NCT01539317 · OUTCOME

Improvement of Quality of Sexual Life - Visit 1

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: MEAN
Unit: units on a scale
Interval / dispersion: Inter-Quartile Range
Time frame: Visit 1 (Enrollment)

What was measured

To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by average scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function).

Analysis population: Averaged scores of Sexual Function Questionnaire Visit 1 each time scoring from the prior 30 days.

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

Group	Source count
Topical Saline	21
Topical Liquid Lidocaine	22

Reported measurements

Desire

Values in units on a scale · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
Topical Saline	11.91	Not reported	9	14	Not reported
Topical Liquid Lidocaine	13.87	Not reported	12	16	Not reported

Arousal Sensation

Values in units on a scale · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
Topical Saline	8.44	Not reported	6	11	Not reported
Topical Liquid Lidocaine	9.15	Not reported	8	10	Not reported

Arousal Lubrication

Values in units on a scale · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
Topical Saline	3.92	Not reported	2	4	Not reported
Topical Liquid Lidocaine	2.97	Not reported	2	4	Not reported

Arousal Cognitive

Values in units on a scale · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
Topical Saline	4.28	Not reported	4	5	Not reported
Topical Liquid Lidocaine	4.82	Not reported	4	6	Not reported

Orgasm

Values in units on a scale · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
Topical Saline	5.70	Not reported	1	10	Not reported
Topical Liquid Lidocaine	7.62	Not reported	1	13	Not reported

Pain

Values in units on a scale · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
Topical Saline	6.04	Not reported	4.48	8	Not reported
Topical Liquid Lidocaine	6.29	Not reported	5	8.48	Not reported

Enjoyment

Values in units on a scale · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
Topical Saline	15.30	Not reported	12	17.68	Not reported
Topical Liquid Lidocaine	17.01	Not reported	14	18.97	Not reported

Partner

Values in units on a scale · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
Topical Saline	7.78	Not reported	6	9	Not reported
Topical Liquid Lidocaine	8.13	Not reported	7	10	Not reported

Source statistical analyses

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

group Description
Desire
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.66
statistical Method
Wilcoxon (Mann-Whitney)
group Description
Arousal (S)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.11
statistical Method
Wilcoxon (Mann-Whitney)
group Description
Arousal (L)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.15
statistical Method
Wilcoxon (Mann-Whitney)
group Description
Arousal (C)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.28
statistical Method
Wilcoxon (Mann-Whitney)
group Description
Orgasm
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.07
statistical Method
Wilcoxon (Mann-Whitney)
group Description
Pain
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.004
statistical Method
Wilcoxon (Mann-Whitney)
group Description
Enjoyment
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.54
statistical Method
Wilcoxon (Mann-Whitney)
group Description
Partner
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.92
statistical Method
Wilcoxon (Mann-Whitney)

Complete source fields

analyses

group Description
Desire
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.66
statistical Method
Wilcoxon (Mann-Whitney)
group Description
Arousal (S)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.11
statistical Method
Wilcoxon (Mann-Whitney)
group Description
Arousal (L)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.15
statistical Method
Wilcoxon (Mann-Whitney)
group Description
Arousal (C)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.28
statistical Method
Wilcoxon (Mann-Whitney)
group Description
Orgasm
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.07
statistical Method
Wilcoxon (Mann-Whitney)
group Description
Pain
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.004
statistical Method
Wilcoxon (Mann-Whitney)
group Description
Enjoyment
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.54
statistical Method
Wilcoxon (Mann-Whitney)
group Description
Partner
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.92
statistical Method
Wilcoxon (Mann-Whitney)

classes

categories
measurements
group Id
OG000
lower Limit
9
upper Limit
14
value
11.91
group Id
OG001
lower Limit
12
upper Limit
16
value
13.87
title
Desire
categories
measurements
group Id
OG000
lower Limit
6
upper Limit
11
value
8.44
group Id
OG001
lower Limit
8
upper Limit
10
value
9.15
title
Arousal Sensation
categories
measurements
group Id
OG000
lower Limit
2
upper Limit
4
value
3.92
group Id
OG001
lower Limit
2
upper Limit
4
value
2.97
title
Arousal Lubrication
categories
measurements
group Id
OG000
lower Limit
4
upper Limit
5
value
4.28
group Id
OG001
lower Limit
4
upper Limit
6
value
4.82
title
Arousal Cognitive
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
10
value
5.70
group Id
OG001
lower Limit
1
upper Limit
13
value
7.62
title
Orgasm
categories
measurements
group Id
OG000
lower Limit
4.48
upper Limit
8
value
6.04
group Id
OG001
lower Limit
5
upper Limit
8.48
value
6.29
title
Pain
categories
measurements
group Id
OG000
lower Limit
12
upper Limit
17.68
value
15.30
group Id
OG001
lower Limit
14
upper Limit
18.97
value
17.01
title
Enjoyment
categories
measurements
group Id
OG000
lower Limit
6
upper Limit
9
value
7.78
group Id
OG001
lower Limit
7
upper Limit
10
value
8.13
title
Partner

denoms

counts
group Id
OG000
value
21
group Id
OG001
value
22
units
Participants

description

dispersion Type

Inter-Quartile Range

groups

description
Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
id
OG000
title
Topical Saline
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

MEAN

population Description

Averaged scores of Sexual Function Questionnaire Visit 1 each time scoring from the prior 30 days.

reporting Status

POSTED

time Frame

Visit 1 (Enrollment)

title

Improvement of Quality of Sexual Life - Visit 1

type

SECONDARY

unit Of Measure

units on a scale

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Preserved source evidence · Not medical advice