Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
NCT ID: NCT03751124
Last Updated: 2024-06-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
229 participants
INTERVENTIONAL
2018-10-16
2021-10-20
Brief Summary
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Detailed Description
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Approximately 360 women with heavy menstrual bleeding associated with uterine fibroids completing the extension study with a response to treatment will be eligible to participate in this study. A responder is defined as a patient who demonstrates a menstrual blood loss of \< 80 mL and at least a 50% reduction from parent study baseline menstrual blood loss volume on the alkaline hematin analysis of the feminine products returned at Week 48 in the extension study.
Screening procedures will be done on the same day as the Week 52 visit for the extension study. This visit will be referred to as the "Week 52/Baseline visit." When the Week 52/Baseline procedures in the extension study have been completed, the investigator will assess patient eligibility for participation in this study. The eligibility assessment will be based on data available at the Week 52/Baseline visit.
Patients will be asked to provide feminine products for alkaline hematin analysis at each visit until the analysis confirms the return of heavy menstrual bleeding. The patients will then be offered retreatment with open-label relugolix with E2/NETA with the onset of the next menses. They will resume collection of feminine products for alkaline hematin analysis until two consecutive analyses confirm resolution of heavy menstrual bleeding (menstrual blood loss of \< 80 mL). Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, clinical laboratory tests, and assessments of bone mineral density.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Relugolix plus E2/NETA
Relugolix 40 mg co-administered with estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 52 weeks.
Relugolix
Relugolix 40 mg tablet administered orally once daily
Estradiol/norethindrone acetate
Capsule containing co-formulated tablet of estradiol 1.0 mg and norethindrone acetate 0.5 mg administered orally once daily
Placebo tablets and capsules
* Placebo for relugolix co-administered with placebo for E2/NETA for up to 52 weeks or until heavy menstrual bleeding returns.
* Retreatment with open-label relugolix with E2/NETA will be offered if heavy menstrual bleeding returns.
Placebo for relugolix
Placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor
Placebo for E2/NETA
Placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor
Interventions
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Relugolix
Relugolix 40 mg tablet administered orally once daily
Estradiol/norethindrone acetate
Capsule containing co-formulated tablet of estradiol 1.0 mg and norethindrone acetate 0.5 mg administered orally once daily
Placebo for relugolix
Placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor
Placebo for E2/NETA
Placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Is a responder: Has a menstrual blood loss of \< 80 mL AND at least a 50% reduction from the parent study Baseline based on the results of the alkaline hematin testing performed on the feminine products returned at the Week 48 visit of the extension study.
3. Is not expected to undergo gynecological surgery or ablation procedures for uterine fibroids within the study period
Exclusion Criteria
2. Has a weight that exceeds the weight limit of the dual-energy x-ray absorptiometry (DXA) scanner
3. Has developed any contraindication to treatment with estradiol or norethindrone acetate
4. Is currently pregnant or lactating, or intends to become pregnant during the study period
5. Met a withdrawal criterion in the open-label extension (OLE) study.
18 Years
51 Years
FEMALE
No
Sponsors
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Myovant Sciences GmbH
INDUSTRY
Responsible Party
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Locations
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Birmingham
Birmingham, Alabama, United States
Mesa
Mesa, Arizona, United States
Tucson
Tucson, Arizona, United States
Canoga Park
Canoga Park, California, United States
Huntington Beach
Huntington Beach, California, United States
La Mesa
La Mesa, California, United States
Los Angeles
Los Angeles, California, United States
Norwalk
Norwalk, California, United States
San Diego
San Diego, California, United States
Denver
Denver, Colorado, United States
Lakewood
Lakewood, Colorado, 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
Jacksonville
Jacksonville, Florida, United States
Jupiter
Jupiter, Florida, United States
Margate
Margate, Florida, United States
Miami
Miami, Florida, United States
Miami
Miami, Florida, United States
Miami
Miami, Florida, United States
Orlando
Orlando, Florida, United States
Oviedo
Oviedo, Florida, United States
Sarasota
Sarasota, Florida, United States
Tampa
Tampa, Florida, United States
United States, Florida
West Palm Beach, Florida, United States
West Palm Beach
West Palm Beach, Florida, United States
Weston
Weston, Florida, United States
Atlanta
Atlanta, Georgia, United States
Augusta
Augusta, Georgia, United States
College Park
College Park, Georgia, United States
Dacatur
Decatur, Georgia, United States
Duluth
Duluth, Georgia, United States
Norcross
Norcross, Georgia, United States
Savannah
Savannah, Georgia, United States
Smyrna
Smyrna, Georgia, United States
Chicago
Chicago, Illinois, United States
Oak brook
Oak Brook, Illinois, United States
Shawnee
Shawnee Mission, Kansas, United States
Covington
Covington, Louisiana, United States
Marrero
Marrero, 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
Las Vegas
Las Vegas, Nevada, United States
Las Vegas
Las Vegas, Nevada, United States
Lawrenceville
Lawrenceville, New Jersey, 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
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
Dallas
Dallas, 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
Webster
Webster, Texas, United States
Norfolk
Norfolk, Virginia, United States
Richmond
Richmond, Virginia, United States
Spokane
Spokane, Washington, United States
Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
São Bernardo do Campo
São Bernardo do Campo, São Paulo, Brazil
Sao Paulo
São Paulo, São Paulo, Brazil
Porto Alegre
Porto Alegre, , Brazil
São Paulo
São Paulo, , Brazil
Providencia
Providencia, , Chile
San Ramon
San Ramón, , Chile
Santiago
Santiago, , Chile
České Budějovice
České Budějovice, , Czechia
Olomouc
Olomouc, , Czechia
Pisek
Písek, , Czechia
Kecskemét
Kecskemét, Bács-Kiskun county, Hungary
Debrecen
Debrecen, , Hungary
Debrecen
Debrecen, , Hungary
Gyula
Gyula, , Hungary
Nyíregyháza
Nyíregyháza, , Hungary
Szentes
Szentes, , Hungary
Catanzaro
Catanzaro, , Italy
Roma
Roma, , Italy
SIENA
Siena, , Italy
Torino
Torino, , Italy
Szczecin
Szczecin, West Pomeranian Voivodeship, Poland
Bialystok
Bialystok, , Poland
Katowice
Katowice, , Poland
Poznan
Poznan, , Poland
Warszawa
Warsaw, , Poland
Bloemfontein
Bloemfontein, Free State, South Africa
Centurion
Centurion, Gauteng, South Africa
Cape Town
Cape Town, Western Cape, South Africa
Cape Town
Cape Town, Western Cape, South Africa
Durban
Durban, , South Africa
Roodepoort
Roodepoort, , South Africa
Countries
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References
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Al-Hendy A, Venturella R, Arjona Ferreira JC, Li Y, Soulban G, Wagman RB, Lukes AS. LIBERTY randomized withdrawal study: relugolix combination therapy for heavy menstrual bleeding associated with uterine fibroids. Am J Obstet Gynecol. 2023 Dec;229(6):662.e1-662.e25. doi: 10.1016/j.ajog.2023.08.030. Epub 2023 Sep 2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-001368-43
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MVT-601-035
Identifier Type: -
Identifier Source: org_study_id
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