Trial · NCT03213457
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment | Month 6, Month 12 | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. Last observation carried forward. Per protocol, the primary comparison for the co-primary endpoints was between the elagolix plus E2/NETA and placebo arms only. | percentage of participants | NUMBER |
| PRIMARY | Co-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment | Month 6, Month 12 | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. Last observation carried forward. Per protocol, the primary comparison for the co-primary endpoints was between the elagolix plus E2/NETA and placebo arms only. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in DYS at Month 12 Based on Daily Assessment | Baseline, Month 12 | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in DYS at Month 6 Based on Daily Assessment | Baseline, Month 6 | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in DYS at Month 3 Based on Daily Assessment | Baseline, Month 3 | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Non-menstrual Pelvic Pain (NMPP) at Month 12 Based on Daily Assessment | Baseline, Month 12 | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in NMPP at Month 6 Based on Daily Assessment | Baseline, Month 6 | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in NMPP at Month 3 Based on Daily Assessment | Baseline, Month 3 | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Month 6 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score | Baseline, Month 6 | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Observed cases. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. | T-score | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Dyspareunia (DYSP) at Month 12 Based on Daily Assessment | Baseline, Month 12 | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in DYSP at Month 6 Based on Daily Assessment | Baseline, Month 6 | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in DYSP at Month 3 Based on Daily Assessment | Baseline, Month 3 | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Month 12 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score | Baseline, Month 12 | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Observed cases. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. | T-score | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Endometriosis-Associated Pain Score at Month 12 Assessed With Numeric Rating Scale (NRS) | Baseline, Month 12 | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Endometriosis-Associated Pain Score at Month 6 Assessed With NRS | Baseline, Month 6 | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Endometriosis-Associated Pain Score at Month 3 Assessed With NRS | Baseline, Month 3 | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. | score on a scale | LEAST_SQUARES_MEAN |
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/NCT03213457/outcomes