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Trial · NCT03103087

Results by group102

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
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/NETARelugolix Plus E2/NETA (Group A)71.295% Confidence Interval 62.42 to 78.95Percentage 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/NETAPlacebo (Group C)14.7395% Confidence Interval 9.11 to 22.04Percentage of participants
Percentage Of Participants With Amenorrhea Over The Last 35 Days Of TreatmentRelugolix Plus E2/NETA (Group A)50.4095% Confidence Interval 41.32 to 59.46Percentage of participants
Percentage Of Participants With Amenorrhea Over The Last 35 Days Of TreatmentPlacebo (Group C)3.1095% Confidence Interval 0.85 to 7.75Percentage of participants
Percent Change From Baseline At Week 24 In MBL VolumeRelugolix Plus E2/NETA (Group A)-84.395% Confidence Interval -95.0 to -73.6percent change
Percent Change From Baseline At Week 24 In MBL VolumePlacebo (Group C)-15.195% Confidence Interval -25.8 to -4.3percent 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 24Relugolix Plus E2/NETA (Group A)61.2995% Confidence Interval 42.19 to 78.15Percentage 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 24Placebo (Group C)5.4195% Confidence Interval 0.66 to 18.19Percentage 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 TreatmentRelugolix Plus E2/NETA (Group A)47.0695% Confidence Interval 34.83 to 59.55percentage 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 TreatmentPlacebo (Group C)17.0795% Confidence Interval 9.66 to 26.98percentage of participants
Percent Change From Baseline At Week 24 In Primary Uterine Fibroid VolumeRelugolix Plus E2/NETA (Group A)-17.495% Confidence Interval -29.1 to -5.7percent change
Percent Change From Baseline At Week 24 In Primary Uterine Fibroid VolumePlacebo (Group C)-7.495% Confidence Interval -19.1 to 4.2percent change
Percent Change From Baseline At Week 24 In Uterine VolumeRelugolix Plus E2/NETA (Group A)-13.895% Confidence Interval -20.4 to -7.1percent change
Percent Change From Baseline At Week 24 In Uterine VolumePlacebo (Group C)-1.595% Confidence Interval -8.2 to 5.1percent change
Change From Baseline At Week 24 In UFS-QoL Bleeding And Pelvic Discomfort Scale Score As Measured By The UFS-QoL (Q1, Q2, Q5)Relugolix Plus E2/NETA (Group A)-51.795% Confidence Interval -57.4 to -46.0units on a scale
Change From Baseline At Week 24 In UFS-QoL Bleeding And Pelvic Discomfort Scale Score As Measured By The UFS-QoL (Q1, Q2, Q5)Placebo (Group C)-18.395% Confidence Interval -24.1 to -12.6units on a scale
Percent Change From Baseline At Week 12 In Bone Mineral Density At The Lumbar Spine (L1 to L4) As Assessed By DXARelugolix Plus E2/NETA (Group A)-0.819Standard Error 0.2686percent change
Percent Change From Baseline At Week 12 In Bone Mineral Density At The Lumbar Spine (L1 to L4) As Assessed By DXARelugolix Plus Delayed E2/NETA (Group B)-1.919Standard Error 0.2767percent change
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 DXARelugolix Plus E2/NETA (Group A)Lumbar Spine (L1-L4)-0.126Standard Error 0.2971percent change
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 DXAPlacebo (Group C)Lumbar Spine (L1-L4)0.315Standard Error 0.2909percent change

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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