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NCT00343382 · OUTCOME

Change From Baseline to Week 6 on the Impact of Vaginal Dryness for Activities of Daily Living Scores

Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer · Source last updated 2016-08-12

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 and Week 6

What was measured

The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The change from baseline scores was calculated by subtracting the baseline item scores from the scores at 6 week.

Analysis population: Includes all participants who completed both baseline and week 6 assessments.

Groups in this outcome

Collective Placebo

Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.

Pilocarpine 2 Times Per Day

Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.

Pilocarpine 4 Times Per Day

Patients receive 5mg of Pilocarpine 4 times per day for 6 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
Collective Placebo58
Pilocarpine 2 Times Per Day58
Pilocarpine 4 Times Per Day54

Reported measurements

Interfered with general activity
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Collective Placebo17.826.23Not reportedNot reportedNot reported
Pilocarpine 2 Times Per Day16.028.77Not reportedNot reportedNot reported
Pilocarpine 4 Times Per Day16.127.02Not reportedNot reportedNot reported
Interfered with mood
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Collective Placebo18.329.03Not reportedNot reportedNot reported
Pilocarpine 2 Times Per Day17.829.44Not reportedNot reportedNot reported
Pilocarpine 4 Times Per Day18.934.62Not reportedNot reportedNot reported
Interfered with normal work
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Collective Placebo11.023.15Not reportedNot reportedNot reported
Pilocarpine 2 Times Per Day6.018.16Not reportedNot reportedNot reported
Pilocarpine 4 Times Per Day9.122.17Not reportedNot reportedNot reported
Interfered with relations with other people
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Collective Placebo23.037.41Not reportedNot reportedNot reported
Pilocarpine 2 Times Per Day18.533.02Not reportedNot reportedNot reported
Pilocarpine 4 Times Per Day24.341.15Not reportedNot reportedNot reported
Interfered with sleep
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Collective Placebo5.619.27Not reportedNot reportedNot reported
Pilocarpine 2 Times Per Day5.112.75Not reportedNot reportedNot reported
Pilocarpine 4 Times Per Day10.821.99Not reportedNot reportedNot reported
Interfered with enjoyment of life
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Collective Placebo26.735.17Not reportedNot reportedNot reported
Pilocarpine 2 Times Per Day21.136.11Not reportedNot reportedNot reported
Pilocarpine 4 Times Per Day30.233.14Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.23
        value
        17.8
      2. group Id
        OG001
        spread
        28.77
        value
        16.0
      3. group Id
        OG002
        spread
        27.02
        value
        16.1
    title
    Interfered with general activity
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.03
        value
        18.3
      2. group Id
        OG001
        spread
        29.44
        value
        17.8
      3. group Id
        OG002
        spread
        34.62
        value
        18.9
    title
    Interfered with mood
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.15
        value
        11.0
      2. group Id
        OG001
        spread
        18.16
        value
        6.0
      3. group Id
        OG002
        spread
        22.17
        value
        9.1
    title
    Interfered with normal work
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        37.41
        value
        23.0
      2. group Id
        OG001
        spread
        33.02
        value
        18.5
      3. group Id
        OG002
        spread
        41.15
        value
        24.3
    title
    Interfered with relations with other people
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.27
        value
        5.6
      2. group Id
        OG001
        spread
        12.75
        value
        5.1
      3. group Id
        OG002
        spread
        21.99
        value
        10.8
    title
    Interfered with sleep
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        35.17
        value
        26.7
      2. group Id
        OG001
        spread
        36.11
        value
        21.1
      3. group Id
        OG002
        spread
        33.14
        value
        30.2
    title
    Interfered with enjoyment of life
denoms
  1. counts
    1. group Id
      OG000
      value
      58
    2. group Id
      OG001
      value
      58
    3. group Id
      OG002
      value
      54
    units
    Participants
description
The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The change from baseline scores was calculated by subtracting the baseline item scores from the scores at 6 week.
dispersion Type
Standard Deviation
groups
  1. description
    Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
    id
    OG000
    title
    Collective Placebo
  2. description
    Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
    id
    OG001
    title
    Pilocarpine 2 Times Per Day
  3. description
    Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
    id
    OG002
    title
    Pilocarpine 4 Times Per Day
param Type
MEAN
population Description
Includes all participants who completed both baseline and week 6 assessments.
reporting Status
POSTED
time Frame
Baseline and Week 6
title
Change From Baseline to Week 6 on the Impact of Vaginal Dryness for Activities of Daily Living Scores
type
SECONDARY
unit Of Measure
units on a scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice