Trial · NCT02655237
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Total PBAC Score of <10 From Week 6 to 12 | Week 6 to 12 | Full analysis set (FAS) included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Total PBAC Score of <10 From Week 2 to 6 | Week 2 to 6 | FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Total PBAC Score of <10 From Week 18 to 24 | Week 18 to 24 | FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Total PBAC Score of <10 for 6 Weeks Before the Final Dose of Study Drug | For 6 weeks before the final dose of study drug (up to Week 24) | FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Myoma Volumes at Weeks 2, 4, 8, 12 and 24 | Baseline, Weeks 2, 4, 8, 12 and 24 | FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point. | cm^3 | MEAN |
| SECONDARY | Percent Change From Baseline in Uterine Volumes at Weeks 2, 4, 8, 12 and 24 | Baseline, Weeks 2, 4, 8, 12 and 24 | FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point. | cm^3 | MEAN |
| SECONDARY | Change From Baseline in Hemoglobin at Weeks 4, 8, 12, 16, 20, 24 and Follow up | Baseline, Weeks 4, 8, 12, 16, 20, 24 and Follow up (up to Week 28) | FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point. | g/dL | MEAN |
| SECONDARY | Numerical Rating Scale (NRS) Score | From Week 6 to 12, from Week 2 to 6, from Week 18 to 24, and for 6 weeks before the final dose (up to Week 24) | FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Uterine Fibroid Symptom and Quality of Life (UFS-QOL)- Symptom Severity Score at Weeks 4, 8, 12, 16, 20, 24 and Follow-up | Baseline, Weeks 4, 8, 12, 16, 20, 24 and Follow-up (up to Week 28) | FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Uterine Fibroid Symptom and Quality of Life (UFS-QOL)- HRQL Total Scores at Weeks 4, 8, 12, 16, 20, 24 and Follow-up | Baseline, Weeks 4, 8, 12, 16, 20, 24 and Follow-up (up to Week 28) | FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point. | score on a scale | MEAN |
| SECONDARY | Number of Participants Who Had One or More Treatment Emergent Adverse Event (TEAE) | Up to Week 28 | Safety analysis set included all participants who received at least 1 dose of the study drug for the treatment period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Markedly Abnormal Values of Vital Signs | Up to Week 28 | Safety analysis set included all participants who received at least 1 dose of the study drug for the treatment period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TEAE Related to Weight | Up to Week 28 | Safety analysis set included all participants who received at least 1 dose of the study drug for the treatment period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TEAE Related to Standard 12-Lead ECGs | Up to Week 28 | Safety analysis set included all participants who received at least 1 dose of the study drug for the treatment period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Markedly Abnormal Values of Laboratory Test | Up to Week 28 | Safety analysis set included all participants who received at least 1 dose of the study drug for the treatment period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TEAE (Bone Density Decreased) Related to Bone Mineral Density | Up to Week 28 | Safety analysis set included all participants who received at least 1 dose of the study drug for the treatment period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TEAE Related to Biochemical Bone Metabolism Markers | Up to Week 28 | Safety analysis set included all participants who received at least 1 dose of the study drug for the treatment period. | 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/NCT02655237/outcomes