{"analyses":[{"groupDescription":"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.","groupIds":["OG000"],"nonInferiorityComment":"2.5% significance level to account for two co-primary endpoints.","nonInferiorityType":"OTHER","pValue":"0.002","statisticalMethod":"Wilcoxon (Mann-Whitney)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-6","upperLimit":"-3.8","value":"-5"}]}]}],"denoms":[{"counts":[{"groupId":"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.\n\nOutcome 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.\n\nAnalyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.","dispersionType":"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.\n\nAll 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)"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"Baseline and 4 weeks","title":"Change in Total Vaginal Index Score.","type":"SECONDARY","unitOfMeasure":"units on a scale"}