NCT01539317 · OUTCOME
Improvement of Quality of Sexual Life - Visit 3
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 3 (End of Study)
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 at Visit 1 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 | 17.79 | Not reported | 15 | 21 | Not reported |
|---|
| Topical Liquid Lidocaine | 18.32 | Not reported | 16 | 21 | Not reported |
|---|
Arousal Sensation
Values in Units on a scale · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Topical Saline | 10.89 | Not reported | 8 | 13 | Not reported |
|---|
| Topical Liquid Lidocaine | 13.15 | Not reported | 11 | 15.5 | Not reported |
|---|
Arousal Lubrication
Values in Units on a scale · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Topical Saline | 4.79 | Not reported | 4 | 6 | Not reported |
|---|
| Topical Liquid Lidocaine | 5.2 | Not reported | 4 | 6.5 | Not reported |
|---|
Arousal Cognitive
Values in Units on a scale · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Topical Saline | 5.74 | Not reported | 5 | 7 | Not reported |
|---|
| Topical Liquid Lidocaine | 7.05 | Not reported | 6 | 9 | Not reported |
|---|
Orgasm
Values in Units on a scale · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Topical Saline | 6.95 | Not reported | 1 | 11 | Not reported |
|---|
| Topical Liquid Lidocaine | 9.5 | Not reported | 7 | 13 | Not reported |
|---|
Pain
Values in Units on a scale · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Topical Saline | 11.18 | Not reported | 10.35 | 12 | Not reported |
|---|
| Topical Liquid Lidocaine | 11.67 | Not reported | 9.5 | 13.68 | Not reported |
|---|
Enjoyment
Values in Units on a scale · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Topical Saline | 20.90 | Not reported | 17.44 | 24.44 | Not reported |
|---|
| Topical Liquid Lidocaine | 22.51 | Not reported | 21.2 | 24 | Not reported |
|---|
Partner
Values in Units on a scale · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Topical Saline | 8.95 | Not reported | 8 | 10 | Not reported |
|---|
| Topical Liquid Lidocaine | 9.36 | Not reported | 9 | 10 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15
- upper Limit
- 21
- value
- 17.79
- group Id
- OG001
- lower Limit
- 16
- upper Limit
- 21
- value
- 18.32
- title
- Desire
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8
- upper Limit
- 13
- value
- 10.89
- group Id
- OG001
- lower Limit
- 11
- upper Limit
- 15.5
- value
- 13.15
- title
- Arousal Sensation
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4
- upper Limit
- 6
- value
- 4.79
- group Id
- OG001
- lower Limit
- 4
- upper Limit
- 6.5
- value
- 5.2
- title
- Arousal Lubrication
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5
- upper Limit
- 7
- value
- 5.74
- group Id
- OG001
- lower Limit
- 6
- upper Limit
- 9
- value
- 7.05
- title
- Arousal Cognitive
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- 11
- value
- 6.95
- group Id
- OG001
- lower Limit
- 7
- upper Limit
- 13
- value
- 9.5
- title
- Orgasm
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.35
- upper Limit
- 12
- value
- 11.18
- group Id
- OG001
- lower Limit
- 9.5
- upper Limit
- 13.68
- value
- 11.67
- title
- Pain
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.44
- upper Limit
- 24.44
- value
- 20.90
- group Id
- OG001
- lower Limit
- 21.2
- upper Limit
- 24
- value
- 22.51
- title
- Enjoyment
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8
- upper Limit
- 10
- value
- 8.95
- group Id
- OG001
- lower Limit
- 9
- upper Limit
- 10
- value
- 9.36
- title
- Partner
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 22
- units
- Participants
- description
- 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).
- 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 at Visit 1 scoring from the prior 30 days.
- reporting Status
- POSTED
- time Frame
- Visit 3 (End of Study)
- title
- Improvement of Quality of Sexual Life - Visit 3
- type
- SECONDARY
- unit Of Measure
- Units on a scale
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Preserved source evidence · Not medical advice
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