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Comparison · NCT03018249-eded1985

Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA vs Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat: Percentage of Participants With a Histologic Response

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. Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA vs Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat: Percentage of Participants With a Histologic Response. Trial comparisons, record NCT03018249-eded1985. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03018249-eded1985

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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 10.7270.5180.868wilson
Risk in group 20.70.4810.855wilson
Risk difference, group 1 minus group 20.0273-0.2320.288newcombe hybrid score
Risk ratio, group 1 over group 21.040.7071.53log
Odds ratio, group 1 over group 21.140.2994.36log
Number needed to treat, for one more participant with the outcome on Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA than on Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat
36.7from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPAPatients receive medroxyprogesterone acetate IM on day 1 and undergo hysterectomy between days 21-24.1622OG000
Group 2Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and EntinostatMedroxyprogesterone acetate IM on day 1 and entinostat PO on days 1, 8, and 15. Followed by hysterectomy between days 21-24.1420OG001

Outcome

Type
SECONDARY
Title
Percentage of Participants With a Histologic Response
Description
Pre- and post-treatment slides for each patient were evaluated in pairs for complete or partial histologic response by one reviewer. Pre- and post-treatment slides for each patient were evaluated in pairs for complete or partial histologic response by one reviewer. A histologic response was defined as either the absence of identifiable adenocarcinoma in the hysterectomy specimen section (complete) or, subjectively, as the presence of a complex proliferation of glands that retain the architectural characteristics of adenocarcinoma, but with features of secretion, decreased nuclear stratification, or the presence of eosinophilic, squamous or mucinous metaplasia, when this was absent in the initial sample (partial).
Time frame
Specimens were collected at initial diagnostic biopsy and at hysterectomy on day 21-24 and analyzed in batch.
Population
Randomized, treated, evaluable pre and post treatment specimen available. There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. There was one participant with an inevaluable pre-treatment slide. There were two additional patients with insufficient tumor post-treatment and no slides were submitted; one in each reporting group. There was one additional patient with no specimens submitted in reporting group 2.

Source ClinicalTrials.gov

Trial

Title
Medroxyprogesterone Acetate With or Without Entinostat Before Surgery in Treating Patients With Endometrioid Endometrial Cancer
NCT number
NCT03018249
Phases
EARLY_PHASE1
Conditions
FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 3 Endometrial Endometrioid Adenocarcinoma
Interventions
Entinostat, Hysterectomy, Laboratory Biomarker Analysis, Medroxyprogesterone Acetate
Lead sponsor
National Cancer Institute (NCI)
Results first posted
2021-06-02

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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