Trial · NCT03412890
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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 |
| SECONDARY | Change From Pivotal Study Baseline In Uterine 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. | cm^3 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Pivotal Study Baseline In Uterine Fibroid 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. | cm^3 | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Pivotal Study Baseline In Bone Mineral Density (BMD) At The Lumbar Spine (L1-L4), Femoral Neck, And Total Hip At Week 52 | Week 52 | Extension Safety Population: all enrolled participants who received any amount of open-label study drug in the open-label extension study. The overall number of participants analyzed is then umber of patients at baseline. The number analyzed at each location is the number of patients included in summary statistics for that location and timepoint. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Pivotal Study Baseline In Predose Serum E2 Concentrations At Week 52 | Week 52 | Extension Safety Population: all enrolled participants who received any amount of open-label study drug in the open-label extension study. | pg/mL | MEAN |
| OTHER_PRE_SPECIFIED | Change From Pivotal Study Baseline In European Quality Of Life Five Dimension Five Level (EQ-5D-5L) 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. | 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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GET https://conductscience.org/api/trials/v1/NCT03412890/outcomes