Trial · NCT03103087
LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
NCT03103087, Phase 3, Completed, Myovant Sciences GmbH; results first posted 2022-04-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids. Trials, record NCT03103087. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03103087
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
- NCT number
- NCT03103087
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 382 participants, actual
- Lead sponsor
- Myovant Sciences GmbH
- Conditions
- Heavy Menstrual Bleeding, Uterine Fibroid
- Interventions
- Relugolix, Estradiol/norethindrone acetate, Relugolix placebo, Estradiol/norethindrone acetate placebo
- First posted
- 2017-04-06
- Last updated
- 2022-04-20
- Other registries' IDs
- eudract:2016-005113-50
- Results first posted
- 2022-04-20
- Limitations and caveats
- None reported
Source ClinicalTrials.gov
Registered outcomes44
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And A ≥ 50% Reduction From Baseline MBL Volume With Relugolix Plus E2/NETA | From Baseline up to the last 35 days of treatment (up to Week 24) | 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 24). 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 24/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. As per the objective of the study, the pre-specified primary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. |
| Secondary | Percentage Of Participants With Amenorrhea Over The Last 35 Days Of Treatment | From Baseline up to last 35 days of treatment (up to Week 24) | 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 electronic diary (e-Diary) data indicating infrequent non-cyclic bleeding/spotting; * Feminine product collection with a negligible observed MBL volume coupled with e-Diary data indicating infrequent non-cyclic bleeding/spotting. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. |
| Secondary | Percent Change From Baseline At Week 24 In MBL Volume | Baseline, Week 24 | MBL volume was measured using the alkaline hematin method. Least square (LS) means for test of difference is Relugolix plus E2/NETA minus Placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. |
| Secondary | Percentage Of Participants With A Hemoglobin Level ≤ 10.5 g/dL At Baseline Who Achieved An Increase Of > 2 g/dL From Baseline At Week 24 | From Baseline up to Week 24 | Blood samples were collected from participants for hemoglobin measurements. Percentages are based on number of participants with hemoglobin ≤ 10.5 gram (g)/deciliter (dL) at Baseline and reported at Week 24. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA with placebo arms are presented. |
| Secondary | Percentage Of Participants With A Maximum Numerical Rating Scale (NRS) Score ≤ 1 For Uterine Fibroid-Associated Pain Over The Last 35 Days Of Treatment | From Baseline up to Week 24 | Uterine fibroid-associated pain was assessed by a pain numerical rating scale (NRS). The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain). Participants were asked to document, in an e-Diary, the worst pain associated with their uterine fibroids that they experienced during the last 24 hours, every day until the end of study drug administration. Pain evaluable participants, defined as those who had maximum NRS score ≥ 4 at baseline and had at least 28 days (80% of the last 35 days of treatment) of pain scores recorded in the e-Diary, were analyzed. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. |
| Secondary | Percent Change From Baseline At Week 24 In Primary Uterine Fibroid Volume | Baseline Week 24 | The volume of the primary uterine fibroid was measured by transvaginal or transabdominal ultrasound. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. |
| Secondary | Percent Change From Baseline At Week 24 In Uterine Volume | From Baseline up to Week 24 | The volume of the uterus was measured by transvaginal or transabdominal ultrasound. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. |
| Secondary | Change From Baseline At Week 24 In UFS-QoL Bleeding And Pelvic Discomfort Scale Score As Measured By The UFS-QoL (Q1, Q2, Q5) | Baseline Week 24 | The Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QoL) Bleeding and Pelvic Discomfort (BPD) Scale has been derived from the UFS-QoL Symptoms Scale. The scale consists of the following 3 symptoms proximal to uterine fibroids: Heavy bleeding during your menstrual period (Question \[Q\] 1), passing blood clots during your menstrual period (Q2), and feeling tightness or pressure in your pelvic area (Q5), raw scores were transformed to a normalized score: Transformed Score = \[(Actual raw score - lowest possible raw score)/(Possible raw score range)\]\*100 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 minimal symptom severity and higher score indicates symptom severity. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms |
| Secondary | Percent Change From Baseline At Week 12 In Bone Mineral Density At The Lumbar Spine (L1 to L4) As Assessed By DXA | From Baseline up to Week 12 | Bone mineral density (BMD) was assessed by dual-energy x-ray absorptiometry (DXA) at the lumbar spine (L1, L2, L3, and L4) at Baseline and at Week 12. The scans were read by the central radiology laboratory in accordance with the imaging charter. The same DXA machine was used at the local imaging center at each site and operated in the same scan mode for all images procured for an individual participant. All images were submitted for central reading. The central radiology laboratory collected and evaluated all DXA scans for acceptability and measured BMD. The LS means were based on a mixed-effect model with visit, region, Baseline MBL volume, age at Baseline, body mass index at Baseline, BMD at Baseline, race, and treatment by visit interaction included as fixed effects. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. |
| Secondary | Percent Change From Baseline At Week 24 In Bone Mineral Density At The Lumbar Spine (L1 To L4), Total Hip, And Femoral Neck As Assessed By DXA | Baseline through Week 24 | BMD was assessed by DXA at the lumbar spine (L1, L2, L3, and L4), total hip, and femoral neck (same leg across participants) at Baseline and at Week 24. The scans were read by the central radiology laboratory in accordance with the imaging charter. The same DXA machine was used at the local imaging center at each site and operated in the same scan mode for all images procured for an individual participant. All images were submitted for central reading. The central radiology laboratory collected and evaluated all DXA scans for acceptability and measured BMD. The LS means were based on a mixed-effect model with visit, region, Baseline MBL volume, age at Baseline, body mass index at Baseline, BMD at Baseline, race, and treatment by visit interaction included as fixed effects. For Relugolix plus E2/NETA Lumbar Spine (L1 to L4), number (n)=95. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only rel |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 registered outcomesOutcomes44
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 A Menstrual Blood Loss (MBL) Volume Of < 80 mL And A ≥ 50% Reduction From Baseline MBL Volume With Relugolix Plus E2/NETA | From Baseline up to the last 35 days of treatment (up to Week 24) | All randomized participants who received any amount of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percentage Of Participants With Amenorrhea Over The Last 35 Days Of Treatment | From Baseline up to last 35 days of treatment (up to Week 24) | All randomized participants who received any amount of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline At Week 24 In MBL Volume | Baseline, Week 24 | All randomized participants who received any amount of study drug. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Of Participants With A Hemoglobin Level ≤ 10.5 g/dL At Baseline Who Achieved An Increase Of > 2 g/dL From Baseline At Week 24 | From Baseline up to Week 24 | All randomized participants who received any amount of study drug and had analyzable study data at the specified timepoint. | Percentage of participants | NUMBER |
| SECONDARY | Percentage Of Participants With A Maximum Numerical Rating Scale (NRS) Score ≤ 1 For Uterine Fibroid-Associated Pain Over The Last 35 Days Of Treatment | From Baseline up to Week 24 | All randomized participants who received any amount of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline At Week 24 In Primary Uterine Fibroid Volume | Baseline Week 24 | All randomized participants who received any amount of study drug and had analyzable study data at the specified timepoint. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline At Week 24 In Uterine Volume | From Baseline up to Week 24 | All participants who were randomized to treatment and who received at least 1 dose of study drug and had evaluable data at the specified timepoint. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline At Week 24 In UFS-QoL Bleeding And Pelvic Discomfort Scale Score As Measured By The UFS-QoL (Q1, Q2, Q5) | Baseline Week 24 | All randomized participants who received any amount of study drug. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline At Week 12 In Bone Mineral Density At The Lumbar Spine (L1 to L4) As Assessed By DXA | From Baseline up to Week 12 | All participants who were randomized to treatment and who received at least 1 dose of study drug and had evaluable data at the specified timepoint. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline At Week 24 In Bone Mineral Density At The Lumbar Spine (L1 To L4), Total Hip, And Femoral Neck As Assessed By DXA | Baseline through Week 24 | All participants who were randomized to treatment and who received at least 1 dose of study drug and had evaluable data at the specified timepoint. | percent change | LEAST_SQUARES_MEAN |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 outcomesResults by group102
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 A Menstrual Blood Loss (MBL) Volume Of < 80 mL And A ≥ 50% Reduction From Baseline MBL Volume With Relugolix Plus E2/NETA | Relugolix Plus E2/NETA (Group A) | 71.2 | 95% Confidence Interval 62.42 to 78.95 | Percentage of participants | |
| Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And A ≥ 50% Reduction From Baseline MBL Volume With Relugolix Plus E2/NETA | Placebo (Group C) | 14.73 | 95% Confidence Interval 9.11 to 22.04 | Percentage of participants | |
| Percentage Of Participants With Amenorrhea Over The Last 35 Days Of Treatment | Relugolix Plus E2/NETA (Group A) | 50.40 | 95% Confidence Interval 41.32 to 59.46 | Percentage of participants | |
| Percentage Of Participants With Amenorrhea Over The Last 35 Days Of Treatment | Placebo (Group C) | 3.10 | 95% Confidence Interval 0.85 to 7.75 | Percentage of participants | |
| Percent Change From Baseline At Week 24 In MBL Volume | Relugolix Plus E2/NETA (Group A) | -84.3 | 95% Confidence Interval -95.0 to -73.6 | percent change | |
| Percent Change From Baseline At Week 24 In MBL Volume | Placebo (Group C) | -15.1 | 95% Confidence Interval -25.8 to -4.3 | percent change | |
| Percentage Of Participants With A Hemoglobin Level ≤ 10.5 g/dL At Baseline Who Achieved An Increase Of > 2 g/dL From Baseline At Week 24 | Relugolix Plus E2/NETA (Group A) | 61.29 | 95% Confidence Interval 42.19 to 78.15 | Percentage of participants | |
| Percentage Of Participants With A Hemoglobin Level ≤ 10.5 g/dL At Baseline Who Achieved An Increase Of > 2 g/dL From Baseline At Week 24 | Placebo (Group C) | 5.41 | 95% Confidence Interval 0.66 to 18.19 | Percentage of participants | |
| Percentage Of Participants With A Maximum Numerical Rating Scale (NRS) Score ≤ 1 For Uterine Fibroid-Associated Pain Over The Last 35 Days Of Treatment | Relugolix Plus E2/NETA (Group A) | 47.06 | 95% Confidence Interval 34.83 to 59.55 | percentage of participants | |
| Percentage Of Participants With A Maximum Numerical Rating Scale (NRS) Score ≤ 1 For Uterine Fibroid-Associated Pain Over The Last 35 Days Of Treatment | Placebo (Group C) | 17.07 | 95% Confidence Interval 9.66 to 26.98 | percentage of participants |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Relugolix Plus Estradiol (E2])/Norethindrone Acetate (NETA) (Group A) | 126 | |
| Overall Study | STARTED | Relugolix Plus Delayed E2/NETA (Group B) | 127 | |
| Overall Study | STARTED | Placebo (Group C) | 129 | |
| Overall Study | COMPLETED | Relugolix Plus Estradiol (E2])/Norethindrone Acetate (NETA) (Group A) | 102 | |
| Overall Study | COMPLETED | Relugolix Plus Delayed E2/NETA (Group B) | 98 | |
| Overall Study | COMPLETED | Placebo (Group C) | 102 | |
| Overall Study | NOT COMPLETED | Relugolix Plus Estradiol (E2])/Norethindrone Acetate (NETA) (Group A) | 24 | |
| Overall Study | NOT COMPLETED | Relugolix Plus Delayed E2/NETA (Group B) | 29 | |
| Overall Study | NOT COMPLETED | Placebo (Group C) | 27 |
Source ClinicalTrials.gov
Adverse events51
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 | Hot flush | Vascular disorders | Relugolix Plus E2/NETA (Group A) | 7 | 126 | 7 |
| other | Hot flush | Vascular disorders | Relugolix Plus Delayed E2/NETA (Group B) | 44 | 126 | 46 |
| other | Hot flush | Vascular disorders | Placebo (Group C) | 5 | 129 | 5 |
| other | Hypertension | Vascular disorders | Relugolix Plus E2/NETA (Group A) | 5 | 126 | 5 |
| other | Hypertension | Vascular disorders | Relugolix Plus Delayed E2/NETA (Group B) | 7 | 126 | 7 |
| other | Hypertension | Vascular disorders | Placebo (Group C) | 4 | 129 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Relugolix Plus E2/NETA (Group A) | 2 | 126 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Relugolix Plus Delayed E2/NETA (Group B) | 2 | 126 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo (Group C) | 7 | 129 | 7 |
| other | Headache | Nervous system disorders | Relugolix Plus E2/NETA (Group A) | 11 | 126 | 15 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 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 | 126 |
| Total, all-cause mortality | Relugolix Plus Delayed E2/NETA (Group B) | 0 | 126 |
| Total, all-cause mortality | Placebo (Group C) | 0 | 129 |
| Total, other adverse events | Relugolix Plus E2/NETA (Group A) | 31 | 126 |
| Total, other adverse events | Relugolix Plus Delayed E2/NETA (Group B) | 67 | 126 |
| Total, other adverse events | Placebo (Group C) | 42 | 129 |
| Total, serious adverse events | Relugolix Plus E2/NETA (Group A) | 1 | 126 |
| Total, serious adverse events | Relugolix Plus Delayed E2/NETA (Group B) | 2 | 126 |
| Total, serious adverse events | Placebo (Group C) | 4 | 129 |
Source ClinicalTrials.gov
Papers9
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Relugolix Plus E2/NETA (Group A) vs Placebo (Group C): Number Of Participants With Hemoglobin Increase Of ≥ 1 g/dL From Baseline To Week 24 Among Those With Below Lower Limit Of Normal | Trial comparisons |
| Relugolix Plus E2/NETA (Group A) vs Placebo (Group C): Sustained Amenorrhea Rate (No Or Negligible Bleeding) | Trial comparisons |
| Relugolix Plus E2/NETA (Group A) vs Placebo (Group C): Number Of Participants With A ≥ 30% Reduction in NRS Score From Baseline to Last 35 Days of Treatment Who Had Maximum Pain Scores ≥ 4 At Baseline | Trial comparisons |
| Relugolix Plus E2/NETA (Group A) vs Placebo (Group C): Number Of Responders With At Least 20 Points Decrease in UFS-QoL Bleeding And Pelvic Discomfort Scale Score | Trial comparisons |
Relugolix Plus E2/NETA (Group A) vs Placebo (Group C): Number Of Participants Who Achieved A Maximum NRS Score ≤ 1 For Uterine Fibroid-associated Pain Over The Last 35 Days Of Treatment Who Had Maximum Pain Scores ≥ 4 During The 35 Days Prior To Randomization | Trial comparisons |
| Relugolix Plus E2/NETA (Group A) vs Placebo (Group C): Number Of Participants With Hemoglobin ≤ 10.5 g/dL At Baseline And Achieved An Increase Of > 2 g/dL At Week 24 | Trial comparisons |
| Relugolix Plus E2/NETA (Group A) vs Placebo (Group C): Number Of Responders With At Least 20 Points Increase From Baseline At Week 24 In UFS-QoL Revised Activities Scale Score | Trial comparisons |
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/NCT03103087
GET https://conductscience.org/api/trials/v1/NCT03103087/registered?page=2