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Comparison · NCT03103087-05d109ef

Relugolix Plus E2/NETA (Group A) vs Placebo (Group C): Number Of Participants With Hemoglobin Increase Of ≥ 1 g/dL From Baseline To Week 24 Among Those With Below Lower Limit Of Normal

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 Participants With Hemoglobin Increase Of ≥ 1 g/dL From Baseline To Week 24 Among Those With Below Lower Limit Of Normal. Trial comparisons, record NCT03103087-05d109ef. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03103087-05d109ef

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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 10.5070.3920.622wilson
Risk in group 20.240.1580.348wilson
Risk difference, group 1 minus group 20.2670.1090.408newcombe hybrid score
Risk ratio, group 1 over group 22.111.333.36log
Odds ratio, group 1 over group 23.261.66.63log
Number needed to treat, for one more participant with the outcome on Relugolix Plus E2/NETA (Group A) than on Placebo (Group C)3.742.459.13from 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.3569OG000
Group 2Placebo (Group C)Placebo for relugolix co-administered with placebo for E2/NETA for 24 weeks1875OG001

Outcome

Type
SECONDARY
Title
Number Of Participants With Hemoglobin Increase Of ≥ 1 g/dL From Baseline To Week 24 Among Those With Below Lower Limit Of Normal
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
Week 24
Population
All randomized participants who received any amount of study drug and had analyzable data at the specified timeframe.

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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