LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
NCT ID: NCT03103087
Last Updated: 2022-04-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
382 participants
INTERVENTIONAL
2017-06-14
2020-09-16
Brief Summary
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LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
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Detailed Description
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All participants completing the Week 24 visit, including participants 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.
Relugolix placebo
Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
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.
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.
Relugolix placebo
Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
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.
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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Birmingham
Birmingham, Alabama, United States
Mesa
Mesa, Arizona, United States
Tucson
Tucson, Arizona, United States
Tuscon
Tucson, Arizona, United States
Canoga Park
Canoga Park, California, United States
Huntington Beach
Huntington Beach, California, United States
Long Beach
Long Beach, California, United States
Los Angeles
Los Angeles, California, United States
Los Angeles
Los Angeles, California, United States
Panorama
Panorama City, California, United States
San Diego
San Diego, California, United States
Upland
Upland, 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
DeLand
DeLand, Florida, United States
Ft. Lauderdale
Fort Lauderdale, Florida, United States
Jupiter
Jupiter, Florida, United States
Lake City
Lake City, Florida, United States
Loxahachee
Loxahatchee Groves, Florida, United States
Miami
Miami, Florida, United States
Miami
Miami, Florida, United States
Miami Springs
Miami Springs, Florida, United States
New Port Richey
New Port Richey, Florida, United States
North Miami
North Miami, Florida, United States
Oviedo
Oviedo, Florida, United States
Plantation
Plantation, Florida, United States
Port St. Lucie
Port Saint Lucie, Florida, United States
Saint Cloud
Saint Cloud, Florida, United States
Sarasota
Sarasota, Florida, United States
Stuart
Stuart, Florida, United States
Tampa
Tampa, Florida, United States
Wellington
Wellington, Florida, United States
West Palm Beach
West Palm Beach, Florida, United States
Atlanta
Atlanta, Georgia, United States
Decatur
Decatur, Georgia, United States
Duluth
Duluth, Georgia, United States
Norcross
Norcross, Georgia, United States
Sandy Springs
Sandy Springs, Georgia, United States
Savannah
Savannah, Georgia, United States
Idaho Falls
Idaho Falls, Idaho, United States
Nampa
Nampa, Idaho, United States
Champaign
Champaign, Illinois, United States
Chicago
Chicago, Illinois, United States
Naperville
Naperville, Illinois, United States
Oakbrook
Oak Brook, Illinois, United States
Avon
Avon, Indiana, United States
Shawnee
Shawnee Mission, Kansas, United States
Marrero
Marrero, Louisiana, United States
Metairie
Metairie, Louisiana, United States
New Orleans
New Orleans, Louisiana, United States
Baltimore
Baltimore, Maryland, United States
Towson
Towson, Maryland, United States
Bay City
Bay City, Michigan, United States
Canton
Canton, Michigan, United States
Detroit
Detroit, Michigan, United States
Saginaw
Saginaw, Michigan, United States
Norfolk
Norfolk, Nebraska, United States
Las Vegas
Las Vegas, Nevada, United States
Las Vegas
Las Vegas, Nevada, United States
Las Vegas
Las Vegas, Nevada, United States
New Brunswick
New Brunswick, New Jersey, United States
Albuquerque
Albuquerque, New Mexico, United States
Brooklyn
Brooklyn, New York, United States
New York
New York, New York, United States
New York
New York, New York, United States
Rochester
Rochester, New York, United States
Durham
Durham, North Carolina, United States
Raleigh
Raleigh, North Carolina, United States
Winston Salem
Winston-Salem, North Carolina, United States
Cincinnati
Cincinnati, Ohio, United States
Columbus
Columbus, Ohio, United States
West Reading
West Reading, Pennsylvania, United States
Charleston
Charleston, South Carolina, United States
Beaumont
Beaumont, Texas, United States
Dallas
Dallas, Texas, United States
Dallas
Dallas, Texas, United States
Fort Worth
Fort Worth, Texas, United States
Frisco
Frisco, 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
Virginia Beach
Norfolk, Virginia, United States
Richmond
Richmond, Virginia, United States
Covington
Covington, Washington, United States
Puyallup
Puyallup, Washington, United States
Spokane
Spokane, Washington, United States
Brussels
Brussels, , Belgium
Brussels
Brussels, , Belgium
Ghent
Ghent, , Belgium
Jette
Jette, , Belgium
La Louvière
La Louvière, , Belgium
Botucatu
Botucatu, , Brazil
Porto Alegre
Porto Alegre, , Brazil
Porto Alegre
Porto Alegre, , Brazil
São Paulo
São Paulo, , Brazil
Santiago
Santiago, Providencia, Chile
San Ramon
San Ramón, , Chile
Santiago
Santiago, , Chile
Santiago
Santiago, , Chile
Ceské Budejovice
České Budějovice, , Czechia
Jihlava
Jihlava, , Czechia
Nachod
Náchod, , Czechia
Olomouc
Olomouc, , Czechia
Ostrava
Ostrava, , Czechia
Pisek
Písek, , Czechia
Debrecen
Debrecen, Hajdu, Hungary
Nyíregyháza
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Budapest
Budapest, , Hungary
Debrecen
Debrecen, , Hungary
Gyula
Gyula, , Hungary
Kecskemét
Kecskemét, , Hungary
Pecs
Pécs, , Hungary
Szentes
Szentes, , Hungary
Poznan
Poznan, Greater Poland Voivodeship, Poland
Krakow
Krakow, Lesser Poland Voivodeship, Poland
Rzeszów
Rzeszów, Masovian Voivodeship, Poland
Białystok
Bialystok, Podlaskie Voivodeship, Poland
Bialystok
Bialystok, Podlaskie Voivodeship, Poland
Katowice
Katowice, Silesian Voivodeship, Poland
Gdańsk
Gdansk, , Poland
Cape Town
Cape Town, Western Cape, South Africa
Bloemfontein
Bloemfontein, , South Africa
Centurion
Centurion, , South Africa
Parow
Parow, , South Africa
Countries
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References
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Catherino WH, Al-Hendy A, Zaim S, Bouzegaou N, Venturella R, Stewart EA, Wu R, Vannuccini S, Perry JS, Rakov VG, Munro MG. Efficacy and safety of relugolix combination therapy in women with uterine fibroids and adenomyosis: subgroup analysis of LIBERTY 1 and LIBERTY 2. Fertil Steril. 2025 Sep;124(3):523-533. doi: 10.1016/j.fertnstert.2025.04.037. Epub 2025 May 2.
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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2016-005113-50
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MVT-601-3002
Identifier Type: -
Identifier Source: org_study_id
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