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NCT01422408 · OUTCOME

Change in Dyspareunia Symptom Scores by Patient Reported Compliance 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 patient reported compliance (Dyspareunia) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. 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. Groups are made by % of compliance reported by patients

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

50 - 74%

Analysis denominator · Participants

GroupSource count
Supportive Care (Fluocinonide Cream)1
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Supportive Care (Fluocinonide Cream)NANot reportedNANAData is missing; could not calculate
>= 75%

Analysis denominator · Participants

GroupSource count
Supportive Care (Fluocinonide Cream)29
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Supportive Care (Fluocinonide Cream)-2Not reported-3-1.75Not reported
Missing / not reported

Analysis denominator · Participants

GroupSource count
Supportive Care (Fluocinonide Cream)4
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Supportive Care (Fluocinonide Cream)NANot reportedNANAData is missing; could not calculate

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
    0.3676
    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
    0.3676
    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. comment
        Data is missing; could not calculate
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    50 - 74%
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -3
        upper Limit
        -1.75
        value
        -2
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      units
      Participants
    title
    >= 75%
  3. categories
    1. measurements
      1. comment
        Data is missing; could not calculate
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Missing / not reported
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    units
    Participants
description
Association of response in symptoms with patient reported compliance (Dyspareunia) Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance. 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. Groups are made by % of compliance reported by patients
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 Patient Reported Compliance Characteristics
type
SECONDARY
unit Of Measure
units on a scale

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Preserved source evidence · Not medical advice