Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT01370551
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2011-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059268', 'term': 'Atrophic Vaginitis'}], 'ancestors': [{'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004964', 'term': 'Estriol'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bassfeld.doerthe@medinova.ch', 'phone': '+41 44 306 1371', 'title': 'Doerthe Bassfeld', 'organization': 'Medinova'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The weaknesses of the study were small numbers for testing of some parameters (especially dyspareunia).'}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Gynoflor', 'description': 'Gynoflor vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol:1 x 28 days, then 3x per week x 8 weeks', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 14, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastro-intestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza-like ilness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear and Labyrinth disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Serum Concentrations of Estriol (E3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gynoflor', 'description': 'Gynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; once daily for 28 days then 3 times per week for 8 weeks;'}], 'classes': [{'title': '-0.5 h (Day 0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': '-0.5 h (Day 28)', 'categories': [{'measurements': [{'value': '0.91', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '14.5'}]}]}, {'title': '0.5 h (Day 0)', 'categories': [{'measurements': [{'value': '3.83', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '14.10'}]}]}, {'title': '0.5 h (Day 28)', 'categories': [{'measurements': [{'value': '1.58', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '12.90'}]}]}, {'title': '1 h (Day 0)', 'categories': [{'measurements': [{'value': '11.04', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '18.8'}]}]}, {'title': '1 h (Day 28)', 'categories': [{'measurements': [{'value': '1.55', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '14.40'}]}]}, {'title': '2 h (Day 0)', 'categories': [{'measurements': [{'value': '72.73', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '168'}]}]}, {'title': '2 h (Day 28)', 'categories': [{'measurements': [{'value': '1.96', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '16.60'}]}]}, {'title': '3 h (Day 0)', 'categories': [{'measurements': [{'value': '84.35', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '160.00'}]}]}, {'title': '3 h (Day 28)', 'categories': [{'measurements': [{'value': '2.48', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '29.20'}]}]}, {'title': '4 h (Day 0)', 'categories': [{'measurements': [{'value': '28.29', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '67.50'}]}]}, {'title': '4 h (Day 28)', 'categories': [{'measurements': [{'value': '3.12', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '37.70'}]}]}, {'title': '6 h (Day 0)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': '6 h (Day 28)', 'categories': [{'measurements': [{'value': '7.33', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '39.50'}]}]}, {'title': '8 h (Day 0)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': '8 h (Day 28)', 'categories': [{'measurements': [{'value': '10.23', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '43.70'}]}]}, {'title': '24 h (Day 0)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': '24 h (Day 28)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}], 'paramType': 'MEAN', 'timeFrame': '-0.5, 0.5, 1, 2, 3, 4, 6, 8, 24 hours on days 0 and 28', 'description': 'Estrogens were analyzed using a highly sensitive gas chromatography-mass spectrometry (GC/MS) method. The lower limits of quantitation (LLOQ) were 10.00 pg/ml for E3, 1.The coefficient of variation (CV, intra-assay variation) was 2.0 % for E3 (calibration range (CR) 10.00-500.00 pg/).\n\nThe lower limits of quantitation (LLOQ) were 1.00 pg/ml for E2, and 2.00 pg/ml for E1.The coefficient of variation (CV, intra-assay variation) was 4.2 % for E2 (CR 1.00-150.00 pg/ml), and 3.4 % for E1 (CR 2.00-300.00 pg/ml).', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Calculation of Pharmacokinetic Parameters Estriol: Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gynoflor', 'description': 'Gynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; Once daily for 28 days then 3 times per week for 8 weeks;'}], 'classes': [{'title': 'Cmax (Day 0)', 'categories': [{'measurements': [{'value': '104.5', 'spread': '40.9', 'groupId': 'OG000'}]}]}, {'title': 'Cmax (Day 28)', 'categories': [{'measurements': [{'value': '15.8', 'spread': '13.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0 and 28', 'description': 'Cmax is the highest measured concentration', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Baseline / Trough Serum Concentrations of Estriol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gynoflor', 'description': 'This study consists only of this arm.\n\nGynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; Once daily for 28 days then 3 times per week for 8 weeks;'}], 'classes': [{'title': 'Estriol (Day 0)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Estriol (Day 14)', 'categories': [{'measurements': [{'value': '5.11', 'spread': '14.01', 'groupId': 'OG000'}]}]}, {'title': 'Estriol (Day 28)', 'categories': [{'measurements': [{'value': '0.91', 'spread': '3.63', 'groupId': 'OG000'}]}]}, {'title': 'Estriol (Day 56)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Estriol (Day 84)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0, 14, 28, 56 and 84', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP'}, {'type': 'SECONDARY', 'title': 'Vaginal pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gynoflor', 'description': 'Gynoflor vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol:1 x 28 days, then 3x per week x 8 weeks'}], 'classes': [{'title': 'Entry (Day 0)', 'categories': [{'measurements': [{'value': '6.0', 'spread': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'C1 (Day 14)', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'C2 (Day 28)', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'C3 (Day 56)', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'C4 (Day 84)', 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at all visits during 12 weeks', 'description': 'The normal vaginal pH is 3.8-5.0 pH is a logarithmic scale used to specify the acidity or basicity of aqueous solutions. The scale has values ranging from zero (the most acidic) to 14 (the most basic). Pure water has a pH value of 7. This value is considered neutral-neither acidic or basic.', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Calculation of Pharmacokinetic Parameters Estriol: Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gynoflor', 'description': 'Gynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; Once daily for 28 days then 3 times per week for 8 weeks;'}], 'classes': [{'title': 'Tmax (Day 0)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Tmax (Day 28)', 'categories': [{'measurements': [{'value': '7.2', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0 and 28', 'description': 'Tmax is the peak time at which the Cmax (maximum concentration) was measured', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Calculation of Pharmacokinetic Parameters Estriol: Area Under the Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gynoflor', 'description': 'Gynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; Once daily for 28 days then 3 times per week for 8 weeks;'}], 'classes': [{'title': 'AUC (0-24h) (Day 0)', 'categories': [{'measurements': [{'value': '212', 'spread': '93.2', 'groupId': 'OG000'}]}]}, {'title': 'AUC (0-24h) (Day 28)', 'categories': [{'measurements': [{'value': '130.7', 'spread': '147.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0 and 28', 'description': 'Area under the curve from administration to the last measured concentration (AUC0-24)', 'unitOfMeasure': 'hours * pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP'}, {'type': 'SECONDARY', 'title': 'Baseline / Trough Serum Concentrations of Luteinizing Hormone (LH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gynoflor', 'description': 'Gynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; once daily for 28 days then 3 times per week for 8 weeks'}], 'classes': [{'title': 'LH (Day 0)', 'categories': [{'measurements': [{'value': '36.46', 'spread': '11.05', 'groupId': 'OG000'}]}]}, {'title': 'LH (Day 14)', 'categories': [{'measurements': [{'value': '34.52', 'spread': '12.18', 'groupId': 'OG000'}]}]}, {'title': 'LH (Day 28)', 'categories': [{'measurements': [{'value': '34.02', 'spread': '12.68', 'groupId': 'OG000'}]}]}, {'title': 'LH (Day 56)', 'categories': [{'measurements': [{'value': '34.2', 'spread': '49.87', 'groupId': 'OG000'}]}]}, {'title': 'LH (Day 84)', 'categories': [{'measurements': [{'value': '35.13', 'spread': '10.34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0, 14, 28, 56 and 84', 'unitOfMeasure': 'mIU/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP'}, {'type': 'SECONDARY', 'title': 'Baseline / Trough Serum Concentrations of Sex Hormone Binding Globulin (SHBG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gynoflor', 'description': 'This study consists only of this arm.\n\nGynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; Once daily for 28 days then 3 times per week for 8 weeks;'}], 'classes': [{'title': 'SHBG (Day 0)', 'categories': [{'measurements': [{'value': '73.04', 'spread': '29.66', 'groupId': 'OG000'}]}]}, {'title': 'SHBG (Day 14)', 'categories': [{'measurements': [{'value': '74.24', 'spread': '35.35', 'groupId': 'OG000'}]}]}, {'title': 'SHBG (Day 28)', 'categories': [{'measurements': [{'value': '71.29', 'spread': '31.88', 'groupId': 'OG000'}]}]}, {'title': 'SHBG (Day 56)', 'categories': [{'measurements': [{'value': '73.35', 'spread': '32.76', 'groupId': 'OG000'}]}]}, {'title': 'SHBG (Day 84)', 'categories': [{'measurements': [{'value': '72.43', 'spread': '34.57', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0, 14, 28, 56 and 84', 'unitOfMeasure': 'nmol/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP'}, {'type': 'SECONDARY', 'title': 'Baseline / Trough Serum Concentrations of Follicule Stimulating Hormone (FSH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gynoflor', 'description': 'This study consists only of this arm.\n\nGynoflor: Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; Once daily for 28 days then 3 times per week for 8 weeks;'}], 'classes': [{'title': 'FSH (Day 0)', 'categories': [{'measurements': [{'value': '107.88', 'spread': '48.62', 'groupId': 'OG000'}]}]}, {'title': 'FSH (Day 14)', 'categories': [{'measurements': [{'value': '103.71', 'spread': '39.76', 'groupId': 'OG000'}]}]}, {'title': 'FSH (Day 28)', 'categories': [{'measurements': [{'value': '98.94', 'spread': '34.95', 'groupId': 'OG000'}]}]}, {'title': 'FSH (Day 56)', 'categories': [{'measurements': [{'value': '103.55', 'spread': '37.53', 'groupId': 'OG000'}]}]}, {'title': 'FSH (Day 84)', 'categories': [{'measurements': [{'value': '105.93', 'spread': '43.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 0, 14, 28, 56 and 84', 'unitOfMeasure': 'mIU/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gynoflor', 'description': 'Gynoflor vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol:1 x 28 days, then 3x per week x 8 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Enrolled', 'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Analyzed', 'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Gynoflor', 'description': 'Gynoflor vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol: 1 x 28 days, then 3x per week x 8 weeks'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000', 'lowerLimit': '52', 'upperLimit': '63'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Estriol', 'classes': [{'categories': [{'measurements': [{'value': '104.5', 'spread': '40.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Follicule Stimulating Hormone (FSH)', 'classes': [{'categories': [{'measurements': [{'value': '107.88', 'spread': '48.62', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mIU/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Luteinizing hormone (LH)', 'classes': [{'categories': [{'measurements': [{'value': '36.46', 'spread': '11.05', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mIU/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex hormone binding globulin (SHBG)', 'classes': [{'categories': [{'measurements': [{'value': '73.04', 'spread': '29.66', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'nmol/l', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Vaginal maturation index (VMI)', 'classes': [{'categories': [{'measurements': [{'value': '31.2', 'spread': '19.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The vaginal maturation index (VMI) was based on the percentages of superficial (X3) and intermediate (X2) epithelial cells present in the vaginal smear, and was calculated according to the following formula: VMI= 0.5(X2) + 1(X3)', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Lactobacillary grade (LBG)', 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '0.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'LBG I Normal Predominantly lactobacillary morphotypes with few coccoid bacteria, LBG IIa Slightly disturbed Slightly disturbed, fairly normal, LBG IIb Moderately disturbed Moderately disturbed, rather abnormal, LBG III Abnormal Abundant other bacteria but no or few Lactobacilli present\n\nFor the analysis, each of the categories were assigned a numeric score (LBG I= 1, LBG IIa= 2, LBG IIb= 3, LBG III= 4) where lower values indicate a better outcome', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Bacterial vaginosis (BV) score', 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '* Score 0: no BV flora present\n* Score 1: partial BV\n* Score 2: full BV', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2011-05-10', 'resultsFirstSubmitDate': '2023-03-15', 'studyFirstSubmitQcDate': '2011-06-08', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-10', 'studyFirstPostDateStruct': {'date': '2011-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Concentrations of Estriol (E3)', 'timeFrame': '-0.5, 0.5, 1, 2, 3, 4, 6, 8, 24 hours on days 0 and 28', 'description': 'Estrogens were analyzed using a highly sensitive gas chromatography-mass spectrometry (GC/MS) method. The lower limits of quantitation (LLOQ) were 10.00 pg/ml for E3, 1.The coefficient of variation (CV, intra-assay variation) was 2.0 % for E3 (calibration range (CR) 10.00-500.00 pg/).\n\nThe lower limits of quantitation (LLOQ) were 1.00 pg/ml for E2, and 2.00 pg/ml for E1.The coefficient of variation (CV, intra-assay variation) was 4.2 % for E2 (CR 1.00-150.00 pg/ml), and 3.4 % for E1 (CR 2.00-300.00 pg/ml).'}, {'measure': 'Calculation of Pharmacokinetic Parameters Estriol: Cmax', 'timeFrame': 'Days 0 and 28', 'description': 'Cmax is the highest measured concentration'}, {'measure': 'Calculation of Pharmacokinetic Parameters Estriol: Tmax', 'timeFrame': 'Days 0 and 28', 'description': 'Tmax is the peak time at which the Cmax (maximum concentration) was measured'}, {'measure': 'Calculation of Pharmacokinetic Parameters Estriol: Area Under the Curve (AUC)', 'timeFrame': 'Days 0 and 28', 'description': 'Area under the curve from administration to the last measured concentration (AUC0-24)'}], 'secondaryOutcomes': [{'measure': 'Baseline / Trough Serum Concentrations of Estriol', 'timeFrame': 'Days 0, 14, 28, 56 and 84'}, {'measure': 'Vaginal pH', 'timeFrame': 'at all visits during 12 weeks', 'description': 'The normal vaginal pH is 3.8-5.0 pH is a logarithmic scale used to specify the acidity or basicity of aqueous solutions. The scale has values ranging from zero (the most acidic) to 14 (the most basic). Pure water has a pH value of 7. This value is considered neutral-neither acidic or basic.'}, {'measure': 'Baseline / Trough Serum Concentrations of Luteinizing Hormone (LH)', 'timeFrame': 'Days 0, 14, 28, 56 and 84'}, {'measure': 'Baseline / Trough Serum Concentrations of Sex Hormone Binding Globulin (SHBG)', 'timeFrame': 'Days 0, 14, 28, 56 and 84'}, {'measure': 'Baseline / Trough Serum Concentrations of Follicule Stimulating Hormone (FSH)', 'timeFrame': 'Days 0, 14, 28, 56 and 84'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrophic Vaginitis']}, 'referencesModule': {'references': [{'pmid': '24718774', 'type': 'RESULT', 'citation': 'Donders G, Neven P, Moegele M, Lintermans A, Bellen G, Prasauskas V, Grob P, Ortmann O, Buchholz S. Ultra-low-dose estriol and Lactobacillus acidophilus vaginal tablets (Gynoflor((R))) for vaginal atrophy in postmenopausal breast cancer patients on aromatase inhibitors: pharmacokinetic, safety, and efficacy phase I clinical study. Breast Cancer Res Treat. 2014 Jun;145(2):371-9. doi: 10.1007/s10549-014-2930-x. Epub 2014 Apr 10.'}, {'pmid': '25427450', 'type': 'RESULT', 'citation': 'Buchholz S, Mogele M, Lintermans A, Bellen G, Prasauskas V, Ortmann O, Grob P, Neven P, Donders G. Vaginal estriol-lactobacilli combination and quality of life in endocrine-treated breast cancer. Climacteric. 2015 Apr;18(2):252-9. doi: 10.3109/13697137.2014.991301. Epub 2015 Jan 20.'}, {'pmid': '26223323', 'type': 'RESULT', 'citation': 'Donders G, Bellen G, Neven P, Grob P, Prasauskas V, Buchholz S, Ortmann O. Effect of ultra-low-dose estriol and lactobacilli vaginal tablets (Gynoflor(R)) on inflammatory and infectious markers of the vaginal ecosystem in postmenopausal women with breast cancer on aromatase inhibitors. Eur J Clin Microbiol Infect Dis. 2015 Oct;34(10):2023-8. doi: 10.1007/s10096-015-2447-1. Epub 2015 Jul 30.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/24718774/', 'label': 'Publication of main results'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the long term safety and efficacy of the vaginal application of Gynoflor®, an extremely low dosed estrogen therapy with lactobacilli, on atrophic vaginitis in postmenopausal breast cancer patients who have been treated with aromatase inhibitors.', 'detailedDescription': 'Two center phase I pharmacokinetic study assessed circulating estrogens in breast cancer patients on a non-steroidal aromatase inhibitor (NSAI) with vaginal atrophy using vaginal ultra-low-dose 0.03 mg estriol (E3) and Lactobacillus combination vaginal tablets (Gynoflor). 16 women on nonsteroidal aromatase inhibitor with severe vaginal atrophy applied a daily vaginal tablet of Gynoflor for 28 days followed by a maintenance therapy of 3 tablets weekly for 8 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '52 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with breast cancer on non-steroidal AI therapy (AI therapy start at least 6 months ago, and are scheduled to receive them during the study)\n2. Postmenopausal and age ≥52 with cessation of menses for at least 12 months\n3. Age 52 - 75 years\n4. Clinical symptoms of vaginal atrophy\n5. Vaginal pH \\> 5.0\n6. Karnofsky score ≥80%\n7. Signed Informed Consent Form together with contractual capability\n\nExclusion Criteria:\n\n1. Local or systemic use of any other sexual hormones (estrogens, progestins, androgens), 6 months before and during study\n2. Local or systemic use of phytoestrogens or products known for or taken to improve vaginal mucosal function, risk of vaginal infections, or vulvovaginal symptoms, 4 weeks before and during study\n3. Local or systemic use of any other anti-infectives, 2 weeks before and during study\n4. Use of any other vaginal medication, vaginal rinses and/or moisturizers, gels containing xylocain or other analgesic products to decrease pain during intercourse, 1 week before and during study\n5. Known or suspected hypersensitivity or intolerance to the study medications, inclusive their excipients\n6. Suspicion of or clinically manifest sexually transmitted infections (infections with Neisseria gonorrhoea, Chlamydia trachomatis, Treponema pallidum, genital herpes, Trichomonas vaginalis, genital condylomata, HIV)\n7. Clinical evidence of vaginal infections requiring extra treatment\n8. Any infections of the upper genital tract\n9. Hysterectomy\n10. Genital haemorrhage of unknown origin\n11. Malignant or pre-cancerous conditions of the uterus, vulva and/or vagina (PAP smear less than 3 years ago)\n12. Acute thrombophlebitis, thromboembolic disorders or a history of these disorders in association with previous use of oestrogen preparations\n13. Abuse of alcohol or drugs\n14. All chronic illnesses which could influence the absorption, distribution, biotransformation or elimination of the test preparation\n15. Patient has a condition or is in a situation which, in the investigator's opinion, may put the patient in significant risk, may confound the study result, or may interfere significantly with the patient's participation in the study\n16. BMI lower than 18.5 or higher than 30\n17. Patient on steroidal AIs (aromasin)\n18. Vulvo-dermatological conditions (like Lichen sclerosus, Lichen rubrus, Psoriasis)\n19. Genital prolapses\n20. Endometriosis\n21. Use of antibiotics or chemotherapeuticals which are harmful to lactobacilli\n22. Participation of patient in another investigational drug study, with the exception of treatment optimisation studies with non-steroidal aromatase inhibitors (AI)s\n23. Previous participation in this study\n24. Patient is a relative of, or staff directly reporting to the investigator\n25. Patient is an employee of the sponsor"}, 'identificationModule': {'nctId': 'NCT01370551', 'acronym': 'Gynoflor', 'briefTitle': 'Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medinova AG'}, 'officialTitle': 'A Clinical Study of Pharmacokinetics, Efficacy and Safety of Vaginal Application of Lyophilised Lactobacilli and 0.03 mg Estriol (Gynoflor®) on Atrophic Vaginitis in Postmenopausal Breast Cancer Patients Treated With Aromatase Inhibitors', 'orgStudyIdInfo': {'id': '806109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gynoflor', 'description': 'Gynoflor vaginal tablets 1/day x 4 weeks, then 3/week for 8 weeks', 'interventionNames': ['Drug: Estriol 0.03 mg, lyophylized lactobacillus']}], 'interventions': [{'name': 'Estriol 0.03 mg, lyophylized lactobacillus', 'type': 'DRUG', 'otherNames': ['Gynoflor'], 'description': 'Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; Once daily for 28 days then 3 times per week for 8 weeks;', 'armGroupLabels': ['Gynoflor']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospital Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Regensburg', 'country': 'Germany', 'facility': 'Department of Obstetrics and Gynaecology, University of Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}], 'overallOfficials': [{'name': 'Patrick Neven, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Leuven, Belgium'}, {'name': 'Stefan Buchholz, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Obstetrics and Gynaecology, University of Regensburg, Germany'}, {'name': 'Gilbert Donders, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Femicare, University Hospital, Leuven, Belgium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medinova AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}