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Comparison · NCT03103087-dd5c8232

Relugolix Plus E2/NETA (Group A) vs Placebo (Group C): Number Of Responders With At Least 20 Points Increase From Baseline At Week 24 In UFS-QoL Revised Activities Scale Score

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Relugolix Plus E2/NETA (Group A) vs Placebo (Group C): Number Of Responders With At Least 20 Points Increase From Baseline At Week 24 In UFS-QoL Revised Activities Scale Score. Trial comparisons, record NCT03103087-dd5c8232. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03103087-dd5c8232

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.6240.5370.704wilson
Risk in group 20.3260.2510.41wilson
Risk difference, group 1 minus group 20.2980.1770.408newcombe hybrid score
Risk ratio, group 1 over group 21.921.442.54log
Odds ratio, group 1 over group 23.442.055.76log
Number needed to treat, for one more participant with the outcome on Relugolix Plus E2/NETA (Group A) than on Placebo (Group C)3.352.455.66from the risk difference interval

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Relugolix Plus E2/NETA (Group A)Relugolix 40 mg co-administered with E2 (1.0 mg) and NETA (0.5 mg) for 24 weeks.78125OG000
Group 2Placebo (Group C)Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks42129OG001

Outcome

Type
SECONDARY
Title
Number Of Responders With At Least 20 Points Increase From Baseline At Week 24 In UFS-QoL Revised Activities Scale Score
Description
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 through Week 24
Population
All participants who were randomized to treatment and who received at least 1 dose of study drug.

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

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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