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NCT00698035 · OUTCOME

Sexual Quality of Life

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, Week 4, Week 12

What was measured

Cancer Rehabilitation Evaluation System (CARES) Sexual Dysfunction (SD) and Sexual Interest (SI) Subscales range from 0 to 4 and measure the severity of problems, with higher scores indicating more difficulty.

Analysis population: Participants who provided responses to SD, SI and SS at 3 time points: Baseline (BL), Week 4 (W4), and Week 12 (W12)

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
Estring32
Testosterone Cream30

Reported measurements

SI (BL)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Estring1.20.9Not reportedNot reportedNot reported
Testosterone Cream1.40.8Not reportedNot reportedNot reported
SI (W4)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Estring1.31.0Not reportedNot reportedNot reported
Testosterone Cream1.20.7Not reportedNot reportedNot reported
SI (W12)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Estring0.90.7Not reportedNot reportedNot reported
Testosterone Cream1.00.6Not reportedNot reportedNot reported
SD (BL)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Estring2.91.1Not reportedNot reportedNot reported
Testosterone Cream2.90.8Not reportedNot reportedNot reported
SD (W4)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Estring2.41.1Not reportedNot reportedNot reported
Testosterone Cream2.11.0Not reportedNot reportedNot reported
SD (W12)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Estring2.01.1Not reportedNot reportedNot reported
Testosterone Cream1.91.1Not reportedNot reportedNot reported

Source statistical analyses

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

  1. group Description
    Change in SI from BL to W12
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.021
    p Value Comment
    Significant at p\<0.05
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  2. group Description
    Change in SD from BL to W12
    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
  3. group Description
    Change in SI from BL to W12
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0228
    p Value Comment
    Significant at p\<0.05
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  4. group Description
    Change in SD from BL to W12
    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
Complete source fields
analyses
  1. group Description
    Change in SI from BL to W12
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.021
    p Value Comment
    Significant at p\<0.05
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  2. group Description
    Change in SD from BL to W12
    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
  3. group Description
    Change in SI from BL to W12
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0228
    p Value Comment
    Significant at p\<0.05
    statistical Method
    t-test, 2 sided
    tested Non Inferiority
    false
  4. group Description
    Change in SD from BL to W12
    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
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.9
        value
        1.2
      2. group Id
        OG001
        spread
        0.8
        value
        1.4
    title
    SI (BL)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.0
        value
        1.3
      2. group Id
        OG001
        spread
        0.7
        value
        1.2
    title
    SI (W4)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.7
        value
        0.9
      2. group Id
        OG001
        spread
        0.6
        value
        1.0
    title
    SI (W12)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.1
        value
        2.9
      2. group Id
        OG001
        spread
        0.8
        value
        2.9
    title
    SD (BL)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.1
        value
        2.4
      2. group Id
        OG001
        spread
        1.0
        value
        2.1
    title
    SD (W4)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.1
        value
        2.0
      2. group Id
        OG001
        spread
        1.1
        value
        1.9
    title
    SD (W12)
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    2. group Id
      OG001
      value
      30
    units
    Participants
description
Cancer Rehabilitation Evaluation System (CARES) Sexual Dysfunction (SD) and Sexual Interest (SI) Subscales range from 0 to 4 and measure the severity of problems, with higher scores indicating more difficulty.
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
Participants who provided responses to SD, SI and SS at 3 time points: Baseline (BL), Week 4 (W4), and Week 12 (W12)
reporting Status
POSTED
time Frame
Baseline, Week 4, Week 12
title
Sexual Quality of Life
type
SECONDARY
unit Of Measure
units on a scale

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Preserved source evidence · Not medical advice