Comparison · NCT03103087-b4e65508
Relugolix Plus E2/NETA (Group A) vs Placebo (Group C): Number Of Participants Who Achieved A Maximum NRS Score ≤ 1 For Uterine Fibroid-associated Pain Over The Last 35 Days Of Treatment Who Had Maximum Pain Scores ≥ 4 During The 35 Days Prior To Randomization
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Relugolix Plus E2/NETA (Group A) vs Placebo (Group C): Number Of Participants Who Achieved A Maximum NRS Score ≤ 1 For Uterine Fibroid-associated Pain Over The Last 35 Days Of Treatment Who Had Maximum Pain Scores ≥ 4 During The 35 Days Prior To Randomization. Trial comparisons, record NCT03103087-b4e65508. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03103087-b4e65508
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.366 | 0.275 | 0.467 | wilson | |
| Risk in group 2 | 0.179 | 0.115 | 0.268 | wilson | |
| Risk difference, group 1 minus group 2 | 0.187 | 0.0595 | 0.307 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.04 | 1.23 | 3.39 | log | |
| Odds ratio, group 1 over group 2 | 2.64 | 1.35 | 5.18 | log | |
| Number needed to treat, for one more participant with the outcome on Relugolix Plus E2/NETA (Group A) than on Placebo (Group C) | 5.36 | 3.26 | 16.8 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Relugolix Plus E2/NETA (Group A) | Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks. | 34 | 93 | OG000 |
| Group 2 | Placebo (Group C) | Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks | 17 | 95 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
Number Of Participants Who Achieved A Maximum NRS Score ≤ 1 For Uterine Fibroid-associated Pain Over The Last 35 Days Of Treatment Who Had Maximum Pain Scores ≥ 4 During The 35 Days Prior To Randomization
- Description
Uterine fibroid-associated pain was assessed by a pain NRS. The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain).~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented.
- Time frame
- From Baseline up to the last 35 days of treatment (up to 24 weeks)
- Population
- All participants who were randomized to treatment and who received at least 1 dose of study drug who had a maximum NRS score ≥ 4 at baseline.
Source ClinicalTrials.gov
Trial
- Title
- LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
- NCT number
- NCT03103087
- Phases
- PHASE3
- Conditions
- Heavy Menstrual Bleeding, Uterine Fibroid
- Interventions
- Relugolix, Estradiol/norethindrone acetate, Relugolix placebo, Estradiol/norethindrone acetate placebo
- Lead sponsor
- Myovant Sciences GmbH
- Results first posted
- 2022-04-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03103087?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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