Phase 3
N=477
LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Heavy Menstrual Bleeding · Uterine Fibroid
Bottom Line
View on ClinicalTrials.gov: NCT03412890 ↗Enrolled (actual)
477
Serious AEs
3.6%
Results posted
May 2024
Primary outcome: Primary: 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 — 86.50; 79.87; 75.00 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Relugolix (Drug); Estradiol/norethindrone acetate (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Myovant Sciences GmbH
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
86.50; 79.87; 75.00 | — |
| SECONDARY Change From Pivotal Study Baseline In MBL Volume At Week 52 |
-251.6; -219.1; -204.7 | — |
| SECONDARY Percentage Of Participants Who Achieved Or Maintained Amenorrhea Over The Last 35 Days Of Treatment |
70.55; 68.46; 57.93 | — |
| SECONDARY 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 |
58.97; 78.95; 42.11 | — |
| SECONDARY 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 |
56; 60; 45 | — |
| SECONDARY Change From Pivotal Study Baseline In Hemoglobin Concentration At Week 52 |
2.7; 3.0; 1.9 | — |
| SECONDARY Change From Pivotal Study Baseline In The UFS-QoL Symptom Severity Scale At Week 52 |
-37.3; -38.2; -35.0 | — |
| SECONDARY Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 |
56.4; 56.4; 51.2; 47.8; 46.9; 45.2 | — |
| SECONDARY Change From Pivotal Study Baseline In The UFS-QoL Score By Health-Related Quality of Life Total Score At Week 52 |
40.4; 41.7; 39.0 | — |
| SECONDARY 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 |
-51.3; -51.6; -48.6 | — |
| SECONDARY Change From Pivotal Study Baseline In Uterine Volume At Week 52 |
-73.31; -91.67; -37.62 | — |
| SECONDARY Change From Pivotal Study Baseline In Uterine Fibroid Volume At Week 52 |
-31.84; -28.18; -17.07 | — |
| SECONDARY 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 |
-0.804; -2.045; -0.775; -0.153; -0.842; -0.065 | — |
| SECONDARY Change From Pivotal Study Baseline In Predose Serum E2 Concentrations At Week 52 |
-21.83; -33.77; -29.99 | — |
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).
Eligibility Criteria
Key Inclusion Criteria
- Completed 24 weeks of study drug treatment and study participation in either pivotal study, MVT-601-3001 or MVT-601-3002
Key Exclusion Criteria
- 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)
- Met a withdrawal criterion in the pivotal study (MVT-601-3001 or MVT-601-3002).
Data sourced from ClinicalTrials.gov (NCT03412890). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.