{"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":"Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.","nonInferiorityType":"OTHER","pValue":"0.001","statisticalMethod":"Wilcoxon (Mann-Whitney)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-2","upperLimit":"0","value":"-1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"}],"units":"Participants"}],"description":"Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.\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 -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.","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 Symptom Scores of Vaginal Itching","type":"SECONDARY","unitOfMeasure":"units on a scale"}