LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
NCT ID: NCT03412890
Last Updated: 2024-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
477 participants
INTERVENTIONAL
2017-10-19
2021-01-13
Brief Summary
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Detailed Description
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Approximately 600 women with heavy menstrual bleeding associated with uterine fibroids were to be enrolled, after having completed a 24-week treatment period in one of the pivotal studies. The objectives of the study were to evaluate long-term efficacy and safety through up to 52 weeks of treatment (including treatment during the pivotal study) of relugolix co-administered with E2/NETA.
Screening and baseline procedures were to be done at the same visit for this extension study (referred to as the "Week 24/Baseline Visit"), which coincided with the Week 24 Visit from the pivotal study and was to be defined as the date of completion of the last Week 24 procedure in the pivotal study. Participants will have received their last dose of study drug in the pivotal study on the day prior to the Week 24/Baseline Visit and were to receive their first dose of study drug for this extension study in the clinic after the participant was determined to be eligible for this extension study and provided informed consent to participate. The administration of the first dose of study drug for MVT-601-3003 was to define enrollment into this study. Study participants were to then take the open-label study treatment orally once daily for 28 weeks.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Relugolix plus E2/NETA
Relugolix co-administered with E2/NETA for 28 weeks.
Relugolix
Relugolix 40-mg tablet administered orally once daily
Estradiol/norethindrone acetate
Capsule containing co-formulated tablet of E2 (1 mg) and NETA (0.5 mg) administered orally once daily
Interventions
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Relugolix
Relugolix 40-mg tablet administered orally once daily
Estradiol/norethindrone acetate
Capsule containing co-formulated tablet of E2 (1 mg) and NETA (0.5 mg) administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Met a withdrawal criterion in the pivotal study (MVT-601-3001 or MVT-601-3002).
18 Years
50 Years
FEMALE
No
Sponsors
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Myovant Sciences GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Myovant Medical Monitor
Role: STUDY_DIRECTOR
Myovant Sciences
Locations
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Andalusia
Andalusia, Alabama, United States
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
Jacksonville
Jacksonville, Florida, United States
Jupiter
Jupiter, Florida, United States
Loxahatchee
Loxahatchee Groves, Florida, United States
Margate
Margate, Florida, United States
Miami
Miami, Florida, United States
Miami
Miami, Florida, United States
Miami
Miami, Florida, United States
New Port Richey
New Port Richey, Florida, United States
Orlando
Orlando, Florida, United States
Oviedo
Oviedo, Florida, United States
Palm Harbor
Palm Harbor, Florida, United States
Saint Cloud
Saint Cloud, Florida, United States
Sarasota
Sarasota, Florida, United States
Tampa
Tampa, Florida, United States
Tampa
Tampa, Florida, United States
West Palm Beach
West Palm Beach, Florida, United States
Weston
Weston, Florida, United States
Atlanta
Atlanta, Georgia, United States
Atlanta
Atlanta, Georgia, United States
Augusta
Augusta, Georgia, United States
College Park
College Park, Georgia, United States
Decatur
Decatur, Georgia, United States
Duluth
Duluth, Georgia, United States
Norcross
Norcross, Georgia, United States
Savannah
Savannah, Georgia, United States
Chicago
Chicago, Illinois, United States
Naperville
Naperville, Illinois, United States
Oakbrook
Oakbrook Terrace, Illinois, United States
Shawnee
Shawnee Mission, Kansas, United States
Covington
Covington, Louisiana, United States
Marrero
Marrero, Louisiana, United States
Metairie
Metairie, Louisiana, United States
Metairie
Metairie, Louisiana, United States
Baltimore
Baltimore, Maryland, United States
Towson
Towson, Maryland, United States
Canton
Canton, Michigan, United States
Detroit
Detroit, Michigan, United States
Saginaw
Saginaw, Michigan, United States
Lincoln
Lincoln, Nebraska, United States
Las Vegas
Las Vegas, Nevada, United States
Las Vegas
Las Vegas, Nevada, United States
Las Vegas
Las Vegas, Nevada, United States
Lawrenceville
Lawrenceville, New Jersey, United States
Albuquerque
Albuquerque, New Mexico, United States
Brooklyn
Brooklyn, New York, United States
New York
New York, New York, United States
Williamsville
Williamsville, New York, United States
Durham
Durham, North Carolina, United States
Raleigh
Raleigh, North Carolina, United States
Raleigh
Raleigh, North Carolina, United States
Winston-Salem
Winston-Salem, North Carolina, United States
Cincinnati
Cincinnati, Ohio, United States
Cincinnati
Cincinnati, Ohio, United States
Columbus
Columbus, Ohio, United States
Englewood
Englewood, Ohio, United States
Philadelphia
Philadelphia, Pennsylvania, United States
Bluffton
Bluffton, South Carolina, United States
Charleston
Charleston, South Carolina, United States
Columbia
Columbia, South Carolina, United States
Chattanooga
Chattanooga, Tennessee, United States
Memphis
Memphis, Tennessee, United States
Memphis
Memphis, Tennessee, United States
Beaumont
Beaumont, Texas, United States
Dallas
Dallas, Texas, United States
Fort Worth
Fort Worth, Texas, United States
Houston
Houston, Texas, United States
Houston
Houston, Texas, United States
Houston
Houston, Texas, United States
Longview
Longview, Texas, United States
San Antonio
San Antonio, Texas, United States
San Antonio
San Antonio, Texas, United States
Sugar Land
Sugar Land, Texas, United States
Webster
Webster, Texas, United States
Salt Lake City
Salt Lake City, Utah, United States
Salt Lake City
Salt Lake City, Utah, United States
Norfolk
Norfolk, Virginia, United States
Norfolk
Norfolk, Virginia, United States
Richmond
Richmond, Virginia, United States
Spokane
Spokane, Washington, United States
La Louvière
La Louvière, Hainaut, Belgium
Gent
Ghent, Oost-vlaanderen, Belgium
Brussels
Brussels, , Belgium
Jette
Jette, , Belgium
Santo Andre
Santo André, Santo Andre, Brazil
Santo André
Santo André, São Paulo, Brazil
São Bernardo Do Campo
São Bernardo do Campo, São Paulo, Brazil
Sao Paulo
São Paulo, São Paulo, Brazil
Sao Paulo
São Paulo, São Paulo, Brazil
Botucatu
Botucatu, , Brazil
Porto Alegre
Porto Alegre, , Brazil
Porto Alegre
Porto Alegre, , Brazil
Providencia
Providencia, , Chile
San Ramon
San Ramón, , Chile
Region Metropolitana
Santiago, , Chile
Santiago
Santiago, , Chile
Ceské Budejovice
České Budějovice, , Czechia
Jihlava
Jihlava, , Czechia
Olomouc
Olomouc, , Czechia
Pisek
Písek, , Czechia
Gyula
Gyula, Bekes County, Hungary
Kecskemét
Kecskemét, Bács-Kiskun county, Hungary
Debrecen
Debrecen, Hajdú-Bihar, Hungary
Nyíregyháza
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Debrecen
Debrecen, , Hungary
Szentes
Szentes, , Hungary
Catanzaro
Catanzaro, , Italy
Firenze
Florence, , Italy
Roma
Roma, , Italy
Siena
Siena, , Italy
Torino
Torino, , Italy
Poznan
Poznan, Greater Poland Voivodeship, Poland
Skórzewo
Skórzewo, Greater Poland Voivodeship, Poland
Lublin
Lublin, Lublin Voivodeship, Poland
Warszawa
Warsaw, Masovian Voivodeship, Poland
Katowice
Katowice, Silesian Voivodeship, Poland
Szczecin
Szczecin, West Pomeranian Voivodeship, Poland
Bialystok
Bialystok, , Poland
Lódz
Lódz, Łódź Voivodeship, Poland
Centurion
Centurion, Gauteng, South Africa
Roodepoort
Roodepoort, Gauteng, South Africa
Durban
Durban, KwaZulu-Natal, South Africa
Bloemfontein
Bloemfontein, , South Africa
Cape Town
Cape Town, , South Africa
Cape Town
Cape Town, , South Africa
Port Elizabeth
Port Elizabeth, , South Africa
Countries
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References
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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.
Al-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.
Al-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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-003310-74
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MVT-601-3003
Identifier Type: -
Identifier Source: org_study_id
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