TriangleNCT01422408 · OUTCOME
Change in Total Vaginal Index Score.
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
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- Baseline and 4 weeks
What was measured
Change in total vaginal index score. The total vaginal index score is a numerical value ranging from zero to twelve, comprised of the three components of vaginal dryness, vaginal itching, and dyspareunia graded on an ordinal scale of zero to four added together. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -12 to +12; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.
Groups in this outcome
Supportive Care (Fluocinonide Cream)
This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
| Group | Source count |
|---|---|
| Supportive Care (Fluocinonide Cream) | 34 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Supportive Care (Fluocinonide Cream) | -5 | Not reported | -6 | -3.8 | Not reported |
Source statistical analyses
- group Description
- The secondary endpoints (i.e., change in symptoms of vaginal itching from the baseline to 4 weeks, and change in vaginal index score from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.
- group Ids
- OG000
- non Inferiority Comment
- 2.5% significance level to account for two co-primary endpoints.
- non Inferiority Type
- OTHER
- p Value
- 0.002
- statistical Method
- Wilcoxon (Mann-Whitney)
Complete source fields
- analyses
- group Description
- The secondary endpoints (i.e., change in symptoms of vaginal itching from the baseline to 4 weeks, and change in vaginal index score from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.
- group Ids
- OG000
- non Inferiority Comment
- 2.5% significance level to account for two co-primary endpoints.
- non Inferiority Type
- OTHER
- p Value
- 0.002
- statistical Method
- Wilcoxon (Mann-Whitney)
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -6
- upper Limit
- -3.8
- value
- -5
- denoms
- counts
- group Id
- OG000
- value
- 34
- units
- Participants
- description
- Change in total vaginal index score. The total vaginal index score is a numerical value ranging from zero to twelve, comprised of the three components of vaginal dryness, vaginal itching, and dyspareunia graded on an ordinal scale of zero to four added together. Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -12 to +12; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.
- dispersion Type
- Inter-Quartile Range
- groups
- description
- This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
- id
- OG000
- title
- Supportive Care (Fluocinonide Cream)
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Baseline and 4 weeks
- title
- Change in Total Vaginal Index Score.
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice