, United States
Salt Lake City
Salt Lake City, Utah, 84107, United States
Salt Lake City
Salt Lake City, Utah, 84124, United States
Norfolk
Norfolk, Virginia, 23502, United States
Norfolk
Norfolk, Virginia, 23507, United States
Richmond
Richmond, Virginia, 23225, United States
Spokane
Spokane, Washington, 99207, United States
La Louvière
La Louvière, Hainaut, 7100, Belgium
Gent
Ghent, Oost-vlaanderen, 9000, Belgium
Brussels
Brussels, 1200, Belgium
Jette
Jette, 1090, Belgium
Santo Andre
Santo André, Santo Andre, 09190-510, Brazil
Santo André
Santo André, São Paulo, 09190-510, Brazil
São Bernardo Do Campo
São Bernardo do Campo, São Paulo, 09715-090, Brazil
Sao Paulo
São Paulo, São Paulo, 01317-000, Brazil
Sao Paulo
São Paulo, São Paulo, 04266-010, Brazil
Botucatu
Botucatu, 18618-686, Brazil
Porto Alegre
Porto Alegre, 90035-903, Brazil
Porto Alegre
Porto Alegre, 90510-040, Brazil
Providencia
Providencia, 7510186, Chile
San Ramon
San Ramón, 8880465, Chile
Region Metropolitana
Santiago, 8320165, Chile
Santiago
Santiago, 8360160, Chile
Ceské Budejovice
České Budějovice, 370 01, Czechia
Jihlava
Jihlava, 586 33, Czechia
Olomouc
Olomouc, 772 00, Czechia
Pisek
Písek, 39701, Czechia
Gyula
Gyula, Bekes County, 5700, Hungary
Kecskemét
Kecskemét, Bács-Kiskun county, 6000, Hungary
Debrecen
Debrecen, Hajdú-Bihar, 4024, Hungary
Nyíregyháza
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary
Debrecen
Debrecen, 4025, Hungary
Szentes
Szentes, 6600, Hungary
Catanzaro
Catanzaro, 88100, Italy
Firenze
Florence, 50134, Italy
Roma
Roma, 00168, Italy
Siena
Siena, 53100, Italy
Torino
Torino, 10126, Italy
Poznan
Poznan, Greater Poland Voivodeship, 60-192, Poland
Skórzewo
Skórzewo, Greater Poland Voivodeship, 60-185, Poland
Lublin
Lublin, Lublin Voivodeship, 20-632, Poland
Warszawa
Warsaw, Masovian Voivodeship, 02-201, Poland
Katowice
Katowice, Silesian Voivodeship, 40-123, Poland
Szczecin
Szczecin, West Pomeranian Voivodeship, 71-270, Poland
Bialystok
Bialystok, 15-464, Poland
Lódz
Lódz, Łódź Voivodeship, 90-602, Poland
Centurion
Centurion, Gauteng, 0157, South Africa
Roodepoort
Roodepoort, Gauteng, 1724, South Africa
Durban
Durban, KwaZulu-Natal, 4001, South Africa
Bloemfontein
Bloemfontein, 9301, South Africa
Cape Town
Cape Town, 7405, South Africa
Cape Town
Cape Town, 7500, South Africa
Port Elizabeth
Port Elizabeth, 6001, South Africa
Related Publications (3)
Stewart EA, Al-Hendy A, Lukes AS, Madueke-Laveaux OS, Zhu E, Proehl S, Schulmann T, Marsh EE. Relugolix combination therapy in Black/African American women with symptomatic uterine fibroids: LIBERTY Long-Term Extension study. Am J Obstet Gynecol. 2024 Feb;230(2):237.e1-237.e11. doi: 10.1016/j.ajog.2023.10.030. Epub 2023 Oct 18.
PMID: 37863160DERIVEDAl-Hendy A, Lukes AS, Venturella R, Villarroel C, McKain L, Li Y, Wagman RB, Stewart EA. A plain language summary of the long-term relugolix combination therapy study for uterine fibroids. J Comp Eff Res. 2023 Aug;12(8):e230069. doi: 10.57264/cer-2023-0069. Epub 2023 Jul 21.
PMID: 37477173DERIVEDAl-Hendy A, Lukes AS, Poindexter AN 3rd, Venturella R, Villarroel C, McKain L, Li Y, Wagman RB, Stewart EA. Long-term Relugolix Combination Therapy for Symptomatic Uterine Leiomyomas. Obstet Gynecol. 2022 Dec 1;140(6):920-930. doi: 10.1097/AOG.0000000000004988. Epub 2022 Nov 2.
PMID: 36357960DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials at Myovant
- Organization
- Myovant Sciences GmbH
Study Officials
- STUDY DIRECTOR
Myovant Medical Monitor
Myovant Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2018
First Posted
January 29, 2018
Study Start
October 19, 2017
Primary Completion
January 21, 2020
Study Completion
January 13, 2021
Last Updated
May 9, 2024
Results First Posted
May 9, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share