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NCT01422408 · OUTCOME

Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics

Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy · Source last updated 2017-08-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
units on a scale
Interval / dispersion
Inter-Quartile Range
Time frame
Baseline and 4 weeks

What was measured

Association of response in symptoms with characteristics of the subject population (Dyspareunia and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.

Analysis population: The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.

Groups in this outcome

Supportive Care (Fluocinonide Cream)

This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Supportive Care (Fluocinonide Cream)34

Reported measurements

Anastrazole

Analysis denominator · Participants

GroupSource count
Supportive Care (Fluocinonide Cream)7
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Supportive Care (Fluocinonide Cream)-2Not reported-2.5-1.5Not reported
Exemestane

Analysis denominator · Participants

GroupSource count
Supportive Care (Fluocinonide Cream)3
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Supportive Care (Fluocinonide Cream)-2Not reported-2-2Not reported
Letrozole

Analysis denominator · Participants

GroupSource count
Supportive Care (Fluocinonide Cream)13
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Supportive Care (Fluocinonide Cream)-2.5Not reported-3-2Not reported
Tamoxifen

Analysis denominator · Participants

GroupSource count
Supportive Care (Fluocinonide Cream)11
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Supportive Care (Fluocinonide Cream)-1.5Not reported-1.75-1.25Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.8772
    p Value Comment
    No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
    statistical Comment
    Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
    statistical Method
    ANOVA
Complete source fields
analyses
  1. group Description
    In order to compare the response between groups, Kruskal-Wallis ANOVA was used.
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.8772
    p Value Comment
    No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons
    statistical Comment
    Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.
    statistical Method
    ANOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -2.5
        upper Limit
        -1.5
        value
        -2
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    Anastrazole
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -2
        upper Limit
        -2
        value
        -2
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Exemestane
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -3
        upper Limit
        -2
        value
        -2.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    Letrozole
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.75
        upper Limit
        -1.25
        value
        -1.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      units
      Participants
    title
    Tamoxifen
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    units
    Participants
description
Association of response in symptoms with characteristics of the subject population (Dyspareunia and current endocrine therapy) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.
dispersion Type
Inter-Quartile Range
groups
  1. description
    This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
    id
    OG000
    title
    Supportive Care (Fluocinonide Cream)
param Type
MEDIAN
population Description
The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.
reporting Status
POSTED
time Frame
Baseline and 4 weeks
title
Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics
type
SECONDARY
unit Of Measure
units on a scale

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Preserved source evidence · Not medical advice