Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 9:50 PM
Study NCT ID:
NCT01422408
Status:
COMPLETED
Last Update Posted:
2017-08-09
First Post:
2011-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005447', 'term': 'Fluocinonide'}], 'ancestors': [{'id': 'D005446', 'term': 'Fluocinolone Acetonide'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'latour@ohsu.edu', 'phone': '503-418-9601', 'title': 'Emile Latour', 'organization': 'Knight Cancer Institute, Oregon Health & Science University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': "Original plan was to use GEE modeling for secondary analysis of primary endpoints. Missing data and small counts caused us to perform this analysis using other statistical methods. Data was categorized and tested using McNemar's Test for results"}}, 'adverseEventsModule': {'timeFrame': 'End of study week 1, 2, 3, 4', 'description': 'Toxicities and adverse events will be assessed using the NCI Common Toxicity Criteria (CTC) Version 4.0. Since CTEP has standardized the CTC, the NCI does not require the inclusion of the CTC within the protocol document. A copy can be downloaded from the CTEP home page (http://ctep.info.nih.gov).', 'eventGroups': [{'id': 'EG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 24, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bullous dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE Version 4.'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE Version 4.'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE Version 4.'}, {'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE Version 4.'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE Version 4.'}, {'term': 'Rash acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE Version 4.'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE Version 4.'}, {'term': 'Vaginal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE Version 4.'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Symptom Scores of Vaginal Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': '2.5% significance level to account for two co-primary endpoints.', '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.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.'}, {'pValue': '0.001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '0.36', 'pValueComment': 'Since there are two-co-primary endpoints, the significance level is 2.5%', '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', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'OTHER', '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."}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Symptom Scores of Dyspareunia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-1.8'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'pValueComment': '2.5% significance level to account for two co-primary endpoints.', '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.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.'}, {'pValue': '0.062', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '1.09', 'pValueComment': 'Since there are two-co-primary endpoints, the significance level is 2.5%', 'groupDescription': 'GEE (general estimating equations) 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', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'OTHER', '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."}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Symptom Scores of Vaginal Itching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], '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.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Total Vaginal Index Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5', 'groupId': 'OG000', 'lowerLimit': '-6', 'upperLimit': '-3.8'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], '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.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '2.5% significance level to account for two co-primary endpoints.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Experiencing Toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Over 4 weeks', 'description': 'Toxicity data will be reported as descriptive data as the percentage of patients experiencing reported side effects. Toxicity and safety analyses will be conducted using the safety analysis set.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Toxicity and safety analyses will be conducted using the safety analysis set.'}, {'type': 'SECONDARY', 'title': 'Change in Vaginal Dryness Symptom Scores by Age Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'title': 'Age 18-45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '-1.0'}]}]}, {'title': 'Age 46-55', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '-2.0'}]}]}, {'title': 'Age 56-65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '-1.5'}]}]}, {'title': 'Age > 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '-0.75'}]}]}], 'analyses': [{'pValue': '0.1029', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons', 'groupDescription': 'In order to compare the response between groups, Kruskal-Wallis ANOVA was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Dryness and Age)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.'}, {'type': 'SECONDARY', 'title': 'Change in Dyspareunia Symptom Scores by Age Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'title': 'Age 18-45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '-1'}]}]}, {'title': 'Age 46-55', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '-2'}]}]}, {'title': 'Age 56-65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-1.75'}]}]}, {'title': 'Age > 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-3'}]}]}], 'analyses': [{'pValue': '0.2678', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons', 'groupDescription': 'In order to compare the response between groups, Kruskal-Wallis ANOVA was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Dyspareunia and Age)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.'}, {'type': 'SECONDARY', 'title': 'Change in Vaginal Itching Symptom Scores by Age Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'title': 'Age 18-45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-1.25', 'upperLimit': '0.25'}]}]}, {'title': 'Age 46-55', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '0'}]}]}, {'title': 'Age 56-65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-1.75', 'upperLimit': '0'}]}]}, {'title': 'Age > 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-1.25', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '0.2472', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons', 'groupDescription': 'In order to compare the response between groups, Kruskal-Wallis ANOVA was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Itching and Age)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.'}, {'type': 'SECONDARY', 'title': 'Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'title': 'Pre-Menopause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '-2'}]}]}, {'title': 'Post-menopause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-1'}]}]}], 'analyses': [{'pValue': '0.507', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons', 'groupDescription': 'In order to compare the response between groups, Kruskal-Wallis ANOVA was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Dryness and Menopause status)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.'}, {'type': 'SECONDARY', 'title': 'Change in Dyspareunia Symptom Scores by Menopause Status Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'title': 'Pre-Menopause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Missing data for the one subject in this group.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Post-menopause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-1.75'}]}]}], 'analyses': [{'pValue': '0.3676', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons', 'groupDescription': 'In order to compare the response between groups, Kruskal-Wallis ANOVA was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Dyspareunia and Menopause status)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.'}, {'type': 'SECONDARY', 'title': 'Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'title': 'Pre-Menopause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '-1'}]}]}, {'title': 'Post-menopause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '0.6023', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons', 'groupDescription': 'In order to compare the response between groups, Kruskal-Wallis ANOVA was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Itching and Menopause status)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.'}, {'type': 'SECONDARY', 'title': 'Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'title': 'Anastrazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-2.75', 'upperLimit': '-2.0'}]}]}, {'title': 'Exemestane', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '-1.5'}]}]}, {'title': 'Letrozole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-1'}]}]}, {'title': 'Tamoxifen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '-1.25'}]}]}], 'analyses': [{'pValue': '0.6587', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons', 'groupDescription': 'In order to compare the response between groups, Kruskal-Wallis ANOVA was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Dryness and current endocrine therapy)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.'}, {'type': 'SECONDARY', 'title': 'Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'title': 'Anastrazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '-1.5'}]}]}, {'title': 'Exemestane', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '-2'}]}]}, {'title': 'Letrozole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-2'}]}]}, {'title': 'Tamoxifen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-1.75', 'upperLimit': '-1.25'}]}]}], 'analyses': [{'pValue': '0.8772', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons', 'groupDescription': 'In order to compare the response between groups, Kruskal-Wallis ANOVA was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Dyspareunia and current endocrine therapy)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.'}, {'type': 'SECONDARY', 'title': 'Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'title': 'Anastrazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '0'}]}]}, {'title': 'Exemestane', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '-0.5'}]}]}, {'title': 'Letrozole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '0'}]}]}, {'title': 'Tamoxifen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-1.75', 'upperLimit': '-1'}]}]}], 'analyses': [{'pValue': '0.7395', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons', 'groupDescription': 'In order to compare the response between groups, Kruskal-Wallis ANOVA was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Itching and current endocrine therapy)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.'}, {'type': 'SECONDARY', 'title': 'Change in Vaginal Dryness Symptom Scores by Prior Cytotoxic Therapy Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '-1'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-1'}]}]}], 'analyses': [{'pValue': '0.9618', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons', 'groupDescription': 'In order to compare the response between groups, Kruskal-Wallis ANOVA was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Dryness and prior cytotoxic therapy)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.'}, {'type': 'SECONDARY', 'title': 'Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-2.25', 'upperLimit': '-1'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-2'}]}]}], 'analyses': [{'pValue': '0.5113', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons', 'groupDescription': 'In order to compare the response between groups, Kruskal-Wallis ANOVA was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Dyspareunia and prior cytotoxic therapy)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.'}, {'type': 'SECONDARY', 'title': 'Change in Vaginal Itching Symptom Scores by Prior Cytotoxic Therapy Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '0'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '0.8833', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons', 'groupDescription': 'In order to compare the response between groups, Kruskal-Wallis ANOVA was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Itching and prior cytotoxic therapy)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.'}, {'type': 'SECONDARY', 'title': 'Change in Vaginal Dryness Symptom Scores by Indication for Endocrine Therapy Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'title': 'Adjuvant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '-1'}]}]}, {'title': 'Prophylaxis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-3'}]}]}], 'analyses': [{'pValue': '0.7983', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons', 'groupDescription': 'In order to compare the response between groups, Kruskal-Wallis ANOVA was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Dryness and Indications)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.'}, {'type': 'SECONDARY', 'title': 'Change in Dyspareunia Symptom Scores by Indication for Endocrine Therapy Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'title': 'Adjuvant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-1.75'}]}]}, {'title': 'Prophylaxis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data for single participant is missing', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.4937', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons', 'groupDescription': 'In order to compare the response between groups, Kruskal-Wallis ANOVA was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Dyspareunia and Indications)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.'}, {'type': 'SECONDARY', 'title': 'Change in Vaginal Itching Symptom Scores by Indication for Endocrine Therapy Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'title': 'Adjuvant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-1.75', 'upperLimit': '0'}]}]}, {'title': 'Prophylaxis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '-2'}]}]}], 'analyses': [{'pValue': '0.9106', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons', 'groupDescription': 'In order to compare the response between groups, Kruskal-Wallis ANOVA was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Itching and Indications)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.'}, {'type': 'SECONDARY', 'title': 'Change in Vaginal Dryness Symptom Scores by Patient Reported Compliance Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'title': '50 - 74%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '-2'}]}]}, {'title': '>= 75%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-1'}]}]}, {'title': 'Missing / not reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data is missing for these patients', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.507', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons', 'groupDescription': 'In order to compare the response between groups, Kruskal-Wallis ANOVA was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with patient reported compliance (Dryness)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.\n\nGroups are made by % of compliance reported by patients', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.'}, {'type': 'SECONDARY', 'title': 'Change in Dyspareunia Symptom Scores by Patient Reported Compliance Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'title': '50 - 74%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data is missing; could not calculate', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '>= 75%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-1.75'}]}]}, {'title': 'Missing / not reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data is missing; could not calculate', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.3676', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons', 'groupDescription': 'In order to compare the response between groups, Kruskal-Wallis ANOVA was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with patient reported compliance (Dyspareunia)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.\n\nGroups are made by % of compliance reported by patients', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.'}, {'type': 'SECONDARY', 'title': 'Change in Vaginal Itching Symptom Scores by Patient Reported Compliance Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'title': '50 - 74%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '-1'}]}]}, {'title': '>= 75%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '0'}]}]}, {'title': 'Missing / not reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data is missing; could not calculate.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.6023', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons', 'groupDescription': 'In order to compare the response between groups, Kruskal-Wallis ANOVA was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with patient reported compliance (Itching)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.\n\nGroups are made by % of compliance reported by patients', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.'}, {'type': 'SECONDARY', 'title': 'Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'title': '< 25%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '-1'}]}]}, {'title': '25 - 49%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-1.75'}]}]}, {'title': '50 - 74%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-1.75'}]}]}, {'title': '>= 75%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '-2'}]}]}, {'title': 'Missing / not reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-3.25', 'upperLimit': '-1.75'}]}]}], 'analyses': [{'pValue': '0.08531', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons', 'groupDescription': 'In order to compare the response between groups, Kruskal-Wallis ANOVA was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with tube weight based compliance (Dryness)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.\n\nGroups are made by % of tube used by weight.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.'}, {'type': 'SECONDARY', 'title': 'Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'title': '< 25%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '-1'}]}]}, {'title': '25 - 49%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '-1.5'}]}]}, {'title': '50 - 74%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-2.25', 'upperLimit': '-1.75'}]}]}, {'title': '>= 75%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-2.25', 'upperLimit': '-2'}]}]}, {'title': 'Missing / not reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-3'}]}]}], 'analyses': [{'pValue': '0.2011', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons', 'groupDescription': 'In order to compare the response between groups, Kruskal-Wallis ANOVA was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with tube weight based compliance (Dyspareunia)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.\n\nGroups are made by % of tube used by weight.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.'}, {'type': 'SECONDARY', 'title': 'Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'classes': [{'title': '< 25%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '-1'}]}]}, {'title': '25 - 49%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '0'}]}]}, {'title': '50 - 74%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '0'}]}]}, {'title': '>= 75%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '-0.5'}]}]}, {'title': 'Missing / not reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '-0.5'}]}]}], 'analyses': [{'pValue': '0.1187', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons', 'groupDescription': 'In order to compare the response between groups, Kruskal-Wallis ANOVA was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with tube weight based compliance (Itching)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.\n\nGroups are made by % of tube used by weight.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Supportive Care (Fluocinonide Cream)', '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Supportive Care', '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.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.44', 'spread': '9.39', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Menopause status', 'classes': [{'categories': [{'title': 'Pre-menopausal', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Post-menopausal', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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.", 'unitOfMeasure': 'Participants'}, {'title': 'Current endocrine therapy', 'classes': [{'categories': [{'title': 'Anastrazole', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Exemestane', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Letrozole', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Tamoxifen', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'type of endocrine therapy currently taken by the subject\n\ntamoxifen vs. anastrazole vs. letrozole vs. exemestane', 'unitOfMeasure': 'Participants'}, {'title': 'Prior cytotoxic chemotherapy received', 'classes': [{'categories': [{'title': 'Prior cytotoxic chemotherapy', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'No prior cytotoxic chemotherapy', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Whether the subject has received prior cytotoxic chemotherapy for breast cancer: prior cytotoxic chemotherapy versus no prior cytotoxic chemotherapy for breast cancer', 'unitOfMeasure': 'Participants'}, {'title': 'Indications for endocrine therapy', 'classes': [{'categories': [{'title': 'Adjuvant', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Prophylaxis', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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', 'unitOfMeasure': 'Participants'}, {'title': 'Severe baseline symptoms, Dryness', 'classes': [{'categories': [{'title': 'Severe', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Not severe', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Severe symptoms indicated by a score of 3 or 4. Measured at study baseline', 'unitOfMeasure': 'Participants'}, {'title': 'Severe baseline symptoms, Dyspareunia', 'classes': [{'categories': [{'title': 'Severe', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Not severe', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Missing/not reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Severe symptoms indicated by a score of 3 or 4. Measured at study baseline', 'unitOfMeasure': 'Participants'}, {'title': 'Severe baseline symptoms, Itching', 'classes': [{'categories': [{'title': 'Severe', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not severe', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Severe symptoms indicated by a score of 3 or 4. Measured at study baseline', '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.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'dispFirstSubmitDate': '2016-10-26', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-07', 'studyFirstSubmitDate': '2011-08-22', 'dispFirstSubmitQcDate': '2016-10-26', 'resultsFirstSubmitDate': '2017-03-29', 'studyFirstSubmitQcDate': '2011-08-22', 'dispFirstPostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-07', 'studyFirstPostDateStruct': {'date': '2011-08-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Symptom Scores of Vaginal Dryness', 'timeFrame': 'Baseline and 4 weeks', '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.'}, {'measure': 'Change in Symptom Scores of Dyspareunia', 'timeFrame': 'Baseline and 4 weeks', '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Symptom Scores of Vaginal Itching', 'timeFrame': 'Baseline and 4 weeks', '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.'}, {'measure': 'Change in Total Vaginal Index Score.', 'timeFrame': 'Baseline and 4 weeks', '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.'}, {'measure': 'Number of Patients Experiencing Toxicities', 'timeFrame': 'Over 4 weeks', 'description': 'Toxicity data will be reported as descriptive data as the percentage of patients experiencing reported side effects. Toxicity and safety analyses will be conducted using the safety analysis set.'}, {'measure': 'Change in Vaginal Dryness Symptom Scores by Age Characteristics', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Dryness and Age)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.'}, {'measure': 'Change in Dyspareunia Symptom Scores by Age Characteristics', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Dyspareunia and Age)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.'}, {'measure': 'Change in Vaginal Itching Symptom Scores by Age Characteristics', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Itching and Age)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.'}, {'measure': 'Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Dryness and Menopause status)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.'}, {'measure': 'Change in Dyspareunia Symptom Scores by Menopause Status Characteristics', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Dyspareunia and Menopause status)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.'}, {'measure': 'Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Itching and Menopause status)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.'}, {'measure': 'Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Dryness and current endocrine therapy)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.'}, {'measure': 'Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Dyspareunia and current endocrine therapy)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.'}, {'measure': 'Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Itching and current endocrine therapy)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.'}, {'measure': 'Change in Vaginal Dryness Symptom Scores by Prior Cytotoxic Therapy Characteristics', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Dryness and prior cytotoxic therapy)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.'}, {'measure': 'Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Dyspareunia and prior cytotoxic therapy)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.'}, {'measure': 'Change in Vaginal Itching Symptom Scores by Prior Cytotoxic Therapy Characteristics', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Itching and prior cytotoxic therapy)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.'}, {'measure': 'Change in Vaginal Dryness Symptom Scores by Indication for Endocrine Therapy Characteristics', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Dryness and Indications)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.'}, {'measure': 'Change in Dyspareunia Symptom Scores by Indication for Endocrine Therapy Characteristics', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Dyspareunia and Indications)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.'}, {'measure': 'Change in Vaginal Itching Symptom Scores by Indication for Endocrine Therapy Characteristics', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with characteristics of the subject population (Itching and Indications)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.'}, {'measure': 'Change in Vaginal Dryness Symptom Scores by Patient Reported Compliance Characteristics', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with patient reported compliance (Dryness)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.\n\nGroups are made by % of compliance reported by patients'}, {'measure': 'Change in Dyspareunia Symptom Scores by Patient Reported Compliance Characteristics', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with patient reported compliance (Dyspareunia)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.\n\nGroups are made by % of compliance reported by patients'}, {'measure': 'Change in Vaginal Itching Symptom Scores by Patient Reported Compliance Characteristics', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with patient reported compliance (Itching)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.\n\nGroups are made by % of compliance reported by patients'}, {'measure': 'Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with tube weight based compliance (Dryness)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.\n\nGroups are made by % of tube used by weight.'}, {'measure': 'Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with tube weight based compliance (Dyspareunia)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.\n\nGroups are made by % of tube used by weight.'}, {'measure': 'Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Association of response in symptoms with tube weight based compliance (Itching)\n\nDetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight.\n\nResponse in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). 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).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.\n\nGroups are made by % of tube used by weight.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Carcinoma']}, 'descriptionModule': {'briefSummary': 'This phase II trial studies how well giving fluocinonide cream works in treating symptoms of vaginal dryness and painful sexual intercourse in patients with breast cancer undergoing hormone therapy. Fluocinonide cream may prevent or lessen vaginal dryness and painful sexual intercourse in patients undergoing hormone therapy.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To estimate the decrease in symptoms of vaginal dryness and dyspareunia with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast cancer on endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments.\n\nSECONDARY OBJECTIVES:\n\nI. To estimate the decrease in symptoms of vaginal itching and the total vaginal index score with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast cancer on endocrine therapy. Estimates of decrease will be obtained utilizing patient survey instruments.\n\nII. To explore toxicities reported by subjects using fluocinonide 0.05% cream via vaginal application.\n\nIII. To explore correlation between subject reported compliance, as well as compliance via measurement of the amount of fluocinonide 0.05% cream used, and response rates with the use of fluocinonide 0.05% cream.\n\nIV. To explore the correlations between patient characteristics and response rates with the use of fluocinonide 0.05% cream.\n\nOUTLINE:\n\nPatients apply topical fluocinonide cream twice daily (BID) in weeks 1-2 and once daily (QD) in weeks 3-4.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult women (both pre-menopausal and post-menopausal women are eligible) and with a history of breast cancer or with an increased risk for breast cancer on current treatment with tamoxifen or an aromatase inhibitor with the presence of vaginal dryness or dyspareunia of sufficient severity to make the subject patient desire therapeutic intervention\n* Vaginal dryness or dyspareunia must be present for at least two months prior to study entry\n* Subjects must be on current treatment with tamoxifen or an aromatase inhibitor for at least two months prior to study enrollment (defined as the date of consent) and should not be planning to discontinue treatment or to change dose or type of endocrine treatment during the duration of the study\n* Subjects must agree to not use any over-the-counter or prescription vaginal preparations (lubricants, creams, gels, ointments, solutions) during the four weeks of treatment with topical fluocinonide cream\n* Subjects must agree to not use any medications, products, or preparations known to contain estrogen during the four weeks of treatment with topical fluocinonide cream\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\< 2\n* Subjects must have ability to read, comprehend, and complete patient questionnaires independently or with assistance\n* Subjects must sign informed consent\n* Subjects must agree to read patient instructions regarding use of barrier contraceptive devices while on treatment with fluocinonide cream in the informed consent\n\nExclusion Criteria:\n\n* Use of any vaginal preparations within one week prior to study enrollment (exception: subjects currently using a vaginal preparation can enroll after discontinuing treatment for 7 days)\n* Use of any estrogen containing medications, products, or preparations\n* Use of any systemic oral or parenteral steroid containing medications is not permitted; use of "High Daily Dose" inhaled/intranasal corticosteroids is not permitted; use inhaled/intranasal corticosteroid preparations at dosing levels less than "High Daily Dose" is permitted\n* Current or past treatment with fluocinonide cream for vaginal dryness, itching, or dyspareunia\n* Subject reported symptoms of vaginal infection with significant vaginal discharge or odor\n* Known current vaginal infection\n* Known vaginal pathology other than vaginal atrophy that could explain vaginal symptoms\n* Known intolerance of topical steroid preparations\n* Pregnant or lactating women (to be obtained via subject report only)\n* Known diagnoses of diabetes mellitus, adrenal insufficiency (Addison\'s disease), or Cushing\'s syndrome\n* No prior chemotherapeutic treatment for any malignancy other than breast cancer'}, 'identificationModule': {'nctId': 'NCT01422408', 'briefTitle': 'Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy', 'organization': {'class': 'OTHER', 'fullName': 'OHSU Knight Cancer Institute'}, 'officialTitle': 'Phase II Study of the Effect of the Topical Corticosteroid Fluocinonide in Patients on Endocrine Therapy for Either Breast Cancer or an Increased Risk for Breast Cancer With Symptoms of Vaginal Dryness and Dyspareunia', 'orgStudyIdInfo': {'id': 'IRB00007265'}, 'secondaryIdInfos': [{'id': 'NCI-2011-01234', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CPC-11028-L', 'type': 'OTHER', 'domain': 'OHSU Knight Cancer Institute'}, {'id': '7265', 'type': 'OTHER', 'domain': 'OHSU Knight Cancer Institute'}, {'id': 'P30CA69533OD', 'type': 'OTHER_GRANT', 'domain': 'National Cancer Institute'}, {'id': 'P30CA069533', 'link': 'https://reporter.nih.gov/quickSearch/P30CA069533', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive care (fluocinonide cream)', 'description': 'Patients apply topical fluocinonide cream BID in weeks 1-2 and QD in weeks 3-4.', 'interventionNames': ['Drug: Fluocinonide Cream', 'Procedure: Management of Therapy Complications', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Fluocinonide Cream', 'type': 'DRUG', 'otherNames': ['fluocinonide', 'Lidex', 'Vanos'], 'description': 'Given topically', 'armGroupLabels': ['Supportive care (fluocinonide cream)']}, {'name': 'Management of Therapy Complications', 'type': 'PROCEDURE', 'otherNames': ['complications of therapy, management of'], 'description': 'Receive fluocinonide cream', 'armGroupLabels': ['Supportive care (fluocinonide cream)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive care (fluocinonide cream)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'OHSU Knight Cancer Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Kathleen Kemmer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OHSU Knight Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OHSU Knight Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kathleen Kemmer', 'investigatorAffiliation': 'OHSU Knight Cancer Institute'}}}}