TriangleNCT01539317 · OUTCOME
Prevention of Entry Dyspareunia With Non-hormonal Therapy
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
- During Phase II (0-4 weeks) and during Phase III (5-12 weeks)
What was measured
Mean intercourse pain reported by subjects using the Numerical Rating Scale pain ratings (range 0-10, 0 being "no pain" and 10 being "worst possible pain"). Testing was during weeks 0-4 (Phase II) (with blinded randomization for placebo vs active intervention medication) and testing was during weeks 5-12 (Phase III) (with open-label active medication for 8 weeks after completing the blinded 4 weeks). Subjects agreed to try penetration twice per week and score their pain using the Numerical Rating Scale pain ratings.The scores were averaged during each phase.
Groups in this outcome
Topical Saline
Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness
Topical Liquid Lidocaine
Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness
Open Label
During Open-label Lidocaine 8 weeks Each prior arm converted to use of open label lidocaine for 2 further months.
| Group | Source count |
|---|---|
| Topical Saline | 21 |
| Topical Liquid Lidocaine | 22 |
| Open Label | 41 |
Reported measurements
Phase II
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Topical Saline | 5.3 | Not reported | 3 | 7 | Not reported |
| Topical Liquid Lidocaine | 1.04 | Not reported | 0.65 | 1.92 | Not reported |
| Open Label | NA | Not reported | NA | NA | Phase II was not the open label portion of the study |
Phase III
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Topical Saline | 0.57 | Not reported | 0.07 | 1.80 | Not reported |
| Topical Liquid Lidocaine | 0.45 | Not reported | 0 | 1.14 | Not reported |
| Open Label | 0.48 | Not reported | 0 | 1.78 | Not reported |
Source statistical analyses
- group Description
- Phase II: During Blinded 4 weeks
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0149
- statistical Method
- Wilcoxon (Mann-Whitney)
- group Description
- Phase III
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.412
- statistical Method
- Wilcoxon (Mann-Whitney)
Complete source fields
- analyses
- group Description
- Phase II: During Blinded 4 weeks
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0149
- statistical Method
- Wilcoxon (Mann-Whitney)
- group Description
- Phase III
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.412
- statistical Method
- Wilcoxon (Mann-Whitney)
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3
- upper Limit
- 7
- value
- 5.3
- group Id
- OG001
- lower Limit
- 0.65
- upper Limit
- 1.92
- value
- 1.04
- comment
- Phase II was not the open label portion of the study
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- title
- Phase II
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.07
- upper Limit
- 1.80
- value
- 0.57
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 1.14
- value
- 0.45
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 1.78
- value
- 0.48
- title
- Phase III
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 41
- units
- Participants
- description
- Mean intercourse pain reported by subjects using the Numerical Rating Scale pain ratings (range 0-10, 0 being "no pain" and 10 being "worst possible pain"). Testing was during weeks 0-4 (Phase II) (with blinded randomization for placebo vs active intervention medication) and testing was during weeks 5-12 (Phase III) (with open-label active medication for 8 weeks after completing the blinded 4 weeks). Subjects agreed to try penetration twice per week and score their pain using the Numerical Rating Scale pain ratings.The scores were averaged during each phase.
- dispersion Type
- Inter-Quartile Range
- groups
- description
- Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness
- id
- OG000
- title
- Topical Saline
- description
- Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness
- id
- OG001
- title
- Topical Liquid Lidocaine
- description
- During Open-label Lidocaine 8 weeks Each prior arm converted to use of open label lidocaine for 2 further months.
- id
- OG002
- title
- Open Label
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- During Phase II (0-4 weeks) and during Phase III (5-12 weeks)
- title
- Prevention of Entry Dyspareunia With Non-hormonal Therapy
- type
- PRIMARY
- unit Of Measure
- Units on a scale
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Preserved source evidence · Not medical advice