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Trial · NCT03412890

Results by group201

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

OutcomeGroupCategoryValueSpreadUnits
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 TreatmentRelugolix Plus E2/NETA (Group A)86.5095% Confidence Interval 80.28 to 91.34percentage 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 TreatmentRelugolix Plus Delayed E2/NETA (Group B)79.8795% Confidence Interval 72.52 to 85.98percentage 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 TreatmentPlacebo (Group C)75.0095% Confidence Interval 67.65 to 81.42percentage of participants
Change From Pivotal Study Baseline In MBL Volume At Week 52Relugolix Plus E2/NETA (Group A)-251.6Standard Error 16.38mL
Change From Pivotal Study Baseline In MBL Volume At Week 52Relugolix Plus Delayed E2/NETA (Group B)-219.1Standard Error 13.91mL
Change From Pivotal Study Baseline In MBL Volume At Week 52Placebo (Group C)-204.7Standard Error 13.31mL
Percentage Of Participants Who Achieved Or Maintained Amenorrhea Over The Last 35 Days Of TreatmentRelugolix Plus E2/NETA (Group A)70.5595% Confidence Interval 62.92 to 77.42percentage of participants
Percentage Of Participants Who Achieved Or Maintained Amenorrhea Over The Last 35 Days Of TreatmentRelugolix Plus Delayed E2/NETA (Group B)68.4695% Confidence Interval 60.35 to 75.82percentage of participants
Percentage Of Participants Who Achieved Or Maintained Amenorrhea Over The Last 35 Days Of TreatmentPlacebo (Group C)57.9395% Confidence Interval 49.98 to 65.58percentage 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 52Relugolix Plus E2/NETA (Group A)58.9795% Confidence Interval 42.10 to 74.43percentage 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 52Relugolix Plus Delayed E2/NETA (Group B)78.9595% Confidence Interval 62.68 to 90.45percentage 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 52Placebo (Group C)42.1195% Confidence Interval 26.31 to 59.18percentage of participants
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 BaselineRelugolix Plus E2/NETA (Group A)56participants
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 BaselineRelugolix Plus Delayed E2/NETA (Group B)60participants
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 BaselinePlacebo (Group C)45participants
Change From Pivotal Study Baseline In Hemoglobin Concentration At Week 52Relugolix Plus E2/NETA (Group A)2.7Standard Error 0.24g/dL
Change From Pivotal Study Baseline In Hemoglobin Concentration At Week 52Relugolix Plus Delayed E2/NETA (Group B)3.0Standard Error 0.23g/dL
Change From Pivotal Study Baseline In Hemoglobin Concentration At Week 52Placebo (Group C)1.9Standard Error 0.22g/dL
Change From Pivotal Study Baseline In The UFS-QoL Symptom Severity Scale At Week 52Relugolix Plus E2/NETA (Group A)-37.3Standard Error 2.47score on a scale
Change From Pivotal Study Baseline In The UFS-QoL Symptom Severity Scale At Week 52Relugolix Plus Delayed E2/NETA (Group B)-38.2Standard Error 2.77score on a scale

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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