LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
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ClinicalTrials.gov Identifier: NCT03103087 |
Recruitment Status :
Completed
First Posted : April 6, 2017
Results First Posted : April 20, 2022
Last Update Posted : April 20, 2022
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Sponsor:
Myovant Sciences GmbH
Information provided by (Responsible Party):
Myovant Sciences GmbH
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Conditions |
Heavy Menstrual Bleeding Uterine Fibroid |
Interventions |
Drug: Relugolix Drug: Estradiol/norethindrone acetate Drug: Relugolix placebo Drug: Estradiol/norethindrone acetate placebo |
Enrollment | 382 |
Participant Flow
Recruitment Details | The study was conducted at 99 study centers throughout the world, including centers in the United States, Belgium, Brazil, Chile, Czech Republic, Hungary, Poland, and South Africa. |
Pre-assignment Details | A total of 382 premenopausal women aged 18 to 50 years old (inclusive) with heavy menstrual bleeding (≥ 160 milliliters [mL] during 1 cycle or ≥ 80 mL per cycle for 2 menstrual cycles as measured by the alkaline hematin method) associated with uterine fibroids were randomized. One participant was randomized in error before eligibility confirmed. |
Arm/Group Title | Relugolix Plus Estradiol (E2])/Norethindrone Acetate (NETA) (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) |
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Relugolix 40 milligrams (mg) co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks. | Relugolix 40 mg co-administered with placebo for E2/NETA for 12 weeks followed by relugolix 40 mg co-administered with E2/NETA (1.0/0.5 mg) for 12 weeks. | Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks. |
Period Title: Overall Study | |||
Started | 126 | 127 | 129 |
Completed | 102 | 98 | 102 |
Not Completed | 24 | 29 | 27 |
Reason Not Completed | |||
Did not receive any study drug | 1 | 0 | 0 |
Protocol Violation | 1 | 2 | 1 |
Lack of Efficacy | 2 | 1 | 1 |
Pregnancy | 0 | 0 | 1 |
Adverse Event | 2 | 15 | 6 |
Withdrawal by Subject | 13 | 6 | 6 |
Lost to Follow-up | 4 | 2 | 7 |
Other reason not reported | 1 | 3 | 5 |
Baseline Characteristics
Arm/Group Title | Relugolix Plus E2/NETA (Group A) | Relugolix Plus Delayed E2/NETA (Group B) | Placebo (Group C) | Total | |
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Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks. | Relugolix 40 mg co-administered with placebo for E2/NETA for 12 weeks followed by relugolix 40 mg co-administered with E2/NETA (1.0/0.5 mg) for 12 weeks. | Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks | Total of all reporting groups | |
Overall Number of Baseline Participants | 126 | 127 | 129 | 382 | |
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All participants who were enrolled and randomized in the study.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 126 participants | 127 participants | 129 participants | 382 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Between 18 and 65 years |
126 100.0%
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127 100.0%
|
129 100.0%
|
382 100.0%
|
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>=65 years |
0 0.0%
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0 0.0%
|
0 0.0%
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0 0.0%
|
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 126 participants | 127 participants | 129 participants | 382 participants | |
42.4 (5.37) | 42.1 (5.25) | 41.8 (5.26) | 42.1 (5.29) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 126 participants | 127 participants | 129 participants | 382 participants | |
Female |
126 100.0%
|
127 100.0%
|
129 100.0%
|
382 100.0%
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|
Male |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 126 participants | 127 participants | 129 participants | 382 participants | |
Hispanic or Latino |
18 14.3%
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34 26.8%
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32 24.8%
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84 22.0%
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Not Hispanic or Latino |
106 84.1%
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91 71.7%
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96 74.4%
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293 76.7%
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Unknown or Not Reported |
2 1.6%
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2 1.6%
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1 0.8%
|
5 1.3%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 126 participants | 127 participants | 129 participants | 382 participants | |
American Indian or Alaska Native |
0 0.0%
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2 1.6%
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1 0.8%
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3 0.8%
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|
Asian |
0 0.0%
|
3 2.4%
|
1 0.8%
|
4 1.0%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
63 50.0%
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66 52.0%
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74 57.4%
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203 53.1%
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White |
58 46.0%
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50 39.4%
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49 38.0%
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157 41.1%
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More than one race |
1 0.8%
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1 0.8%
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0 0.0%
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2 0.5%
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Unknown or Not Reported |
4 3.2%
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5 3.9%
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4 3.1%
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13 3.4%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 126 participants | 127 participants | 129 participants | 382 participants |
Hungary | 7 | 7 | 8 | 22 | |
Belgium | 0 | 3 | 1 | 4 | |
United States | 94 | 94 | 96 | 284 | |
Czechia | 4 | 2 | 3 | 9 | |
Poland | 7 | 6 | 4 | 17 | |
Brazil | 1 | 3 | 1 | 5 | |
South Africa | 7 | 3 | 7 | 17 | |
Chile | 6 | 9 | 9 | 24 | |
Mean MBL Volume
Mean (Standard Deviation) Unit of measure: mL |
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Number Analyzed | 126 participants | 127 participants | 129 participants | 382 participants | |
247.62 (185.553) | 227.41 (34.350) | 211.75 (129.903) | 228.45 (152.205) |
Outcome Measures
Adverse Events
Limitations and Caveats
None reported
More Information
Results Point of Contact
Name/Title: | Clinical Trials at Myovant |
Organization: | Myovant Sciences GmbH |
Phone: | +1 650 238 0250 |
EMail: | clinicaltrials@myovant.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Myovant Sciences GmbH |
ClinicalTrials.gov Identifier: | NCT03103087 |
Other Study ID Numbers: |
MVT-601-3002 2016-005113-50 ( EudraCT Number ) |
First Submitted: | February 8, 2017 |
First Posted: | April 6, 2017 |
Results First Submitted: | March 23, 2022 |
Results First Posted: | April 20, 2022 |
Last Update Posted: | April 20, 2022 |