{"analyses":[{"groupDescription":"The primary endpoints (i.e., change in symptoms of vaginal dryness from the baseline to 4 weeks, and change in symptoms of dyspareunia from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary 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","pValueComment":"2.5% significance level to account for two co-primary endpoints.","statisticalMethod":"Wilcoxon (Mann-Whitney)"},{"ciLowerLimit":"0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.36","groupDescription":"GEE (general estimating equation) methods were planned as a secondary analysis of the primary endpoints. Missing data for some of the weeks prevented these models from converging and we could not obtain valid results with these methods. Since this is a secondary analysis, we decided to compare symptom severity at baseline vs. week 4 (end of study). Symptoms are considered \"severe\" for scores 3 or 4 and \"not severe\" for scores 0, 1, 2","groupIds":["OG000"],"nonInferiorityComment":"Exact McNemar's test was used to test if the proportion of severe symptoms at baseline are equal to the proportion of severe symptoms at the end of the study.","nonInferiorityType":"OTHER","pValue":"0.001","pValueComment":"Since there are two-co-primary endpoints, the significance level is 2.5%","paramType":"Odds Ratio (OR)","paramValue":"0","statisticalMethod":"McNemar"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3","upperLimit":"-1","value":"-2"}]}]}],"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-primary 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 Dryness","type":"PRIMARY","unitOfMeasure":"units on a scale"}