Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT00276094
Status:
COMPLETED
Last Update Posted:
2013-06-28
First Post:
2006-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'C119141', 'term': 'Ospemifene'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shionogiclintrialsadmin@shionogi.com', 'phone': '800-849-9707', 'title': 'Shionogi Clinical Trials Administrator', 'phoneExt': '1454', 'organization': 'Shionogi Inc.'}, 'certainAgreement': {'otherDetails': "The sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '16 weeks (Visit 2 [Randomization] to Visit 5)', 'eventGroups': [{'id': 'EG000', 'title': 'Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.', 'otherNumAtRisk': 282, 'otherNumAffected': 99, 'seriousNumAtRisk': 282, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.', 'otherNumAtRisk': 276, 'otherNumAffected': 99, 'seriousNumAtRisk': 276, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo Tablets and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.', 'otherNumAtRisk': 268, 'otherNumAffected': 49, 'seriousNumAtRisk': 268, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Fungal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Vulvovaginal Mycotic Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Vaginal Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Hot Flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Duodenal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Red Blood Cell Sedimentation Rate Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Breast Cancer Metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Psychotic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pulmonary Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Gastric Bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG002', 'title': 'Placebo Tablets and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.22', 'spread': '0.929', 'groupId': 'OG000'}, {'value': '-1.26', 'spread': '1.025', 'groupId': 'OG001'}, {'value': '-0.84', 'spread': '0.996', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Randomization) to Week 12', 'description': 'This outcome measure was analyzed using Cochran-Mantel-Haenszel (CMH) row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG002', 'title': 'Placebo Tablets and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.02', 'spread': '1.132', 'groupId': 'OG000'}, {'value': '-1.19', 'spread': '1.292', 'groupId': 'OG001'}, {'value': '-0.89', 'spread': '1.115', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Randomization) to Week 12', 'description': 'This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Vaginal pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}, {'value': '268', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG002', 'title': 'Placebo Tablets and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.67', 'spread': '1.054', 'groupId': 'OG000'}, {'value': '-1.01', 'spread': '1.053', 'groupId': 'OG001'}, {'value': '-0.096', 'spread': '0.8357', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Screening) to Week 12', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}, {'value': '268', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG002', 'title': 'Placebo Tablets and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.9', 'spread': '32.60', 'groupId': 'OG000'}, {'value': '-30.1', 'spread': '37.93', 'groupId': 'OG001'}, {'value': '3.98', 'spread': '35.205', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Screening) to Week 12', 'unitOfMeasure': 'percentage of parabasal cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Visual Evaluation of the Vagina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG002', 'title': 'Placebo Tablets and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}], 'classes': [{'title': 'Petechiae', 'categories': [{'measurements': [{'value': '-0.50', 'spread': '0.829', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.848', 'groupId': 'OG001'}, {'value': '-0.037', 'spread': '0.8080', 'groupId': 'OG002'}]}]}, {'title': 'Pallor', 'categories': [{'measurements': [{'value': '-0.75', 'spread': '0.914', 'groupId': 'OG000'}, {'value': '-0.93', 'spread': '0.930', 'groupId': 'OG001'}, {'value': '-0.30', 'spread': '0.940', 'groupId': 'OG002'}]}]}, {'title': 'Friability', 'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.922', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '0.911', 'groupId': 'OG001'}, {'value': '-0.16', 'spread': '0.818', 'groupId': 'OG002'}]}]}, {'title': 'Vaginal dryness in mucosa', 'categories': [{'measurements': [{'value': '-1.05', 'spread': '0.959', 'groupId': 'OG000'}, {'value': '-1.22', 'spread': '0.981', 'groupId': 'OG001'}, {'value': '-0.48', 'spread': '0.911', 'groupId': 'OG002'}]}]}, {'title': 'Vaginal redness in mucosa', 'categories': [{'measurements': [{'value': '-0.44', 'spread': '0.811', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.924', 'groupId': 'OG001'}, {'value': '-0.23', 'spread': '0.792', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Screening) to Week 12', 'description': 'Exam Rating Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of VVA Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}, {'value': '268', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG002', 'title': 'Placebo Tablets and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}], 'classes': [{'title': 'Vaginal dryness', 'categories': [{'measurements': [{'value': '-0.96', 'spread': '1.018', 'groupId': 'OG000'}, {'value': '-1.17', 'spread': '1.050', 'groupId': 'OG001'}, {'value': '-0.63', 'spread': '1.047', 'groupId': 'OG002'}]}]}, {'title': 'Vaginal pain associated with sexual activity', 'categories': [{'measurements': [{'value': '-0.77', 'spread': '1.200', 'groupId': 'OG000'}, {'value': '-0.87', 'spread': '1.278', 'groupId': 'OG001'}, {'value': '-0.57', 'spread': '1.224', 'groupId': 'OG002'}]}]}, {'title': 'Vulvar/vaginal itching or irritation', 'categories': [{'measurements': [{'value': '-0.40', 'spread': '1.080', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '0.982', 'groupId': 'OG001'}, {'value': '-0.44', 'spread': '0.948', 'groupId': 'OG002'}]}]}, {'title': 'Difficult/painful urination', 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.676', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.673', 'groupId': 'OG001'}, {'value': '-0.097', 'spread': '0.6745', 'groupId': 'OG002'}]}]}, {'title': 'Vaginal bleeding associated with sexual activity', 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.807', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.707', 'groupId': 'OG001'}, {'value': '-0.12', 'spread': '0.667', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Randomization) to Week 12', 'description': 'This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Estradiol Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG002', 'title': 'Placebo Tablets and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.44', 'spread': '19.01', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '12.74', 'groupId': 'OG001'}, {'value': '0.30', 'spread': '3.90', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Screening) to Week 12', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis populations for each hormone:\n\nOspemifene(30 mg): E2-231, FSH-232, LH-231, SHBG-232, Testosterone(free)-183, Testosterone(total)-183 Ospemifene(60 mg): E2-221, FSH-222, LH-222, SHBG-221, Testosterone(free)-175, Testosterone(total)-176 Placebo: E2-216, FSH-216, LH-216, SHBG-216, Testosterone(free)-178, Testosterone(total)-178'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}, {'value': '268', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG002', 'title': 'Placebo Tablets and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.78', 'spread': '12.136', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '15.66', 'groupId': 'OG001'}, {'value': '2.18', 'spread': '8.393', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Screening) to Week 12', 'unitOfMeasure': 'percentage of superficial cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Follicle Stimulating Hormone Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG002', 'title': 'Placebo Tablets and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.93', 'spread': '12.49', 'groupId': 'OG000'}, {'value': '-8.71', 'spread': '13.61', 'groupId': 'OG001'}, {'value': '-1.33', 'spread': '10.87', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Screening) to Week 12', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Luteinizing Hormone Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG002', 'title': 'Placebo Tablets and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.85', 'spread': '6.07', 'groupId': 'OG000'}, {'value': '-3.73', 'spread': '5.83', 'groupId': 'OG001'}, {'value': '0.41', 'spread': '7.25', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Screening) to Week 12', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sex Hormone Binding Globulin Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG002', 'title': 'Placebo Tablets and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'spread': '16.46', 'groupId': 'OG000'}, {'value': '22.8', 'spread': '22.06', 'groupId': 'OG001'}, {'value': '-2.17', 'spread': '12.02', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Screening) to Week 12', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Testosterone (Free) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG002', 'title': 'Placebo Tablets and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.002', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '-0.031', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-0.008', 'spread': '0.13', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Screening) to Week 12', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Testosterone (Total) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG002', 'title': 'Placebo Tablets and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.55', 'spread': '18.82', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '5.56', 'groupId': 'OG001'}, {'value': '-0.059', 'spread': '6.07', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Screening) to Week 12', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urinary Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'OG002', 'title': 'Placebo Tablets and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}], 'classes': [{'title': 'Frequent urination-Improved', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}, {'title': 'Frequent urination-Worsened', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Urine leakage (feeling of urgency)-Improved', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}]}, {'title': 'Urine leakage (feeling of urgency)-Worsened', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Urine leakage with physical exertion-Improved', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'Urine leakage with physical exertion-Worsened', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Small amount of urine leakage-Improved', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}]}, {'title': 'Small amount of urine leakage-Worsened', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Difficulty emptying bladder-Improved', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Difficulty emptying bladder-Worsened', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Pain in lower abdominal/genital area-Improved', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'Pain in lower abdominal or genital area-Worsened', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Randomization) to Week 12', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'FG001', 'title': 'Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'FG002', 'title': 'Placebo Tablets and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '282'}, {'groupId': 'FG001', 'numSubjects': '276'}, {'groupId': 'FG002', 'numSubjects': '268'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '225'}, {'groupId': 'FG001', 'numSubjects': '234'}, {'groupId': 'FG002', 'numSubjects': '230'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Other-Subject moved out of country', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other-Scheduled gastroplasty', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other-Lack of efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other-Refused follow-up visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other-Repeat safety labs-exclusionary', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other-Relocation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other-Study medication lost', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}, {'value': '826', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'BG001', 'title': 'Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'BG002', 'title': 'Placebo Tablets and Nonhormonal Vaginal Lubricant', 'description': 'Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.4', 'spread': '6.27', 'groupId': 'BG000'}, {'value': '58.6', 'spread': '6.34', 'groupId': 'BG001'}, {'value': '58.9', 'spread': '6.09', 'groupId': 'BG002'}, {'value': '58.6', 'spread': '6.23', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '282', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}, {'value': '826', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '253', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}, {'value': '744', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Missing value', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '265', 'groupId': 'BG000'}, {'value': '256', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '765', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Total number of participants in each arm/group do not match the "Overall Number of Baseline participants" in each Arm/group because "Race" and "Ethnicity" parameters have been combined to ensure faithful reproduction of each parameter, as mentioned in the CSR.', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '161.9', 'spread': '6.60', 'groupId': 'BG000'}, {'value': '162.1', 'spread': '6.42', 'groupId': 'BG001'}, {'value': '162.3', 'spread': '6.87', 'groupId': 'BG002'}, {'value': '162.1', 'spread': '6.62', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '69.2', 'spread': '13.06', 'groupId': 'BG000'}, {'value': '68.4', 'spread': '12.08', 'groupId': 'BG001'}, {'value': '69.0', 'spread': '12.90', 'groupId': 'BG002'}, {'value': '68.9', 'spread': '12.68', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.4', 'spread': '4.51', 'groupId': 'BG000'}, {'value': '26.0', 'spread': '4.44', 'groupId': 'BG001'}, {'value': '26.1', 'spread': '4.37', 'groupId': 'BG002'}, {'value': '26.2', 'spread': '4.43', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Intact Uterus?', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '379', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}, {'value': '447', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Intact Cervix?', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '395', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '431', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Number (No.) of Pregnancies', 'classes': [{'categories': [{'measurements': [{'value': '2.61', 'spread': '1.834', 'groupId': 'BG000'}, {'value': '2.39', 'spread': '1.638', 'groupId': 'BG001'}, {'value': '2.38', 'spread': '1.525', 'groupId': 'BG002'}, {'value': '2.46', 'spread': '1.675', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Pregnancies per participant', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'No. of Vaginal Births', 'classes': [{'categories': [{'measurements': [{'value': '1.78', 'spread': '1.565', 'groupId': 'BG000'}, {'value': '1.65', 'spread': '1.478', 'groupId': 'BG001'}, {'value': '1.59', 'spread': '1.386', 'groupId': 'BG002'}, {'value': '1.68', 'spread': '1.480', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Vaginal births per participant', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'No. of Urinary Tract Infections in Past 6 Months', 'classes': [{'title': 'Missing values', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': '0', 'categories': [{'measurements': [{'value': '247', 'groupId': 'BG000'}, {'value': '239', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}, {'value': '728', 'groupId': 'BG003'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': '4 or more', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Currently Experiencing Hot Flashes?', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': '325', 'groupId': 'BG003'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '501', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'No. of Days with Hot Flashes (/month)', 'classes': [{'categories': [{'measurements': [{'value': '19.7', 'spread': '11.68', 'groupId': 'BG000'}, {'value': '19.6', 'spread': '11.49', 'groupId': 'BG001'}, {'value': '19.6', 'spread': '11.09', 'groupId': 'BG002'}, {'value': '19.6', 'spread': '11.41', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Previous Hormone Treatment', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}, {'value': '672', 'groupId': 'BG003'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '154', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Partcipants'}, {'title': 'Percentage of Parabasal Cells at Screening', 'classes': [{'categories': [{'measurements': [{'value': '40.1', 'spread': '38.33', 'groupId': 'BG000'}, {'value': '39.3', 'spread': '38.98', 'groupId': 'BG001'}, {'value': '38.5', 'spread': '37.60', 'groupId': 'BG002'}, {'value': '39.3', 'spread': '38.28', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage of Parabasal Cells', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Percentage of Superficial Cells at Screening', 'classes': [{'categories': [{'measurements': [{'value': '1.25', 'spread': '2.907', 'groupId': 'BG000'}, {'value': '1.04', 'spread': '3.368', 'groupId': 'BG001'}, {'value': '0.91', 'spread': '2.635', 'groupId': 'BG002'}, {'value': '1.07', 'spread': '2.989', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage of Superficial Cells', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Vaginal pH at Screening', 'classes': [{'categories': [{'measurements': [{'value': '6.35', 'spread': '0.736', 'groupId': 'BG000'}, {'value': '6.37', 'spread': '0.763', 'groupId': 'BG001'}, {'value': '6.34', 'spread': '0.732', 'groupId': 'BG002'}, {'value': '6.35', 'spread': '0.743', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Vaginal pH', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) by Severity (Overall [Composite])', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '351', 'groupId': 'BG003'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}, {'value': '434', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'MBS-Vaginal Dryness at Randomization', 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '170', 'groupId': 'BG003'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '146', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Vaginal Dryness was assessed in 102, 118, and 104 subjects in the Ospemifene 30 mg, Ospemifene 60 mg, and Placebo groups, respectively.', 'unitOfMeasure': 'Participants'}, {'title': 'MBS-Vaginal Pain with Sexual Activity at Randomization', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Vaginal Pain with Sexual Activity was assessed in 136, 120, and 122 subjects in the Ospemifeme 30 mg, Ospemifene 60 mg, and Placebo groups, respectively.', 'unitOfMeasure': 'Participants'}, {'title': 'MBS-Vaginal and/or Vulvar Irritation or Itching at Randomization', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Vaginal and/or Vulvar Irritation or Itching was assessed in 39, 30, and 37 subjects in the Ospemifene 30 mg, Ospemifene 60 mg, and Placebo groups, respectively.', 'unitOfMeasure': 'Participants'}, {'title': 'MBS-Difficult/Painful Urination at Randomization', 'classes': [{'title': 'Moderate', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Difficult/Painful Urination was assessed in 3, 2, and 2 subjects in the Ospemifene 30 mg, Ospemifene 60 mg, and Placebo groups, respectively.', 'unitOfMeasure': 'Participants'}, {'title': 'MBS-Vaginal Bleeding with Sexual Activity at Randomization', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Vaginal Bleeding with Sexual Activity was assessed in 1, 5, and 0 subjects in the Ospemifene 30 mg, Ospemifene 60 mg, and Placebo groups, respectively.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 826}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-21', 'studyFirstSubmitDate': '2006-01-10', 'resultsFirstSubmitDate': '2013-03-20', 'studyFirstSubmitQcDate': '2006-01-10', 'lastUpdatePostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-21', 'studyFirstPostDateStruct': {'date': '2006-01-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom (MBS) of Vaginal Dryness', 'timeFrame': 'Baseline (Randomization) to Week 12', 'description': 'This outcome measure was analyzed using Cochran-Mantel-Haenszel (CMH) row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe'}, {'measure': 'Mean Change From Baseline in the MBS of Vaginal Pain Associated With Sexual Activity', 'timeFrame': 'Baseline (Randomization) to Week 12', 'description': 'This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe'}, {'measure': 'Mean Change From Baseline in Vaginal pH', 'timeFrame': 'Baseline (Screening) to Week 12'}, {'measure': 'Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear', 'timeFrame': 'Baseline (Screening) to Week 12'}, {'measure': 'Mean Change From Baseline in the Percentage of Superficial Cells in Maturation Index of Vaginal Smear', 'timeFrame': 'Baseline (Screening) to Week 12'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Visual Evaluation of the Vagina', 'timeFrame': 'Baseline (Screening) to Week 12', 'description': 'Exam Rating Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe'}, {'measure': 'Change From Baseline in Severity of VVA Symptoms', 'timeFrame': 'Baseline (Randomization) to Week 12', 'description': 'This outcome measure was analyzed using CMH row mean scores test controlling for study center and uterine status. VVA Symptom Score: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe'}, {'measure': 'Change From Baseline in Estradiol Levels', 'timeFrame': 'Baseline (Screening) to Week 12'}, {'measure': 'Change From Baseline in Follicle Stimulating Hormone Levels', 'timeFrame': 'Baseline (Screening) to Week 12'}, {'measure': 'Change From Baseline in Luteinizing Hormone Levels', 'timeFrame': 'Baseline (Screening) to Week 12'}, {'measure': 'Change From Baseline in Sex Hormone Binding Globulin Levels', 'timeFrame': 'Baseline (Screening) to Week 12'}, {'measure': 'Change From Baseline in Testosterone (Free) Levels', 'timeFrame': 'Baseline (Screening) to Week 12'}, {'measure': 'Change From Baseline in Testosterone (Total) Levels', 'timeFrame': 'Baseline (Screening) to Week 12'}, {'measure': 'Change From Baseline in Urinary Symptoms', 'timeFrame': 'Baseline (Randomization) to Week 12'}]}, 'conditionsModule': {'keywords': ['Urogenital atrophy', 'Vaginal atrophy', 'Vulvar and vaginal atrophy in postmenopausal women', 'Menopausal symptoms'], 'conditions': ['Atrophy', 'Vaginal Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether ospemifene is more effective than placebo in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Naturally or surgically postmenopausal\n* Moderate or severe symptoms of vaginal atrophy (ie, vaginal dryness, irritation or itching, difficult or painful urination, pain or bleeding with intercourse)\n* Vaginal pH greater than 5.0\n* 5% or fewer superficial cells in maturation index of vaginal smear\n\nExclusion Criteria:\n\n* Evidence of endometrial hyperplasia, endometrial cancer, or other abnormal endometrial pathology\n* Abnormal Pap smear\n* Uterine bleeding of unknown origin or uterine polyps\n* Current vaginal infection requiring medication'}, 'identificationModule': {'nctId': 'NCT00276094', 'briefTitle': 'A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shionogi Inc.'}, 'officialTitle': 'Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 30 and 60 Mg Daily Doses With Placebo', 'orgStudyIdInfo': {'id': '15-50310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ospemifene 30 mg/day and nonhormonal vaginal lubricant', 'description': 'Subjects will receive a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.', 'interventionNames': ['Drug: Ospemifene 30 mg', 'Drug: Nonhormonal vaginal lubricant']}, {'type': 'EXPERIMENTAL', 'label': 'Ospemifene 60 mg/day and nonhormonal vaginal lubricant', 'description': 'Subjects will receive a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.', 'interventionNames': ['Drug: Ospemifene 60 mg', 'Drug: Nonhormonal vaginal lubricant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo tablets and nonhormonal vaginal lubricant', 'description': 'Subjects will receive a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) should be applied as needed and its use should be recorded in the medication diary. The first dose of the study drug will be administered at the clinic at Visit 2.', 'interventionNames': ['Drug: Placebo', 'Drug: Nonhormonal vaginal lubricant']}], 'interventions': [{'name': 'Ospemifene 30 mg', 'type': 'DRUG', 'description': '1 tablet (dose 30 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).', 'armGroupLabels': ['Ospemifene 30 mg/day and nonhormonal vaginal lubricant']}, {'name': 'Ospemifene 60 mg', 'type': 'DRUG', 'description': '1 tablet (dose 60 mg/day) taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).', 'armGroupLabels': ['Ospemifene 60 mg/day and nonhormonal vaginal lubricant']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1 tablet taken each morning with food for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12).', 'armGroupLabels': ['Placebo tablets and nonhormonal vaginal lubricant']}, {'name': 'Nonhormonal vaginal lubricant', 'type': 'DRUG', 'otherNames': ['K-Y® Brand Jelly'], 'description': 'Subjects should apply the vaginal lubricant as needed and record the usage in the medication diary.', 'armGroupLabels': ['Ospemifene 30 mg/day and nonhormonal vaginal lubricant', 'Ospemifene 60 mg/day and nonhormonal vaginal lubricant', 'Placebo tablets and nonhormonal vaginal lubricant']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Shionogi Clinical Trials Administrator Clinical Support Help Line', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shionogi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shionogi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hormos Medical', 'class': 'INDUSTRY'}, {'name': 'QuatRx Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Shionogi Clinical Trials Administrator', 'oldOrganization': 'Shionogi'}}}}