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Comparison · NCT02122198-deaths

GnRH Agonist vs Placebo: deaths from any cause

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. GnRH Agonist vs Placebo: deaths from any cause. Trial comparisons, record NCT02122198-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02122198-deaths

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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 100.00000000000000002780.242wilson
Risk in group 2000.434wilson
Risk difference, group 1 minus group 20-0.4340.242newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1GnRH Agonist
Monthly injections of leuprolide acetate 3.75mg for 9 months; first 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study protocol.~Weekly application of estradiol patch 0.075mg/d months 6-9.~Daily medroxyprogesterone acetate 5mg by mouth for 12 days at week 30.~Leuprolide acetate: Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study.~Estradiol: Climara transdermal patch 0.075mg/day applied weekly months 6-9~Medroxyprogesterone: Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.
012EG001
Group 2PlaceboMonthly placebo injections for 6 months under parent study (FAME) protocol (NCT01712230)~Placebo: placebo05EG000

Harm

What it counts
Total, all-cause mortality
Time frame
9 months

Source ClinicalTrials.gov

Trial

Title
Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women
NCT number
NCT02122198
Phases
NA
Conditions
Cognitive Impairment, Executive Dysfunction, Endothelial Dysfunction, Cardiovascular Disease
Interventions
Leuprolide acetate, Estradiol, Medroxyprogesterone, Placebo
Lead sponsor
University of Colorado, Denver
Results first posted
2022-01-10

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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