Trial · NCT03103087
Outcomes44
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 44
Download this page as JSON| 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 |
| SECONDARY | Percentage Of Participants Experiencing Vasomotor Symptoms Through Week 12 | Baseline through 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. | percentage of participants | NUMBER |
| SECONDARY | Percentage Of Participants Experiencing Vasomotor Symptoms Through Week 24 | 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. | percentage of participants | NUMBER |
| SECONDARY | Predose Trough Concentrations Of Relugolix And NET In The Relugolix Plus E2/NETA Group At Week 24 | 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. | ng/mL | MEAN |
| SECONDARY | Predose Trough Concentrations Of E2 In The Relugolix Plus E2/NETA Group At Week 24 | 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. | pg/mL | MEAN |
| SECONDARY | Change From Baseline At Week 24 In Predose Concentrations Of E2 In The Relugolix Plus E2/NETA Group | Baseline, 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. | pg/mL | MEAN |
| SECONDARY | Time To MBL Response | From Baseline through Week 24 | All participants who were randomized to treatment and who received at least 1 dose of study drug. | weeks | MEDIAN |
| SECONDARY | Sustained Amenorrhea Rate (No Or Negligible Bleeding) | Week 24 | All participants who were randomized to treatment and who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time To Achieving Sustained Amenorrhea (No Or Negligible Bleeding) | From Baseline through Week 24 | All participants who were randomized to treatment and who received at least 1 dose of study drug. | weeks | MEDIAN |
| SECONDARY | Time To Achieving Amenorrhea (No Or Negligible Bleeding) | From Baseline through Week 24 | All participants who were randomized to treatment and who received at least 1 dose of study drug and had analyzable data at the specified timepoint. | weeks | MEDIAN |
| SECONDARY | Number Of Participants With Hemoglobin ≤ 10.5 g/dL At Baseline And Achieved An Increase Of > 2 g/dL At Week 24 | From Baseline through Week 24 | All participants who were randomized to treatment, received at least 1 dose of study drug, and had hemoglobin ≤ 10.5 g/dL at Baseline and an assessment at Week 24. | Participants | COUNT_OF_PARTICIPANTS |
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.
For software
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