{"denoms":[{"counts":[{"groupId":"BG000","value":"34"}],"units":"Participants"}],"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":"BG000","title":"Supportive Care"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"29"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"5"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"9.39","value":"55.44"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"34"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"}],"title":"Pre-menopausal"},{"measurements":[{"groupId":"BG000","value":"33"}],"title":"Post-menopausal"}]}],"description":"Pre-menopausal versus post-menopausal (defined as either no menses ≥ 12 months, medical ovarian suppression with leuprolide or goserelin, bilateral ovarian ablation with radiation, or bilateral oophorectomy)\n\nThe subject's menopausal status will be classified according to the menopausal status at the time of enrollment on study.","paramType":"COUNT_OF_PARTICIPANTS","title":"Menopause status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7"}],"title":"Anastrazole"},{"measurements":[{"groupId":"BG000","value":"3"}],"title":"Exemestane"},{"measurements":[{"groupId":"BG000","value":"13"}],"title":"Letrozole"},{"measurements":[{"groupId":"BG000","value":"11"}],"title":"Tamoxifen"}]}],"description":"type of endocrine therapy currently taken by the subject\n\ntamoxifen vs. anastrazole vs. letrozole vs. exemestane","paramType":"COUNT_OF_PARTICIPANTS","title":"Current endocrine therapy","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"14"}],"title":"Prior cytotoxic chemotherapy"},{"measurements":[{"groupId":"BG000","value":"20"}],"title":"No prior cytotoxic chemotherapy"}]}],"description":"Whether the subject has received prior cytotoxic chemotherapy for breast cancer: prior cytotoxic chemotherapy versus no prior cytotoxic chemotherapy for breast cancer","paramType":"COUNT_OF_PARTICIPANTS","title":"Prior cytotoxic chemotherapy received","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"33"}],"title":"Adjuvant"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"Prophylaxis"}]}],"description":"use of endocrine therapy for preventative treatment with an increased risk for breast cancer vs. adjuvant treatment for a history of invasive breast cancer","paramType":"COUNT_OF_PARTICIPANTS","title":"Indications for endocrine therapy","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"15"}],"title":"Severe"},{"measurements":[{"groupId":"BG000","value":"19"}],"title":"Not severe"}]}],"description":"Severe symptoms indicated by a score of 3 or 4. Measured at study baseline","paramType":"COUNT_OF_PARTICIPANTS","title":"Severe baseline symptoms, Dryness","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"15"}],"title":"Severe"},{"measurements":[{"groupId":"BG000","value":"10"}],"title":"Not severe"},{"measurements":[{"groupId":"BG000","value":"9"}],"title":"Missing/not reported"}]}],"description":"Severe symptoms indicated by a score of 3 or 4. Measured at study baseline","paramType":"COUNT_OF_PARTICIPANTS","title":"Severe baseline symptoms, Dyspareunia","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"}],"title":"Severe"},{"measurements":[{"groupId":"BG000","value":"33"}],"title":"Not severe"}]}],"description":"Severe symptoms indicated by a score of 3 or 4. Measured at study baseline","paramType":"COUNT_OF_PARTICIPANTS","title":"Severe baseline symptoms, Itching","unitOfMeasure":"Participants"}],"populationDescription":"An intent-to-treat analysis set will include those who are enrolled in the trial regardless of the number of treatments received. All primary analyses will be conducted using the intent-to-treat analysis set. A safety analysis set will include those who receive at least one treatment."}