LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
NCT ID: NCT03049735
Last Updated: 2022-04-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
388 participants
INTERVENTIONAL
2017-04-26
2020-08-24
Brief Summary
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Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
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Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
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Detailed Description
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All participants completing the Week 24 visit, including women randomized to placebo, were offered the opportunity to enroll in an open-label extension study in which all eligible participants will receive relugolix co-administered with low-dose E2 and NETA. Participants who did not enroll into the extension study had a follow-up visit approximately 30 days after the end of treatment (that is, after the participant's last dose of study medication).
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Relugolix plus E2/NETA (Group A)
Relugolix co-administered with E2/NETA for 24 weeks.
Relugolix
Relugolix (40 mg) tablet administered orally once daily.
Estradiol/norethindrone acetate
E2 (1.0 mg)/NETA (0.5 mg) co-formulated capsule administered orally once daily.
Relugolix plus Delayed E2/NETA (Group B)
Relugolix co-administered with E2/NETA placebo for 12 weeks, followed by relugolix co-administered with E2/NETA for 12 weeks.
Relugolix
Relugolix (40 mg) tablet administered orally once daily.
Estradiol/norethindrone acetate
E2 (1.0 mg)/NETA (0.5 mg) co-formulated capsule administered orally once daily.
Estradiol/norethindrone acetate placebo
E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the capsule containing E2/NETA in size, shape, color, and odor.
Placebo (Group C)
Relugolix placebo co-administered with E2/NETA placebo for 24 weeks.
Estradiol/norethindrone acetate placebo
E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the capsule containing E2/NETA in size, shape, color, and odor.
Relugolix placebo
Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
Interventions
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Relugolix
Relugolix (40 mg) tablet administered orally once daily.
Estradiol/norethindrone acetate
E2 (1.0 mg)/NETA (0.5 mg) co-formulated capsule administered orally once daily.
Estradiol/norethindrone acetate placebo
E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the capsule containing E2/NETA in size, shape, color, and odor.
Relugolix placebo
Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Has regularly occurring menstrual periods of ≤ 14 days duration with a cycle of 21 to 38 days from the start of 1 menstrual period until the start of the next, by participant history for at least 3 months prior to the first screening visit.
3. Has a diagnosis of uterine fibroids that is confirmed by a transvaginal and/or transabdominal ultrasound performed during the screening period.
4. Has heavy menstrual bleeding associated with uterine fibroids as evidenced by an MBL of ≥ 160 milliliter (mL) during 1 cycle or ≥ 80 mL per cycle for 2 menstrual cycles as measured by the alkaline hematin method during the screening period.
Exclusion Criteria
2. Has known rapidly enlarging uterine fibroids in the opinion of the investigator.
3. Has a weight that exceeds the weight limit of the DXA scanner or has a condition that precludes an adequate DXA measurement at the lumbar spine and proximal femur.
4. Has a history of or currently has osteoporosis, or other metabolic bone disease, hyperparathyroidism, hyperprolactinemia, hyperthyroidism, anorexia nervosa, or low traumatic (from the standing position) or atraumatic fracture (toe, finger, skull, face and ankle fractures are allowed). A history of successfully treated hyperparathyroidism, hyperprolactinemia, or hyperthyroidism is allowed if the participant's bone mineral density is within normal limits.
5. Has a history of the use of bisphosphonates, calcitonin, calcitriol, ipriflavone, teriparatide, denosumab, or any medication other than calcium and vitamin D preparations to treat bone mineral density loss.
6. Has been a participant in an investigational drug or device study within the 1 month prior to the first screening visit.
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
Mobile
Mobile, Alabama, United States
Little Rock
Little Rock, Arkansas, United States
La Mesa
La Mesa, California, United States
Lomita
Lomita, California, United States
Norwalk
Norwalk, California, United States
Oceanside
Oceanside, California, United States
San Diego
San Diego, California, United States
San Diego
San Diego, California, United States
Denver
Denver, Colorado, United States
Aventura
Aventura, Florida, United States
Brandon
Brandon, Florida, United States
Clearwater
Clearwater, Florida, United States
Clermont
Clermont, Florida, United States
Fort Myers
Fort Myers, Florida, United States
Hialeah
Hialeah, Florida, United States
Hialeah
Hialeah, Florida, United States
Jacksonville
Jacksonville, Florida, United States
Lauderdale Lakes
Lauderdale Lakes, 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
Orlando
Orlando, Florida, United States
Palm Harbor
Palm Harbor, Florida, United States
South Miami
South Miami, 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
Richland
Richland, Georgia, United States
Oakbrook
Oakbrook Terrace, Illinois, United States
Lafayette
Lafayette, Indiana, United States
Covington
Covington, Louisiana, United States
Shreveport
Shreveport, Louisiana, United States
St. Louis
St Louis, Missouri, United States
Lincoln
Lincoln, Nebraska, United States
Omaha
Omaha, Nebraska, 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
Williamsville
Williamsville, New York, United States
Durham
Durham, North Carolina, United States
Morehead City
Morehead City, North Carolina, United States
Raleigh
Raleigh, North Carolina, United States
Bismarck
Bismarck, North Dakota, United States
Fargo
Fargo, North Dakota, United States
Minot
Minot, North Dakota, United States
Cincinnati
Cincinnati, Ohio, United States
Cincinnati
Cincinnati, Ohio, United States
Dayton
Dayton, 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
Greenville
Greenville, South Carolina, United States
Chattanooga
Chattanooga, Tennessee, United States
Memphis
Memphis, Tennessee, United States
Memphis
Memphis, Tennessee, United States
Fort Worth
Fort Worth, Texas, United States
Houston
Houston, Texas, United States
Houston
Houston, Texas, United States
Irving
Irving, 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
Seattle
Seattle, Washington, United States
Curitiba
Curitiba, , Brazil
Porto Alegre
Porto Alegre, , Brazil
Ribeirao Preto
Ribeirão Preto, , Brazil
Santo Andre
Santo André, , Brazil
Sao Paulo
São Paulo, , Brazil
Bologna
Bologna, , Italy
Catanzaro
Catanzaro, , Italy
Fiernze
Florence, , Italy
Genova
Genova, , Italy
Milano
Milan, , Italy
Modena
Modena, , Italy
Monserrato
Monserrato, , Italy
Napoli
Napoli, , Italy
Roma
Roma, , Italy
Roma
Roma, , Italy
Siena
Siena, , Italy
Torino
Torino, , Italy
Katowice
Katowice, , Poland
Lodz
Lodz, , Poland
Lodz
Lodz, , Poland
Lublin
Lublin, , Poland
Lublin
Lublin, , Poland
Poznan
Poznan, , Poland
Szczecin
Szczecin, , Poland
Warszawa
Warsaw, , Poland
Warszawa
Warsaw, , Poland
Durban
Durban, , South Africa
Durban
Durban, , South Africa
Port Elizabeth
Port Elizabeth, , South Africa
Roodepoort
Roodepoort, , South Africa
Birmingham
Birmingham, , United Kingdom
Isleworth
Isleworth, , United Kingdom
London
London, , United Kingdom
Nottingham
Nottingham, , United Kingdom
Countries
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References
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Stewart EA, Lukes AS, Venturella R, Ferreira JA, Li Y, Hunsche E, Wagman RB, Al-Hendy A. A plain language summary describing changes in pain associated with uterine fibroids among women receiving relugolix combination therapy. Pain Manag. 2024 Sep;14(9):469-476. doi: 10.1080/17581869.2024.2408114. Epub 2024 Oct 28.
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, Critchley HO, Li Y, McKain L, Arjona Ferreira JC, Langenberg AG, Wagman RB, Stewart EA. A plain language summary of the safety of relugolix combination therapy and improvement in symptoms in women with uterine fibroids from the LIBERTY 1 and LIBERTY 2 studies. Pain Manag. 2023 Apr;13(4):205-211. doi: 10.2217/pmt-2022-0085. Epub 2023 May 15.
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.
Stewart EA, Lukes AS, Venturella R, Arjona Ferreira JC, Li Y, Hunsche E, Wagman RB, Al-Hendy A. Relugolix Combination Therapy for Uterine Leiomyoma-Associated Pain in the LIBERTY Randomized Trials. Obstet Gynecol. 2022 Jun 1;139(6):1070-1081. doi: 10.1097/AOG.0000000000004787. Epub 2022 May 2.
Hunsche E, Rakov V, Scippa K, Witherspoon B, McKain L. The Burden of Uterine Fibroids from the Perspective of US Women Participating in Open-Ended Interviews. Womens Health Rep (New Rochelle). 2022 Mar 4;3(1):286-296. doi: 10.1089/whr.2021.0086. eCollection 2022.
Al-Hendy A, Lukes AS, Poindexter AN 3rd, Venturella R, Villarroel C, Critchley HOD, Li Y, McKain L, Arjona Ferreira JC, Langenberg AGM, Wagman RB, Stewart EA. Treatment of Uterine Fibroid Symptoms with Relugolix Combination Therapy. N Engl J Med. 2021 Feb 18;384(7):630-642. doi: 10.1056/NEJMoa2008283.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003727-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MVT-601-3001
Identifier Type: -
Identifier Source: org_study_id
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