Trial · NCT03412890
LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
NCT03412890, Phase 3, Completed, Myovant Sciences GmbH; results first posted 2024-05-09
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids. Trials, record NCT03412890. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03412890
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
- NCT number
- NCT03412890
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 477 participants, actual
- Lead sponsor
- Myovant Sciences GmbH
- Conditions
- Heavy Menstrual Bleeding, Uterine Fibroid
- Interventions
- Relugolix, Estradiol/norethindrone acetate
- First posted
- 2018-01-29
- Last updated
- 2024-05-09
- Other registries' IDs
- eudract:2017-003310-74
- Results first posted
- 2024-05-09
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Week 52/End of Treatment | A responder was a participant who had MBL volume of \< 80 mL and at least a 50% reduction from baseline MBL volume over the last 35 days of treatment (up to Week 52). All returned feminine products collected at each clinical visit were analyzed by the alkaline hematin method to obtain the MBL volume. MBL volume was measured over the Week 52/early termination feminine product collection interval (up to 35 days prior to the last dose of treatment). The percentage of participants who were responders are presented. |
| Secondary | Change From Pivotal Study Baseline In MBL Volume At Week 52 | Week 52 | MBL volume was measured using the alkaline hematin method, which involves chemically measuring the blood content of used feminine products. 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 least squares (LS) mean was derived for each treatment group using a mixed-effects model with repeated measure with visit, region, and Baseline MBL as fixed effects. |
| Secondary | Percentage Of Participants Who Achieved Or Maintained Amenorrhea Over The Last 35 Days Of Treatment | Week 24 up to last 35 days of treatment (up to Week 52) | Amenorrhea was defined as meeting 1 of the following criteria for 2 consecutive visits: * No feminine product returned due to reported amenorrhea; * No feminine product returned due to reports of spotting/negligible bleeding coupled with other data (participant's paper diary) indicating infrequent non-cyclic bleeding/spotting; and * Feminine product collection with a negligible observed MBL volume coupled with data (participant's paper diary) indicating infrequent non-cyclic bleeding/spotting. |
| 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 | Week 52 | Blood samples were collected from participants for hemoglobin measurements. Percentages are based on number of participants with hemoglobin ≤10.5 g/dL at pivotal study Baseline and reported at Week 52. |
| 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 | Week 52 | Blood samples were collected from participants for hemoglobin measurements. Percentages are based on number of participants with hemoglobin concentration below the lower limit of normal (11.6 g/dL) at pivotal study Baseline and reported at Week 52. |
| Secondary | Change From Pivotal Study Baseline In Hemoglobin Concentration At Week 52 | Week 52 | Blood samples were collected from participants for hemoglobin measurements. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure. |
| Secondary | Change From Pivotal Study Baseline In The UFS-QoL Symptom Severity Scale At Week 52 | Week 52 | Transformed score ranges from 0 to 100 based on Likert scale (none of time, a little of time, some of the time, most of the time, and all of the time). Lower score indicates less distress and higher score indicates greater distress. A negative change from baseline indicates improvement. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure. |
| Secondary | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Week 52 | Assessed using the UFS-QoL questionnaire. The UFS-QoL subscale scores include items related to uterine fibroid-associated limitations/impairment in activities, revised activities, concern, energy/mood, control, self-consciousness, and sexual function. The scores were transformed to normalized scores. Transformed score ranges from 0 to 100. Higher scores are indicative of better health-related quality of life (high = good). The LS mean was derived for each treatment group using a mixed-effects model with repeated measure. |
| Secondary | Change From Pivotal Study Baseline In The UFS-QoL Score By Health-Related Quality of Life Total Score At Week 52 | Week 52 | Assessed using the UFS-QoL Questionnaire. The UFS-QoL total score was the sum of the subscales (concern, activities, revised activities, energy/mood, control, self-conscious, and sexual function). The raw scores were transformed to normalized scores. Transformed score ranges from 0 to 100. Higher scores are indicative of better health-related quality of life (high = good). The LS mean was derived for each treatment group using a mixed-effects model with repeated measure. |
| 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 | Week 52 | The BPD scale has been derived from the UFS-QoL symptom severity scale. The scale consists of the following 3 symptoms proximal to uterine fibroids that are experienced by most participants: heavy bleeding during the menstrual period (Question 1), passing blood clots during the menstrual period (Question 2), and feeling tightness or pressure in the pelvic area (Question 5). Raw scores were transformed to a normalized score, with a range of possible scores from 0 to 100 (none of time, a little of time, some of the time, most of the time, and all of the time), where higher scores values are indicative of greater distress and lower scores are indicative of minimal distress. The LS mean was derived for each treatment group using a mixed-effects model with repeated measure. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Week 52/End of Treatment | Extension Study Population: all participants who enrolled and received any amount of open-label study drug in the open-label extension study. | percentage of participants | NUMBER |
| SECONDARY | Change From Pivotal Study Baseline In MBL Volume At Week 52 | Week 52 | Extension Study Population: all participants who enrolled and received any amount of open-label study drug in the open-label extension study. | mL | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Of Participants Who Achieved Or Maintained Amenorrhea Over The Last 35 Days Of Treatment | Week 24 up to last 35 days of treatment (up to Week 52) | Extension Study Population: all participants who enrolled and received any amount of open-label study drug in the open-label extension study. | percentage of participants | NUMBER |
| 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 | Week 52 | Extension Study Population with a hemoglobin level ≤10.5 g/dL at pivotal study baseline: all participants who enrolled and received any amount of open-label study drug in the open-label extension study and who had a hemoglobin level ≤10.5 g/dL at pivotal study baseline. | percentage of participants | NUMBER |
| 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 | Week 52 | Extension Study Population with a hemoglobin level below lower limit of normal at pivotal study baseline: all participants who enrolled and received any amount of open-label study drug in the open-label extension study and who had a hemoglobin level below lower limit of normal at pivotal study baseline. | participants | NUMBER |
| SECONDARY | Change From Pivotal Study Baseline In Hemoglobin Concentration At Week 52 | Week 52 | Extension Study Population with a hemoglobin level ≤10.5 g/dL at pivotal study baseline: all participants who enrolled and received any amount of open-label study drug in the open-label extension study and who had a hemoglobin level ≤10.5 g/dL at pivotal study baseline. | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Pivotal Study Baseline In The UFS-QoL Symptom Severity Scale At Week 52 | Week 52 | Extension Study Population: all participants who enrolled and received any amount of open-label study drug in the open-label extension study. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Pivotal Study Baseline In The UFS-QoL Score Health-Related Quality of Life Subscales Score At Week 52 | Week 52 | Extension Study Population: all participants who enrolled and received any amount of open-label study drug in the open-label extension study. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Pivotal Study Baseline In The UFS-QoL Score By Health-Related Quality of Life Total Score At Week 52 | Week 52 | Extension Study Population: all participants who enrolled and received any amount of open-label study drug in the open-label extension study. | score on a scale | LEAST_SQUARES_MEAN |
| 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 | Week 52 | Extension Study Population: all participants who enrolled and received any amount of open-label study drug in the open-label extension study. | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group201
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Relugolix Plus E2/NETA (Group A) | 86.50 | 95% Confidence Interval 80.28 to 91.34 | percentage of participants | |
| 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 | Relugolix Plus Delayed E2/NETA (Group B) | 79.87 | 95% Confidence Interval 72.52 to 85.98 | percentage of participants | |
| 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 | Placebo (Group C) | 75.00 | 95% Confidence Interval 67.65 to 81.42 | percentage of participants | |
| Change From Pivotal Study Baseline In MBL Volume At Week 52 | Relugolix Plus E2/NETA (Group A) | -251.6 | Standard Error 16.38 | mL | |
| Change From Pivotal Study Baseline In MBL Volume At Week 52 | Relugolix Plus Delayed E2/NETA (Group B) | -219.1 | Standard Error 13.91 | mL | |
| Change From Pivotal Study Baseline In MBL Volume At Week 52 | Placebo (Group C) | -204.7 | Standard Error 13.31 | mL | |
| Percentage Of Participants Who Achieved Or Maintained Amenorrhea Over The Last 35 Days Of Treatment | Relugolix Plus E2/NETA (Group A) | 70.55 | 95% Confidence Interval 62.92 to 77.42 | percentage of participants | |
| Percentage Of Participants Who Achieved Or Maintained Amenorrhea Over The Last 35 Days Of Treatment | Relugolix Plus Delayed E2/NETA (Group B) | 68.46 | 95% Confidence Interval 60.35 to 75.82 | percentage of participants | |
| Percentage Of Participants Who Achieved Or Maintained Amenorrhea Over The Last 35 Days Of Treatment | Placebo (Group C) | 57.93 | 95% Confidence Interval 49.98 to 65.58 | percentage of participants | |
| 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 | Relugolix Plus E2/NETA (Group A) | 58.97 | 95% Confidence Interval 42.10 to 74.43 | percentage of participants |
1 to 10 of 201Source ClinicalTrials.gov
See all 201 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Relugolix Plus E2/NETA (Group A) | 163 | |
| Overall Study | STARTED | Relugolix Plus Delayed E2/NETA (Group B) | 150 | |
| Overall Study | STARTED | Placebo (Group C) | 164 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Relugolix Plus E2/NETA (Group A) | 163 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Relugolix Plus Delayed E2/NETA (Group B) | 149 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo (Group C) | 164 | |
| Overall Study | COMPLETED | Relugolix Plus E2/NETA (Group A) | 133 | |
| Overall Study | COMPLETED | Relugolix Plus Delayed E2/NETA (Group B) | 108 | |
| Overall Study | COMPLETED | Placebo (Group C) | 122 | |
| Overall Study | NOT COMPLETED | Relugolix Plus E2/NETA (Group A) | 30 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events66
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Relugolix Plus E2/NETA (Group A) | 6 | 163 | |
| other | Headache | Nervous system disorders | Relugolix Plus Delayed E2/NETA (Group B) | 7 | 149 | |
| other | Headache | Nervous system disorders | Placebo (Group C) | 11 | 164 | |
| other | Hot flush | Vascular disorders | Relugolix Plus E2/NETA (Group A) | 4 | 163 | |
| other | Hot flush | Vascular disorders | Relugolix Plus Delayed E2/NETA (Group B) | 0 | 149 | |
| other | Hot flush | Vascular disorders | Placebo (Group C) | 13 | 164 | |
| other | Nasopharyngitis | Infections and infestations | Relugolix Plus E2/NETA (Group A) | 10 | 163 | |
| other | Nasopharyngitis | Infections and infestations | Relugolix Plus Delayed E2/NETA (Group B) | 3 | 149 | |
| other | Nasopharyngitis | Infections and infestations | Placebo (Group C) | 8 | 164 | |
| other | Hypertension | Vascular disorders | Relugolix Plus E2/NETA (Group A) | 2 | 163 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Relugolix Plus E2/NETA (Group A) | 0 | 163 |
| Total, all-cause mortality | Relugolix Plus Delayed E2/NETA (Group B) | 0 | 149 |
| Total, all-cause mortality | Placebo (Group C) | 0 | 164 |
| Total, other adverse events | Relugolix Plus E2/NETA (Group A) | 22 | 163 |
| Total, other adverse events | Relugolix Plus Delayed E2/NETA (Group B) | 12 | 149 |
| Total, other adverse events | Placebo (Group C) | 38 | 164 |
| Total, serious adverse events | Relugolix Plus E2/NETA (Group A) | 1 | 163 |
| Total, serious adverse events | Relugolix Plus Delayed E2/NETA (Group B) | 5 | 149 |
| Total, serious adverse events | Placebo (Group C) | 11 | 164 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03412890
GET https://conductscience.org/api/trials/v1/NCT03412890/results?page=2