Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-30 @ 6:27 PM
Study NCT ID:
NCT03996603
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2019-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D059268', 'term': 'Atrophic Vaginitis'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kyleparkernorris@gmail.com', 'phone': '(205) 934-1704', 'title': 'Kyle Norris, MD Principal Investigator', 'organization': 'University of Alabama at Birmingham'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Conjugated Estrogens Cream', 'description': '0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks\n\nConjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Cohort', 'description': 'No intervention will be given.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quantitative Change in Relative Abundance of Lactobacillus Among the Community Composition of Bacteria in the Vagina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conjugated Estrogens Cream', 'description': '0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks\n\nConjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks'}, {'id': 'OG001', 'title': 'Control Cohort', 'description': 'No intervention will be given.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.14'}, {'value': '0.09', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.45'}]}]}, {'title': '8 weeks', 'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '0.96'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.04', 'upperLimit': '0.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'The relative abundance of the Lactobacillus genus, as measured by 16S ribosomal RNA (rRNA) gene sequencing, is the proportion of Lactobacillus genus among the total vaginal microbiome. After analysis of the gene sequencing, the total yield of bacteria at the genus level equals 1.\n\nThe quantitative change in relative abundance of Lactobacillus among the community composition of bacteria in the vagina will be assessed from baseline to 8 weeks. The investigators hypothesize that a pre-specified statistically significant quantitative increase in the relative abundance of Lactobacillus will be seen among the participants that receive treatment.', 'unitOfMeasure': 'Relative abundance', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Vaginal Maturation Index (VMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conjugated Estrogens Cream', 'description': '0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks\n\nConjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks'}, {'id': 'OG001', 'title': 'Control Cohort', 'description': 'No intervention will be given.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '47.5'}, {'value': '42.5', 'groupId': 'OG001', 'lowerLimit': '17.5', 'upperLimit': '50'}]}]}, {'title': '8 weeks', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '65'}, {'value': '47.5', 'groupId': 'OG001', 'lowerLimit': '45', 'upperLimit': '52.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'The maturation value (MV) is calculated with the following formula: MV = % surface cells + (0.5 × % intermediate cells).\n\nThe outcome data is reported as the delta change from baseline to 8 weeks.\n\nThe data for the primary outcome has been entered using the "measure type - NUMBER" because the outcome is a delta or change in the vaginal maturation index.', 'unitOfMeasure': 'Change in vaginal maturation index value', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Vaginal pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conjugated Estrogens Cream', 'description': '0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks\n\nConjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks'}, {'id': 'OG001', 'title': 'Control Cohort', 'description': 'No intervention will be given.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.25', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '7.5'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '8.0'}]}]}, {'title': '8 weeks', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '5.5'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '7.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Change in the vaginal pH from baseline to 8 weeks', 'unitOfMeasure': 'Vaginal pH', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vaginal Inflammatory Biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conjugated Estrogens Cream', 'description': '0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks\n\nConjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks'}, {'id': 'OG001', 'title': 'Control Cohort', 'description': 'No intervention will be given.'}], 'classes': [{'title': 'IL-1b BASELINE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '84.9'}, {'value': '132.9', 'groupId': 'OG001', 'lowerLimit': '28.8', 'upperLimit': '236.9'}]}]}, {'title': 'IL-1b 8 WEEKS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '26.0'}, {'value': '373.6', 'groupId': 'OG001', 'lowerLimit': '10.2', 'upperLimit': '737.1'}]}]}, {'title': 'IL-4 BASELINE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '23.1'}, {'value': '18.1', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '33.8'}]}]}, {'title': 'IL-4 8 WEEKS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '4.2'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '17.2'}]}]}, {'title': 'IL-8 BASELINE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3158.2', 'groupId': 'OG000', 'lowerLimit': '1956.2', 'upperLimit': '8087.5'}, {'value': '3724.3', 'groupId': 'OG001', 'lowerLimit': '2254.4', 'upperLimit': '5194.2'}]}]}, {'title': 'IL-8 8 WEEKS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '757.5', 'groupId': 'OG000', 'lowerLimit': '260.0', 'upperLimit': '1980.3'}, {'value': '7941.0', 'groupId': 'OG001', 'lowerLimit': '2247.8', 'upperLimit': '13643.2'}]}]}, {'title': 'IL-10 BASELINE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000', 'lowerLimit': '14.9', 'upperLimit': '38.2'}, {'value': '12.7', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '22.1'}]}]}, {'title': 'IL-10 8 WEEKS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '640.7', 'comment': 'Only one specimen resulted a value for IL-10 post treatment.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '14.3'}]}]}, {'title': 'TNF-a BASELINE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '56.9'}, {'value': '11.6', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '39.7'}]}]}, {'title': 'TNF-a 8 WEEKS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '10.1'}, {'value': '12.0', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '30.5'}]}]}, {'title': 'MCP-1 BASELINE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '102.5', 'groupId': 'OG000', 'lowerLimit': '22.1', 'upperLimit': '232.1'}, {'value': '29.1', 'groupId': 'OG001', 'lowerLimit': '24.4', 'upperLimit': '186.7'}]}]}, {'title': 'MCP-1 8 WEEKS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '31.3'}, {'value': '59.0', 'groupId': 'OG001', 'lowerLimit': '19.8', 'upperLimit': '79.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Change in the vaginal inflammatory biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF from baseline to 8 weeks', 'unitOfMeasure': 'pg/mg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only one specimen resulted in a value for IL-10 post-treatment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quantitative and Qualitative Changes in the Distribution of Operational Taxonomic Units (OTUs) in the Bladder Microbiome.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conjugated Estrogens Cream', 'description': '0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks\n\nConjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks'}, {'id': 'OG001', 'title': 'Control Cohort', 'description': 'No intervention will be given.'}], 'timeFrame': 'Baseline, 8 weeks', 'description': 'Quantitative and qualitative changes in the distribution of operational taxonomic units (OTUs) from baseline to 8 weeks.', 'reportingStatus': 'POSTED', 'populationDescription': 'There was only one participant and there was no range.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quantitative and Qualitative Changes in the Distribution of Operational Taxonomic Units (OTUs) in the Rectal Microbiome.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conjugated Estrogens Cream', 'description': '0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks\n\nConjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks'}, {'id': 'OG001', 'title': 'Control Cohort', 'description': 'No intervention will be given.'}], 'timeFrame': 'Baseline, 8 weeks', 'description': 'Quantitative and qualitative changes in the distribution of operational taxonomic units (OTUs) from baseline to 8 weeks.', 'reportingStatus': 'POSTED', 'populationDescription': 'This data was never collected.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Bladder Inflammatory Biomarkers (IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conjugated Estrogens Cream', 'description': '0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks\n\nConjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks'}, {'id': 'OG001', 'title': 'Control Cohort', 'description': 'No intervention will be given.'}], 'timeFrame': 'Baseline, 8 weeks', 'description': 'Change in the concentration of bladder inflammatory biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF from baseline to 8 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'This data was never collected.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rectal Inflammatory Biomarkers (IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conjugated Estrogens Cream', 'description': '0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks\n\nConjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks'}, {'id': 'OG001', 'title': 'Control Cohort', 'description': 'No intervention will be given.'}], 'timeFrame': 'Baseline, 8 weeks', 'description': 'Change in the concentration of rectal inflammatory biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF from baseline to 8 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'This data was never collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Conjugated Estrogens Cream', 'description': '0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks\n\nConjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks'}, {'id': 'FG001', 'title': 'Control Cohort', 'description': 'No intervention will be given.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Conjugated Estrogens Cream', 'description': '0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks\n\nConjugated Estrogens Cream: 0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks'}, {'id': 'BG001', 'title': 'Control Cohort', 'description': 'No intervention will be given.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.5', 'groupId': 'BG000', 'lowerLimit': '57', 'upperLimit': '71'}, {'value': '71', 'groupId': 'BG001', 'lowerLimit': '61', 'upperLimit': '77'}, {'value': '66', 'groupId': 'BG002', 'lowerLimit': '57', 'upperLimit': '73'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '27.3', 'groupId': 'BG000', 'lowerLimit': '23.8', 'upperLimit': '30.9'}, {'value': '30.9', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '31.5'}, {'value': '27.3', 'groupId': 'BG002', 'lowerLimit': '22.4', 'upperLimit': '31.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Parity', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '1.5', 'upperLimit': '2'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'births', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Spontaneous Vaginal Delivery', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '0.5', 'upperLimit': '2'}, {'value': '1', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '0.5', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'deliveries', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Hysterectomy', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Prolapse Surgery', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior SUI Surgery', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Recurrent UTIs', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes Mellitus', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Currently on OAB/UUI Medication(s)', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Currently Sexually Active', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Vaginal pH', 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'groupId': 'BG000', 'lowerLimit': '6.5', 'upperLimit': '7.5'}, {'value': '7', 'groupId': 'BG001', 'lowerLimit': '5.5', 'upperLimit': '8'}, {'value': '7', 'groupId': 'BG002', 'lowerLimit': '6.25', 'upperLimit': '7.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pH', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Vaginal Maturation Index', 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '50'}, {'value': '40', 'groupId': 'BG001', 'lowerLimit': '35', 'upperLimit': '50'}, {'value': '40', 'groupId': 'BG002', 'lowerLimit': '10', 'upperLimit': '50'}]}]}], 'paramType': 'MEDIAN', 'description': 'The maturation value (MV) is calculated with the following formula: MV = % surface cells + (0.5 × % intermediate cells)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-24', 'size': 884967, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-19T14:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-10', 'studyFirstSubmitDate': '2019-06-11', 'resultsFirstSubmitDate': '2022-01-19', 'studyFirstSubmitQcDate': '2019-06-20', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-10', 'studyFirstPostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quantitative and Qualitative Changes in the Distribution of Operational Taxonomic Units (OTUs) in the Bladder Microbiome.', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Quantitative and qualitative changes in the distribution of operational taxonomic units (OTUs) from baseline to 8 weeks.'}, {'measure': 'Quantitative and Qualitative Changes in the Distribution of Operational Taxonomic Units (OTUs) in the Rectal Microbiome.', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Quantitative and qualitative changes in the distribution of operational taxonomic units (OTUs) from baseline to 8 weeks.'}, {'measure': 'Bladder Inflammatory Biomarkers (IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF)', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Change in the concentration of bladder inflammatory biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF from baseline to 8 weeks'}, {'measure': 'Rectal Inflammatory Biomarkers (IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF)', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Change in the concentration of rectal inflammatory biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF from baseline to 8 weeks'}], 'primaryOutcomes': [{'measure': 'Quantitative Change in Relative Abundance of Lactobacillus Among the Community Composition of Bacteria in the Vagina', 'timeFrame': 'Baseline, 8 weeks', 'description': 'The relative abundance of the Lactobacillus genus, as measured by 16S ribosomal RNA (rRNA) gene sequencing, is the proportion of Lactobacillus genus among the total vaginal microbiome. After analysis of the gene sequencing, the total yield of bacteria at the genus level equals 1.\n\nThe quantitative change in relative abundance of Lactobacillus among the community composition of bacteria in the vagina will be assessed from baseline to 8 weeks. The investigators hypothesize that a pre-specified statistically significant quantitative increase in the relative abundance of Lactobacillus will be seen among the participants that receive treatment.'}], 'secondaryOutcomes': [{'measure': 'Change in Vaginal Maturation Index (VMI)', 'timeFrame': 'Baseline, 8 weeks', 'description': 'The maturation value (MV) is calculated with the following formula: MV = % surface cells + (0.5 × % intermediate cells).\n\nThe outcome data is reported as the delta change from baseline to 8 weeks.\n\nThe data for the primary outcome has been entered using the "measure type - NUMBER" because the outcome is a delta or change in the vaginal maturation index.'}, {'measure': 'Change in Vaginal pH', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Change in the vaginal pH from baseline to 8 weeks'}, {'measure': 'Vaginal Inflammatory Biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Change in the vaginal inflammatory biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF from baseline to 8 weeks'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Genitourinary Syndrome of Menopause', 'Vaginal Atrophy', 'Vaginal Estrogen Therapy', 'Inflammatory Response', 'Microbial Colonization', 'Urinary Microbiome', 'Vaginal Microbiome', 'Rectal Microbiome', 'Conjugated Estrogen Cream'], 'conditions': ['Female Urogenital Diseases', 'Vaginal Atrophy', 'Postmenopausal Atrophic Vaginitis', 'Genitourinary Disease', 'Postmenopausal Symptoms']}, 'descriptionModule': {'briefSummary': 'In this proposed pilot study, 16S ribosomal RNA (rRNA) gene sequencing will be used in the analysis of bacterial communities (microbiomes) in postmenopausal women with vulvovaginal atrophy (VVA) before and after eight weeks of vaginal estrogen use. The investigators plan to characterize the composition and dynamics of the microbiomes of the vagina, bladder, and rectum for quantitative and qualitative changes in the distribution of operational taxonomic units (OTUs) before and after eight weeks of local vaginal estrogen therapy. Although the vagina, bladder, and gut microbiomes have been increasingly independently studied, less is known about the interactions of the bacterial communities among the three environments as well as the dynamic relationship with menopausal status and vaginal estrogen therapy and the investigators seek to elucidate these relationships further.', 'detailedDescription': "This is an open-label pilot study of vaginal estrogen therapy in postmenopausal participants with vulvovaginal atrophy. The investigators seek to evaluate the effects of vaginal estrogen therapy on the vaginal, urinary, and rectal bacterial communities (microbiomes) and assess the (i) quantitative change in relative abundance of Lactobacillus among the community composition of bacteria in the vagina, and (ii) to evaluate the vaginal maturation index (VMI), vaginal pH, and vaginal inflammatory biomarkers: IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF (IL - Interleukin, TNF - tumor necrosis factor, MCP - monocyte chemoattractant protein, GM - granulocyte macrophage, CSF - colony stimulating factor) and correlate any notable changes with changes noted in the vaginal microbiome, and (iii and iv) observe for quantitative and qualitative changes in the distribution of operational taxonomic units (OTUs) among the bladder and rectal microbiomes. These changes will also be compared to the results yielded from the vaginal microbiome analysis. Additionally the investigators will assess for quantitative changes in the bladder and rectal inflammatory biomarkers (IL-1B, IL-4, IL-6, IL-8, IL-10, TNF-a, MCP-1, GM-CSF) and correlate these findings with any notable changes in the bladder and rectal microbiomes. Furthermore, changes in these biomarkers will be compared with the data (inflammatory and microbial) yielded from vaginal sampling. Bio-specimens and patient questionnaires will be assessed at baseline and again after eight weeks of vaginal estrogen therapy.\n\n20 participants will receive the intervention (vaginal estrogen therapy) for 8 weeks. 5 participants who meet the same inclusion/exclusion criteria will not receive the intervention and will be sampled at the same time points. The additional 5 participants are intended to serve as a control cohort to demonstrate stability of the microbiome over the study period. The 5 participants may be compared to the 20 participants receiving therapy but that is not part of the primary or secondary outcomes.\n\nThe investigators believe that examining the dynamic relationships of the genitourinary-rectal region is innovative and vital to validating the investigator's understanding and assumptions of the pathophysiology and treatment approaches of this disorder."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal with vulvovaginal atrophy\n* Age ≥55 years old and a screening vaginal pH of ≥5.\n* Without menses for ≥12 months.\n* No uterovaginal or vaginal vault prolapse beyond the hymen.\n* No estrogen replacement within the last month (may come off current treatment, i.e. wash out, to join the study)\n\nExclusion Criteria:\n\n* Patients with BMI \\>35kg/m2\n* Any patients with infections requiring antibiotic or antifungal therapy during the study period.\n* Study patients may not use any vaginal suppositories, douches, or vaginal hygiene wipes within the month preceding enrollment. For patients already on hormone therapy, will be allowed to undergo a "wash out" period of estrogen or progesterone products for one month prior to enrollment.\n* Additional exclusions included patients with systemic conditions requiring immunosuppressive drugs, currently receiving chemotherapy, or history of pelvic radiation.\n* Any patients with contraindications to vaginal estrogen therapy including: vaginal bleeding of unknown etiology; known, suspected, or history of breast cancer or estrogen-dependent neoplasia; active DVT, PE, or h/o these conditions; active arterial thromboembolic disease (ie. stroke or MI) or h/o of these; known liver disease or thrombophilic disorders.\n* Current tobacco use.\n* Allergy to Premarin® or its constituents.\n* Concurrent use of steroid creams for other indications (ie. lichen sclerosis)'}, 'identificationModule': {'nctId': 'NCT03996603', 'acronym': 'IMPLORE', 'briefTitle': 'Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'IMPLORE Study: Investigation of Microbiomes of Postmenopausal Women Looking for Outcomes and Response to Estrogen Therapy', 'orgStudyIdInfo': {'id': 'IRB-300002968'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conjugated Estrogens Cream', 'description': '0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks', 'interventionNames': ['Drug: Conjugated Estrogens Cream']}, {'type': 'NO_INTERVENTION', 'label': 'Control Cohort', 'description': 'No intervention will be given.'}], 'interventions': [{'name': 'Conjugated Estrogens Cream', 'type': 'DRUG', 'otherNames': ['Premarin Vaginal Cream'], 'description': '0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks', 'armGroupLabels': ['Conjugated Estrogens Cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Kyle P Norris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor Fellow', 'investigatorFullName': 'Kyle P Norris, MD', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}