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NCT01539317 · OUTCOME

Location of Pain in Postmenopausal Dyspareunia

Therapy to Prevent Sexual Pain in Breast Cancer Survivors · Source last updated 2017-04-14

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 from 0 to 10
Interval / dispersion
Inter-Quartile Range
Time frame
Enrollment visit

What was measured

To determine the specific site of vulvovaginal tenderness in menopausal breast cancer survivors who have entry dyspareunia. Examine the vulvar vestibule with a swab test to determine locations and severity of touch tenderness. Eight sites were evaluated around the vaginal opening and there location was in reference to a clock face. Measured using the Numerical Rating Scale, a scale which measures pain from 0 to 10 with 0="no pain" and 10="the worst pain you have ever felt".

Groups in this outcome

Topical Saline

Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule

Topical Liquid Lidocaine

Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule

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

Analysis denominator · Participants

GroupSource count
Topical Saline25
Topical Liquid Lidocaine24

Reported measurements

1 o'clock
Values in units on a scale from 0 to 10 · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Topical Saline0Not reported00Not reported
Topical Liquid Lidocaine0Not reported00Not reported
11 o'clock
Values in units on a scale from 0 to 10 · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Topical Saline0Not reported02Not reported
Topical Liquid Lidocaine0Not reported00Not reported
12 o'clock
Values in units on a scale from 0 to 10 · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Topical Saline1Not reported04Not reported
Topical Liquid Lidocaine0Not reported00Not reported
3 o'clock
Values in units on a scale from 0 to 10 · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Topical Saline3Not reported25Not reported
Topical Liquid Lidocaine0Not reported01Not reported
4 o'clock
Values in units on a scale from 0 to 10 · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Topical Saline4Not reported36Not reported
Topical Liquid Lidocaine0Not reported01Not reported
8 o'clock
Values in units on a scale from 0 to 10 · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Topical Saline4Not reported36Not reported
Topical Liquid Lidocaine0Not reported00.5Not reported
9 o'clock
Values in units on a scale from 0 to 10 · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Topical Saline5Not reported26Not reported
Topical Liquid Lidocaine0Not reported01Not reported
6 o'clock
Values in units on a scale from 0 to 10 · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Topical Saline2Not reported14Not reported
Topical Liquid Lidocaine0Not reported00Not reported

Source statistical analyses

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

  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    Each of 8 site comparisons had its own P-value and a value of \<0.001 was the difference at the most tender sites
    statistical Method
    Wilcoxon (Mann-Whitney)
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    p Value Comment
    Each of 8 site comparisons had its own P-value and a value of \<0.001 was the difference at the most tender sites
    statistical Method
    Wilcoxon (Mann-Whitney)
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        0
        value
        0
    title
    1 o'clock
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        2
        value
        0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        0
        value
        0
    title
    11 o'clock
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        4
        value
        1
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        0
        value
        0
    title
    12 o'clock
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2
        upper Limit
        5
        value
        3
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        1
        value
        0
    title
    3 o'clock
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3
        upper Limit
        6
        value
        4
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        1
        value
        0
    title
    4 o'clock
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3
        upper Limit
        6
        value
        4
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        0.5
        value
        0
    title
    8 o'clock
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2
        upper Limit
        6
        value
        5
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        1
        value
        0
    title
    9 o'clock
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        4
        value
        2
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        0
        value
        0
    title
    6 o'clock
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    2. group Id
      OG001
      value
      24
    units
    Participants
description
To determine the specific site of vulvovaginal tenderness in menopausal breast cancer survivors who have entry dyspareunia. Examine the vulvar vestibule with a swab test to determine locations and severity of touch tenderness. Eight sites were evaluated around the vaginal opening and there location was in reference to a clock face. Measured using the Numerical Rating Scale, a scale which measures pain from 0 to 10 with 0="no pain" and 10="the worst pain you have ever felt".
dispersion Type
Inter-Quartile Range
groups
  1. description
    Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
    id
    OG000
    title
    Topical Saline
  2. description
    Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
    id
    OG001
    title
    Topical Liquid Lidocaine
param Type
MEDIAN
reporting Status
POSTED
time Frame
Enrollment visit
title
Location of Pain in Postmenopausal Dyspareunia
type
PRIMARY
unit Of Measure
units on a scale from 0 to 10

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

Preserved source evidence · Not medical advice