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NCT01422408 · OUTCOME

Change in Symptom Scores of Dyspareunia

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

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). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. 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 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

Source class 1
Values in units on a scale · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Supportive Care (Fluocinonide Cream)-2Not reported-3-1.8Not reported

Source statistical analyses

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

  1. group Description
    The primary endpoints (i.e., change in symptoms of vaginal dryness from the baseline to 4 weeks, and change in symptoms of dyspareunia from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.
    group Ids
    1. OG000
    non Inferiority Comment
    Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.
    non Inferiority Type
    OTHER
    p Value
    0.002
    p Value Comment
    2.5% significance level to account for two co-primary endpoints.
    statistical Method
    Wilcoxon (Mann-Whitney)
  2. ci Lower Limit
    0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.09
    group Description
    GEE (general estimating equations) methods were planned as a secondary analysis of the primary endpoints. Missing data for some of the weeks prevented these models from converging and we could not obtain valid results with these methods. Since this is a secondary analysis, we decided to compare symptom severity at baseline vs. week 4 (end of study). Symptoms are considered "severe" for scores 3 or 4 and "not severe" for scores 0, 1, 2
    group Ids
    1. OG000
    non Inferiority Comment
    Exact McNemar's test was used to test if the proportion of severe symptoms at baseline are equal to the proportion of severe symptoms at the end of the study.
    non Inferiority Type
    OTHER
    p Value
    0.062
    p Value Comment
    Since there are two-co-primary endpoints, the significance level is 2.5%
    param Type
    Odds Ratio (OR)
    param Value
    0
    statistical Method
    McNemar
Complete source fields
analyses
  1. group Description
    The primary endpoints (i.e., change in symptoms of vaginal dryness from the baseline to 4 weeks, and change in symptoms of dyspareunia from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.
    group Ids
    1. OG000
    non Inferiority Comment
    Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.
    non Inferiority Type
    OTHER
    p Value
    0.002
    p Value Comment
    2.5% significance level to account for two co-primary endpoints.
    statistical Method
    Wilcoxon (Mann-Whitney)
  2. ci Lower Limit
    0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.09
    group Description
    GEE (general estimating equations) methods were planned as a secondary analysis of the primary endpoints. Missing data for some of the weeks prevented these models from converging and we could not obtain valid results with these methods. Since this is a secondary analysis, we decided to compare symptom severity at baseline vs. week 4 (end of study). Symptoms are considered "severe" for scores 3 or 4 and "not severe" for scores 0, 1, 2
    group Ids
    1. OG000
    non Inferiority Comment
    Exact McNemar's test was used to test if the proportion of severe symptoms at baseline are equal to the proportion of severe symptoms at the end of the study.
    non Inferiority Type
    OTHER
    p Value
    0.062
    p Value Comment
    Since there are two-co-primary endpoints, the significance level is 2.5%
    param Type
    Odds Ratio (OR)
    param Value
    0
    statistical Method
    McNemar
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -3
        upper Limit
        -1.8
        value
        -2
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    units
    Participants
description
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). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. 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
reporting Status
POSTED
time Frame
Baseline and 4 weeks
title
Change in Symptom Scores of Dyspareunia
type
PRIMARY
unit Of Measure
units on a scale

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Preserved source evidence · Not medical advice