Clinical trial NCT03412890: LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Official title: LIBERTY EXTENSION: An International Phase 3 Open-Label, Single-Arm, Long-Term Efficacy and Safety Extension Study to Evaluate Relugolix Co-Administered With Low-Dose Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heavy Menstrual Bleeding
Uterine Fibroid
Keywords: Uterine Fibroid
Heavy Menstrual Bleeding
Menstrual Blood Volume
Lead sponsor: Myovant Sciences GmbH
Sponsor class: INDUSTRY
First posted: 2018-01-29
Enrollment: 477
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-Label Extension
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the long-term efficacy and safety of relugolix 40 milligrams (mg) once daily co-administered with estradiol (E2) and norethindrone acetate (NETA) for 28 weeks on heavy menstrual bleeding associated with uterine fibroids in participants who previously completed a 24-week treatment period in one of the pivotal studies (MVT-601-3001 or MVT-601-3002).

Detailed description: This study is an international phase 3 open-label, single-arm, long-term efficacy and safety extension study that enrolled eligible participants who have completed their participation in one of the phase 3 randomized, double-blind, placebo-controlled pivotal studies, MVT-601-3001 (LIBERTY 1 - NCT03049735) or MVT-601-3002 (LIBERTY 2 - NCT 03103087). All participants received relugolix 40 mg orally once daily co-administered with E2 (1 mg) and NETA (0.5 mg) for 28 weeks.

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.

Eligibility criteria: Key Inclusion Criteria:

1. Completed 24 weeks of study drug treatment and study participation in either pivotal study, MVT-601-3001 or MVT-601-3002

Key Exclusion Criteria:

1. 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 pivotal study (MVT-601-3001 or MVT-601-3002)
2. Met a withdrawal criterion in the pivotal study (MVT-601-3001 or MVT-601-3002).

Primary outcomes:
measure: Percentage Of Participants Who Achieved Or Maintained An MBL Volume Of <80 Milliliters (mL) And At Least A 50% Reduction From Baseline MBL Volume At Week 52/End Of Treatment
timeFrame: Week 52/End of Treatment
Secondary outcomes:
measure: Change From Pivotal Study Baseline In MBL Volume At Week 52
timeFrame: Week 52
measure: Percentage Of Participants Who Achieved Or Maintained Amenorrhea Over The Last 35 Days Of Treatment
timeFrame: Week 24 up to last 35 days of treatment (up to Week 52)
measure: Percentage Of Participants With A Hemoglobin Level ≤10.5 Gram/Deciliter (g/dL) At Pivotal Study Baseline Who Achieved An Increase Of >2 g/dL From Pivotal Study Baseline At Week 52
timeFrame: Week 52
measure: Number Of Participants With Hemoglobin Increase Of ≥1 g/dL From Pivotal Study Baseline At Week 52 Among Those With A Hemoglobin Concentration Below Lower Limit Of Normal At Pivotal Baseline
timeFrame: Week 52
measure: Change From Pivotal Study Baseline In Hemoglobin Concentration At Week 52
timeFrame: Week 52
measure: Change From Pivotal Study Baseline In The UFS-QoL Symptom Severity Scale At Week 52
timeFrame: Week 52
measure: Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52
timeFrame: Week 52
measure: Change From Pivotal Study Baseline In The UFS-QoL Score By Health-Related Quality of Life Total Score At Week 52
timeFrame: Week 52
measure: Change From Pivotal Study Baseline In The Uterine Fibroid Symptom Health-Related Quality of Life (UFS-QoL) Bleeding And Pelvic Discomfort (BPD) Scale At Week 52
timeFrame: Week 52
measure: Change From Pivotal Study Baseline In Uterine Volume At Week 52
timeFrame: Week 52
measure: Change From Pivotal Study Baseline In Uterine Fibroid Volume At Week 52
timeFrame: Week 52
measure: Percent Change From Pivotal Study Baseline In Bone Mineral Density (BMD) At The Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52
timeFrame: Week 52
measure: Change From Pivotal Study Baseline In Predose Serum E2 Concentrations At Week 52
timeFrame: Week 52
Other outcomes:
measure: Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) Scale At Week 52
timeFrame: Week 52
Locations:
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country: Czechia
facility: Ceské Budejovice
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country: Hungary
facility: Kecskemét
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facility: Gyula
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country: Hungary
facility: Debrecen
state: Hajdu-bihar
city: Nyíregyháza
country: Hungary
facility: Nyíregyháza
state: Szabolcs-Szatmar-Bereg
city: Debrecen
country: Hungary
facility: Debrecen
city: Szentes
country: Hungary
facility: Szentes
city: Catanzaro
country: Italy
facility: Catanzaro
city: Firenze
country: Italy
facility: Firenze
city: Roma
country: Italy
facility: Roma
city: Siena
country: Italy
facility: Siena
city: Torino
country: Italy
facility: Torino
city: Lódz
country: Poland
facility: Lódz
state: Lodzkie
city: Lublin
country: Poland
facility: Lublin
state: Lubelskie
city: Warszawa
country: Poland
facility: Warszawa
state: Mazowieckie
city: Katowice
country: Poland
facility: Katowice
state: Slaskie
city: Poznań
country: Poland
facility: Poznan
state: Wielkopolskie
city: Skórzewo
country: Poland
facility: Skórzewo
state: Wielkopolskie
city: Szczecin
country: Poland
facility: Szczecin
state: Zachodniopomorskie
city: Białystok
country: Poland
facility: Bialystok
city: Centurion
country: South Africa
facility: Centurion
state: Gauteng
city: Roodepoort
country: South Africa
facility: Roodepoort
state: Gauteng
city: Durban
country: South Africa
facility: Durban
state: Kwazulu-natal
city: Bloemfontein
country: South Africa
facility: Bloemfontein
city: Cape Town
country: South Africa
facility: Cape Town
city: Cape Town
country: South Africa
facility: Cape Town
city: Port Elizabeth
country: South Africa
facility: Port Elizabeth
Study officials:
affiliation: Myovant Sciences
name: Myovant Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.