Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
An International Phase 3 Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
2 other identifiers
interventional
229
8 countries
104
Brief Summary
The objectives of this randomized withdrawal study are to evaluate the long-term efficacy and safety of the combination of relugolix, estradiol (E2) and norethindrone acetate (NETA), once daily, for up to 104 weeks in patients with uterine fibroids who have completed a total of 52 weeks of treatment, including a 24-week treatment period in a parent study (study MVT-601-3001 or MVT-601-3002) and a 28-week treatment period in the open-label extension study (MVT-601-3003), and who meet the definition of responder, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2018
Typical duration for phase_3
104 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 16, 2018
CompletedFirst Submitted
Initial submission to the registry
November 13, 2018
CompletedFirst Posted
Study publicly available on registry
November 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2021
CompletedResults Posted
Study results publicly available
June 25, 2024
CompletedJune 25, 2024
May 1, 2024
2.3 years
November 13, 2018
August 26, 2022
May 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage Of Participants Who Maintained MBL Volume Of <80 Milliliters (mL) At Week 76 During The Randomized Treatment Period
MBL volume is measured using the alkaline hematin method. The method involves pummeling used feminine products in a 5% sodium hydroxide solution, which leads to the conversion of hemoglobin to alkaline hematin. The volume of MBL is measured in mL and a blood loss of 80 mL or more per cycle is considered diagnostic of heavy menstrual bleeding. The sustained responder rate was calculated as the Kaplan-Meier estimate of the cumulative probability of MBL volume \< 80 mL through Week 76 using the Kaplan-Meier method.
Week 52/Baseline up to Week 76
Secondary Outcomes (47)
Time To MBL Volume ≥80 mL During The Randomized Treatment Period
From Week 52/Baseline through Week 104
Percentage Of Participants Who Maintained MBL Volume Of <80 mL At Week 104 During The Randomized Treatment Period
Week 52/Baseline up to Week 104
Percentage Of Participants Achieving Or Maintaining Amenorrhea At Week 76 During The Randomized Treatment Period
Week 76
Change From Week 52/Baseline To Week 76 In MBL Volume During The Randomized Treatment Period
Week 52/Baseline to Week 76
Change From Week 52/Baseline To Week 104 In MBL Volume During The Randomized Treatment Period
Week 52/Baseline to Week 104
- +42 more secondary outcomes
Study Arms (2)
Relugolix plus E2/NETA
EXPERIMENTALRelugolix 40 mg co-administered with estradiol (1.0 mg) and norethindrone acetate (0.5 mg) for up to 52 weeks.
Placebo tablets and capsules
PLACEBO COMPARATOR* 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.
Interventions
Relugolix 40 mg tablet administered orally once daily
Capsule containing co-formulated tablet of estradiol 1.0 mg and norethindrone acetate 0.5 mg administered orally once daily
Placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor
Placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor
Eligibility Criteria
You may qualify if:
- Completed the open-label extension study (MVT-601-3003).
- 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.
- Is not expected to undergo gynecological surgery or ablation procedures for uterine fibroids within the study period
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 Parent study or extension study.
- Has a weight that exceeds the weight limit of the dual-energy x-ray absorptiometry (DXA) scanner
- Has developed any contraindication to treatment with estradiol or norethindrone acetate
- Is currently pregnant or lactating, or intends to become pregnant during the study period
- Met a withdrawal criterion in the open-label extension (OLE) study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (104)
Birmingham
Birmingham, Alabama, 35205, United States
Mesa
Mesa, Arizona, 85209, United States
Tucson
Tucson, Arizona, 85712, 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
Los Angeles
Los Angeles, California, 90057, United States
Norwalk
Norwalk, California, 90650, United States
San Diego
San Diego, California, 92111, United States
Denver
Denver, Colorado, 80209, United States
Lakewood
Lakewood, Colorado, 80228, 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
Jacksonville
Jacksonville, Florida, 32207, United States
Jupiter
Jupiter, Florida, 33458, 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
Orlando
Orlando, Florida, 33759, United States
Oviedo
Oviedo, Florida, 32765, United States
Sarasota
Sarasota, Florida, 34239, United States
Tampa
Tampa, Florida, 33613, United States
United States, Florida
West Palm Beach, Florida, 33409, United States
West Palm Beach
West Palm Beach, Florida, 33409, United States
Weston
Weston, Florida, 33327, United States
Atlanta
Atlanta, Georgia, 30342, United States
Augusta
Augusta, Georgia, 30912, United States
College Park
College Park, Georgia, 30349, United States
Dacatur
Decatur, Georgia, 30034, United States
Duluth
Duluth, Georgia, 30097, United States
Norcross
Norcross, Georgia, 30093, United States
Savannah
Savannah, Georgia, 31406, United States
Smyrna
Smyrna, Georgia, 30080, United States
Chicago
Chicago, Illinois, 60611, United States
Oak brook
Oak Brook, 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, 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
Las Vegas
Las Vegas, Nevada, 89109, United States
Las Vegas
Las Vegas, Nevada, 89128, United States
Lawrenceville
Lawrenceville, New Jersey, 08648, 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, 45219, 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
Dallas
Dallas, Texas, 75231, United States
Houston
Houston, Texas, 77030, United States
Houston
Houston, Texas, 77054, United States
Longview
Longview, Texas, 75605, United States
San Antonio
San Antonio, Texas, 78229, United States
San Antonio
San Antonio, Texas, 78258, United States
Webster
Webster, Texas, 77598, United States
Norfolk
Norfolk, Virginia, 23507, United States
Richmond
Richmond, Virginia, 23225, United States
Spokane
Spokane, Washington, 99207, United States
Porto Alegre
Porto Alegre, Rio Grande do Sul, 90510-040, Brazil
São Bernardo do Campo
São Bernardo do Campo, São Paulo, 09715-090, Brazil
Sao Paulo
São Paulo, São Paulo, 01317-000, Brazil
Porto Alegre
Porto Alegre, 90510-040, Brazil
São Paulo
São Paulo, 04266-010, Brazil
Providencia
Providencia, 7510186, Chile
San Ramon
San Ramón, 8880465, Chile
Santiago
Santiago, 8360160, Chile
České Budějovice
České Budějovice, 370 01, Czechia
Olomouc
Olomouc, 772 00, Czechia
Pisek
Písek, 39701, Czechia
Kecskemét
Kecskemét, Bács-Kiskun county, 6000, Hungary
Debrecen
Debrecen, 4024, Hungary
Debrecen
Debrecen, 4025, Hungary
Gyula
Gyula, 5700, Hungary
Nyíregyháza
Nyíregyháza, 4400, Hungary
Szentes
Szentes, 6600, Hungary
Catanzaro
Catanzaro, 88100, Italy
Roma
Roma, 00168, Italy
SIENA
Siena, 53100, Italy
Torino
Torino, 10126, Italy
Szczecin
Szczecin, West Pomeranian Voivodeship, 71-270, Poland
Bialystok
Bialystok, 15-464, Poland
Katowice
Katowice, 40-123, Poland
Poznan
Poznan, 60-192, Poland
Warszawa
Warsaw, 02-201, Poland
Bloemfontein
Bloemfontein, Free State, 9301, South Africa
Centurion
Centurion, Gauteng, 0157, South Africa
Cape Town
Cape Town, Western Cape, 7405, South Africa
Cape Town
Cape Town, Western Cape, 7500, South Africa
Durban
Durban, 4126, South Africa
Roodepoort
Roodepoort, 1724, South Africa
Related Publications (1)
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.
PMID: 37666383DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials at Myovant
- Organization
- Myovant Sciences GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2018
First Posted
November 23, 2018
Study Start
October 16, 2018
Primary Completion
February 19, 2021
Study Completion
October 20, 2021
Last Updated
June 25, 2024
Results First Posted
June 25, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share