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Trial · NCT02993159

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change in Ki-67 Labeling IndexArm I (4-OHT Topical Gel, Placebo)-1.095% Confidence Interval -2.4 to 0.52percent positive cells
Change in Ki-67 Labeling IndexArm II (Placebo, Oral Tamoxifen)-4.895% Confidence Interval -6.6 to -3.1percent positive cells
Change in Oncotype DCIS-ScoreArm I (4-OHT Topical Gel, Placebo)-1.895% Confidence Interval -5.8 to 2.3score on a scale
Change in Oncotype DCIS-ScoreArm II (Placebo, Oral Tamoxifen)-1695% Confidence Interval -22 to -9.4score on a scale
Post-therapy Breast Tissue Levels of Tamoxifen and Its MetabolitesArm I (4-OHT Topical Gel, Placebo)4-OHT, Superficial tissue sample4.2Inter-Quartile Range 1.5 to 17.8ng/g
Post-therapy Breast Tissue Levels of Tamoxifen and Its MetabolitesArm II (Placebo, Oral Tamoxifen)4-OHT, Superficial tissue sample6.0Inter-Quartile Range 3.9 to 8.5ng/g
Post-therapy Breast Tissue Levels of Tamoxifen and Its MetabolitesArm I (4-OHT Topical Gel, Placebo)4-OHT, Deep tissue sample3.8Inter-Quartile Range 1.3 to 7.9ng/g
Post-therapy Breast Tissue Levels of Tamoxifen and Its MetabolitesArm II (Placebo, Oral Tamoxifen)4-OHT, Deep tissue sample5.7Inter-Quartile Range 4.0 to 7.9ng/g
Post-therapy Breast Tissue Levels of Tamoxifen and Its MetabolitesArm I (4-OHT Topical Gel, Placebo)Endoxifen, Superficial tissue sample0.2Inter-Quartile Range 0.2 to 0.3ng/g
Post-therapy Breast Tissue Levels of Tamoxifen and Its MetabolitesArm II (Placebo, Oral Tamoxifen)Endoxifen, Superficial tissue sample16Inter-Quartile Range 9.5 to 20.7ng/g
Post-therapy Breast Tissue Levels of Tamoxifen and Its MetabolitesArm I (4-OHT Topical Gel, Placebo)4-OHT, Deep tissue sample0.3Inter-Quartile Range 0.0 to 0.3ng/g
Post-therapy Breast Tissue Levels of Tamoxifen and Its MetabolitesArm II (Placebo, Oral Tamoxifen)4-OHT, Deep tissue sample13Inter-Quartile Range 8.9 to 20.6ng/g
Post-therapy Plasma Levels of Tamoxifen and Its MetabolitesArm I (4-OHT Topical Gel, Placebo)4-OHT, Plasma0.2Inter-Quartile Range 0.1 to 0.4ng/ml
Post-therapy Plasma Levels of Tamoxifen and Its MetabolitesArm II (Placebo, Oral Tamoxifen)4-OHT, Plasma2.0Inter-Quartile Range 1.4 to 2.7ng/ml
Post-therapy Plasma Levels of Tamoxifen and Its MetabolitesArm I (4-OHT Topical Gel, Placebo)Endoxifen, Plasma0.0Inter-Quartile Range 0.0 to 0.0ng/ml
Post-therapy Plasma Levels of Tamoxifen and Its MetabolitesArm II (Placebo, Oral Tamoxifen)Endoxifen, Plasma10.5Inter-Quartile Range 6.4 to 13.8ng/ml
Ki-67 Labelling Index in the Terminal Duct Lobular Units (TDLUs)Arm I (4-OHT Topical Gel, Placebo)-0.1195% Confidence Interval -1.20 to 0.98percent positive
Ki-67 Labelling Index in the Terminal Duct Lobular Units (TDLUs)Arm II (Placebo, Oral Tamoxifen)0.1695% Confidence Interval -0.67 to 0.99percent positive
Change in Plasma Proteins Involved in CoagulationArm I (4-OHT Topical Gel, Placebo)Factor VIII-0.5095% Confidence Interval -12 to 11percent
Change in Plasma Proteins Involved in CoagulationArm II (Placebo, Oral Tamoxifen)Factor VIII-8.895% Confidence Interval -19 to 1.5percent

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
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
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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