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NCT00698035 · OUTCOME

Change in Vaginal Epithelium Scores

Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients · Source last updated 2014-06-02

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

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, 12 weeks

What was measured

During a gynecologic exam, the vaginal epithelium was assessed by an examiner using the Vaginal Atrophy Scoring Scale to evaluate Rugae (lack of), Pallor (pinkness), Petechiae, Mucosal thinning, Dryness. Scores range from 0 (none) to 3 (severe); higher scores indicate less favorable outcomes.

Analysis population: Patients with both baseline and week 12 gynecologic exams for evaluation of vaginal atrophy

Groups in this outcome

Estring

Estring 2mg ring inserted vaginally once every 12 weeks

Testosterone Cream

Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment

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

Analysis denominator · Participants

GroupSource count
Estring35
Testosterone Cream34

Reported measurements

Rugae
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Estring-1.030.80Not reportedNot reportedNot reported
Testosterone Cream-0.710.84Not reportedNot reportedNot reported
Pallor
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Estring-0.880.84Not reportedNot reportedNot reported
Testosterone Cream-0.910.75Not reportedNot reportedNot reported
Petechiae
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Estring-1.01.07Not reportedNot reportedNot reported
Testosterone Cream-0.741.38Not reportedNot reportedNot reported
Mucosal thinning
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Estring-0.620.49Not reportedNot reportedNot reported
Testosterone Cream-0.880.64Not reportedNot reportedNot reported
Dryness
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Estring-1.030.80Not reportedNot reportedNot reported
Testosterone Cream-0.710.91Not reportedNot reportedNot reported

Source statistical analyses

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

  1. group Description
    Differences in rugae, pallor, petechiae, mucosal thinning and dryness between baseline and week 12
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    Significant at p\<0.05
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  2. group Description
    Differences in rugae, pallor, mucosal thinning, and dryness from baseline to 12 weeks
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    Significant at p\<0.05
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  3. group Description
    Difference in petechiae between baseline and week 12
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0061
    p Value Comment
    Significant at p\<0.05
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
Complete source fields
analyses
  1. group Description
    Differences in rugae, pallor, petechiae, mucosal thinning and dryness between baseline and week 12
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    Significant at p\<0.05
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  2. group Description
    Differences in rugae, pallor, mucosal thinning, and dryness from baseline to 12 weeks
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    Significant at p\<0.05
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  3. group Description
    Difference in petechiae between baseline and week 12
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0061
    p Value Comment
    Significant at p\<0.05
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.80
        value
        -1.03
      2. group Id
        OG001
        spread
        0.84
        value
        -0.71
    title
    Rugae
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.84
        value
        -0.88
      2. group Id
        OG001
        spread
        0.75
        value
        -0.91
    title
    Pallor
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.07
        value
        -1.0
      2. group Id
        OG001
        spread
        1.38
        value
        -0.74
    title
    Petechiae
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.49
        value
        -0.62
      2. group Id
        OG001
        spread
        0.64
        value
        -0.88
    title
    Mucosal thinning
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.80
        value
        -1.03
      2. group Id
        OG001
        spread
        0.91
        value
        -0.71
    title
    Dryness
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    2. group Id
      OG001
      value
      34
    units
    Participants
description
During a gynecologic exam, the vaginal epithelium was assessed by an examiner using the Vaginal Atrophy Scoring Scale to evaluate Rugae (lack of), Pallor (pinkness), Petechiae, Mucosal thinning, Dryness. Scores range from 0 (none) to 3 (severe); higher scores indicate less favorable outcomes.
dispersion Type
Standard Deviation
groups
  1. description
    Estring 2mg ring inserted vaginally once every 12 weeks
    id
    OG000
    title
    Estring
  2. description
    Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
    id
    OG001
    title
    Testosterone Cream
param Type
MEAN
population Description
Patients with both baseline and week 12 gynecologic exams for evaluation of vaginal atrophy
reporting Status
POSTED
time Frame
Baseline, 12 weeks
title
Change in Vaginal Epithelium Scores
type
SECONDARY
unit Of Measure
units on a scale

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Preserved source evidence · Not medical advice