Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT01585558
Status:
COMPLETED
Last Update Posted:
2018-05-21
First Post:
2012-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'Shionogiclintrials-admin@shionogi.co.jp', 'phone': '800-849-9707', 'title': 'Shionogi Clinical Trials Administrator', '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': '40 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks', 'otherNumAtRisk': 62, 'otherNumAffected': 9, 'seriousNumAtRisk': 62, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks', 'otherNumAtRisk': 69, 'otherNumAffected': 21, 'seriousNumAtRisk': 69, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks', 'otherNumAtRisk': 49, 'otherNumAffected': 11, 'seriousNumAtRisk': 49, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pharyngolaryngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hot Flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'seriousEvents': [{'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Encephalitis Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Meningitis Candida', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Neck Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Breast Cancer In Situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Breast Prosthesis Implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'title': 'Treatment-Emergent AE', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Related AE (Possibly/Probably/Definitely Related)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'AE Causing Study Drug Discontinuation', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Serious AE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Severe AE', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 20 (Phone Contact) to Week 56 (Visit 7)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Assessment of Cervical Pap Smear Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'title': 'ASC-US', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Inadequate squamous epithelial component', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Low grade SIL (slight dysplasia and/or HPV effect)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Negative for intraepithelial lesion or malignancy', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': 'Reactive endocervical and/or metaplastic cells', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Unsatisfactory: Due to reasons noted', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 (Visit 6)', 'description': 'Cervical Pap smear samples were used to evaluate: atypical squamous cells of undetermined significance (ASC-US), squamous intraepithelial lesions (SILs), intraepithelial lesions or malignancy, and reactive endocervical cells and/or metaplastic cells.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 34 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Assessment of Endometrial Biopsy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'title': 'Atrophic/inactive/insufficient', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Weakly proliferative', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Atypical epithelial proliferation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Proliferative pattern, disordered type', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Other (Polyp, atrophic type)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperplasia or carcinoma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 (Visit 6)', 'description': "Assessments were based on Blaustein's classification.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 46 out of 62 subjects in the ospemifene 30 mg group, 55 out of 69 subjects in the ospemifene 60 mg group, and 32 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Mean Percent Change From Baseline in Serum Lipids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'title': 'Total Cholesterol', 'categories': [{'measurements': [{'value': '-0.14', 'spread': '14.807', 'groupId': 'OG000'}, {'value': '2.35', 'spread': '13.663', 'groupId': 'OG001'}, {'value': '6.24', 'spread': '12.904', 'groupId': 'OG002'}]}]}, {'title': 'Low-density-lipoprotein cholesterol (LDL-C)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '19.462', 'groupId': 'OG000'}, {'value': '2.42', 'spread': '19.107', 'groupId': 'OG001'}, {'value': '10.38', 'spread': '19.776', 'groupId': 'OG002'}]}]}, {'title': 'High-density-lipoprotein cholesterol (HDL-C)', 'categories': [{'measurements': [{'value': '6.48', 'spread': '13.881', 'groupId': 'OG000'}, {'value': '5.76', 'spread': '12.686', 'groupId': 'OG001'}, {'value': '2.39', 'spread': '14.026', 'groupId': 'OG002'}]}]}, {'title': 'Triglycerides', 'categories': [{'measurements': [{'value': '-0.66', 'spread': '28.864', 'groupId': 'OG000'}, {'value': '5.12', 'spread': '31.076', 'groupId': 'OG001'}, {'value': '20.36', 'spread': '41.755', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Percent Change From Baseline in Serum Lipids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'title': 'Total Cholesterol', 'categories': [{'measurements': [{'value': '-0.55', 'spread': '13.910', 'groupId': 'OG000'}, {'value': '-2.45', 'spread': '12.323', 'groupId': 'OG001'}, {'value': '-1.05', 'spread': '9.289', 'groupId': 'OG002'}]}]}, {'title': 'LDL-C', 'categories': [{'measurements': [{'value': '-0.87', 'spread': '19.748', 'groupId': 'OG000'}, {'value': '-6.20', 'spread': '18.623', 'groupId': 'OG001'}, {'value': '-0.42', 'spread': '15.418', 'groupId': 'OG002'}]}]}, {'title': 'HDL-C', 'categories': [{'measurements': [{'value': '6.07', 'spread': '16.836', 'groupId': 'OG000'}, {'value': '1.29', 'spread': '12.787', 'groupId': 'OG001'}, {'value': '-4.41', 'spread': '14.347', 'groupId': 'OG002'}]}]}, {'title': 'Triglycerides', 'categories': [{'measurements': [{'value': '-3.10', 'spread': '32.749', 'groupId': 'OG000'}, {'value': '15.19', 'spread': '35.789', 'groupId': 'OG001'}, {'value': '21.57', 'spread': '40.802', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Change in Blood Chemistry Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'title': 'Alanine Aminotransferase (ALT)', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '9.39', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '8.73', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '8.22', 'groupId': 'OG002'}]}]}, {'title': 'Aspartate Aminotransferase (AST)', 'categories': [{'measurements': [{'value': '0.8', 'spread': '4.67', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '5.43', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '4.59', 'groupId': 'OG002'}]}]}, {'title': 'Creatine Kinase (CK)', 'categories': [{'measurements': [{'value': '1.1', 'spread': '50.97', 'groupId': 'OG000'}, {'value': '-4.4', 'spread': '48.78', 'groupId': 'OG001'}, {'value': '18.7', 'spread': '69.50', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Change in Blood Chemistry Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'title': 'ALT', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '10.27', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '7.91', 'groupId': 'OG001'}, {'value': '-2.2', 'spread': '7.21', 'groupId': 'OG002'}]}]}, {'title': 'AST', 'categories': [{'measurements': [{'value': '1.5', 'spread': '4.99', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '5.03', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '4.95', 'groupId': 'OG002'}]}]}, {'title': 'CK', 'categories': [{'measurements': [{'value': '7.3', 'spread': '62.70', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '56.78', 'groupId': 'OG001'}, {'value': '-6.0', 'spread': '31.82', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.580', 'spread': '1.9041', 'groupId': 'OG000'}, {'value': '0.818', 'spread': '1.6689', 'groupId': 'OG001'}, {'value': '-0.119', 'spread': '1.1629', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'description': 'Mean change in endometrial thickness from baseline', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 50 out of 62 subjects in the ospemifene 30 mg group, 60 out of 69 subjects in the ospemifene 60 mg group, and 37 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Assessment of Endometrial Safety With a TVU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.681', 'spread': '2.5666', 'groupId': 'OG000'}, {'value': '1.139', 'spread': '1.5568', 'groupId': 'OG001'}, {'value': '-0.041', 'spread': '1.1455', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'description': 'Mean change in endometrial thickness from baseline', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 46 out of 62 subjects in the ospemifene 30 mg group, 52 out of 69 subjects in the ospemifene 60 mg group, and 30 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Visual Evaluation of the Vagina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'title': 'Petechiae', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.79', 'groupId': 'OG002'}]}]}, {'title': 'Pallor', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '1.02', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.94', 'groupId': 'OG002'}]}]}, {'title': 'Friability', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.95', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '0.99', 'groupId': 'OG002'}]}]}, {'title': 'Vaginal Dryness in Mucosa', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '0.91', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '1.11', 'groupId': 'OG002'}]}]}, {'title': 'Vaginal Redness in Mucosa', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.95', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '0.89', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'description': 'Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 65 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Visual Evaluation of the Vagina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'title': 'Petechiae', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.91', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '0.73', 'groupId': 'OG002'}]}]}, {'title': 'Pallor', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '1.03', 'groupId': 'OG002'}]}]}, {'title': 'Friability', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.95', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.92', 'groupId': 'OG002'}]}]}, {'title': 'Vaginal Dryness in Mucosa', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.06', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '1.02', 'groupId': 'OG002'}]}]}, {'title': 'Vaginal Redness in Mucosa', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.03', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '1.07', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'description': 'Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Estradiol (E2) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.75', 'spread': '3.27', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '5.97', 'groupId': 'OG001'}, {'value': '0.15', 'spread': '0.79', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Luteinizing Hormone (LH) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.02', 'spread': '5.26', 'groupId': 'OG000'}, {'value': '-2.86', 'spread': '6.97', 'groupId': 'OG001'}, {'value': '-0.83', 'spread': '4.82', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Follicle Stimulating Hormone (FSH) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.44', 'spread': '11.78', 'groupId': 'OG000'}, {'value': '-9.87', 'spread': '14.00', 'groupId': 'OG001'}, {'value': '-4.10', 'spread': '11.37', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '11.71', 'spread': '19.64', 'groupId': 'OG000'}, {'value': '22.64', 'spread': '28.07', 'groupId': 'OG001'}, {'value': '-2.74', 'spread': '12.84', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Testosterone (Total) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.61', 'spread': '5.29', 'groupId': 'OG000'}, {'value': '2.59', 'spread': '5.75', 'groupId': 'OG001'}, {'value': '-0.76', 'spread': '7.18', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Testosterone (Free) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.15', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in E2 Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '1.05', 'groupId': 'OG001'}, {'value': '0.14', 'spread': '0.69', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in LH Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.65', 'spread': '6.73', 'groupId': 'OG000'}, {'value': '-4.95', 'spread': '7.59', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '5.45', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in FSH Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.39', 'spread': '16.88', 'groupId': 'OG000'}, {'value': '-15.60', 'spread': '13.32', 'groupId': 'OG001'}, {'value': '-6.29', 'spread': '17.39', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in SHBG Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '11.94', 'spread': '20.81', 'groupId': 'OG000'}, {'value': '28.09', 'spread': '25.62', 'groupId': 'OG001'}, {'value': '-5.94', 'spread': '13.33', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Assessment of Mammography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'title': 'Breast cyst', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Breast mass', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Breast microcalcification', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Mammogram abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 (Visit 6)', 'description': 'Mammography was done for the detection of characteristic masses and microcalcifications in the breast.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Testosterone (Total) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.92', 'spread': '5.13', 'groupId': 'OG000'}, {'value': '3.48', 'spread': '7.86', 'groupId': 'OG001'}, {'value': '-0.95', 'spread': '4.60', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Testosterone (Free) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.12', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Antithrombin Antigen, P Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '10.15', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '11.23', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '10.49', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Fibrinogen Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-29.1', 'spread': '83.18', 'groupId': 'OG000'}, {'value': '-25.9', 'spread': '63.17', 'groupId': 'OG001'}, {'value': '12.1', 'spread': '70.52', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Protein C Ag, P Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '20.20', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '20.68', 'groupId': 'OG001'}, {'value': '14.2', 'spread': '21.96', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Protein S Ag (Free), P Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '13.33', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '12.82', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '9.79', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Thromboplastin Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '7.48', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '3.37', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '2.87', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': 's', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Antithrombin Antigen, P Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '9.56', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '9.28', 'groupId': 'OG001'}, {'value': '7.1', 'spread': '11.64', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Fibrinogen Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.0', 'spread': '61.79', 'groupId': 'OG000'}, {'value': '-36.0', 'spread': '67.82', 'groupId': 'OG001'}, {'value': '7.4', 'spread': '96.67', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Protein C Ag, P Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '17.11', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '19.20', 'groupId': 'OG001'}, {'value': '10.6', 'spread': '20.11', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Protein S Ag (Free), P Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '16.77', 'groupId': 'OG000'}, {'value': '11.1', 'spread': '13.78', 'groupId': 'OG001'}, {'value': '9.3', 'spread': '15.92', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Thromboplastin Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '4.13', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '3.43', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '5.05', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': 's', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Assessment of Breast Palpation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'title': 'Not done', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Normal', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}, {'title': 'Abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26 (Visit 5)', 'description': 'Breast palpation was done by the investigator to assess abnormalities in the breast.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 65 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Assessment of Breast Palpation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': 'Abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 (Visit 6)', 'description': 'Breast palpation was done by the investigator to assess abnormalities in the breast.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Assessment of Hematology Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'title': 'Leukocytes (WBC)', 'categories': [{'measurements': [{'value': '-0.008', 'spread': '1.2147', 'groupId': 'OG000'}, {'value': '-0.211', 'spread': '1.3608', 'groupId': 'OG001'}, {'value': '0.207', 'spread': '1.0489', 'groupId': 'OG002'}]}]}, {'title': 'Basophils', 'categories': [{'measurements': [{'value': '0.006', 'spread': '0.0240', 'groupId': 'OG000'}, {'value': '0.001', 'spread': '0.0215', 'groupId': 'OG001'}, {'value': '-0.005', 'spread': '0.0186', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes', 'categories': [{'measurements': [{'value': '-0.035', 'spread': '0.3169', 'groupId': 'OG000'}, {'value': '-0.064', 'spread': '0.4004', 'groupId': 'OG001'}, {'value': '0.116', 'spread': '0.4972', 'groupId': 'OG002'}]}]}, {'title': 'Monocytes', 'categories': [{'measurements': [{'value': '0.025', 'spread': '0.1297', 'groupId': 'OG000'}, {'value': '-0.042', 'spread': '0.1127', 'groupId': 'OG001'}, {'value': '0.009', 'spread': '0.1362', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils', 'categories': [{'measurements': [{'value': '-0.010', 'spread': '0.9812', 'groupId': 'OG000'}, {'value': '-0.094', 'spread': '1.2380', 'groupId': 'OG001'}, {'value': '0.083', 'spread': '0.7953', 'groupId': 'OG002'}]}]}, {'title': 'Eosinophils', 'categories': [{'measurements': [{'value': '-0.010', 'spread': '0.0955', 'groupId': 'OG000'}, {'value': '-0.009', 'spread': '0.1072', 'groupId': 'OG001'}, {'value': '0.002', 'spread': '0.1168', 'groupId': 'OG002'}]}]}, {'title': 'Platelet Count', 'categories': [{'measurements': [{'value': '-5.2', 'spread': '31.23', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '30.53', 'groupId': 'OG001'}, {'value': '-4.5', 'spread': '31.56', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'description': 'Change from baseline', 'unitOfMeasure': '(x10(9)/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Erythrocyte (RBC) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.081', 'spread': '0.2232', 'groupId': 'OG000'}, {'value': '-0.089', 'spread': '0.2500', 'groupId': 'OG001'}, {'value': '0.026', 'spread': '0.2240', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': '(x10(12)/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Hemogobin Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.150', 'spread': '0.6664', 'groupId': 'OG000'}, {'value': '-0.165', 'spread': '0.6668', 'groupId': 'OG001'}, {'value': '0.140', 'spread': '0.6247', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Hematocrit Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.435', 'spread': '2.0189', 'groupId': 'OG000'}, {'value': '-0.529', 'spread': '2.1667', 'groupId': 'OG001'}, {'value': '0.398', 'spread': '1.9951', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Assessment of Hematology Test Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'title': 'Leukocytes (WBC)', 'categories': [{'measurements': [{'value': '0.061', 'spread': '1.7480', 'groupId': 'OG000'}, {'value': '-0.217', 'spread': '0.9597', 'groupId': 'OG001'}, {'value': '0.371', 'spread': '1.3680', 'groupId': 'OG002'}]}]}, {'title': 'Basophils', 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.0181', 'groupId': 'OG000'}, {'value': '0.002', 'spread': '0.0281', 'groupId': 'OG001'}, {'value': '-0.003', 'spread': '0.0214', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes', 'categories': [{'measurements': [{'value': '-0.120', 'spread': '0.4796', 'groupId': 'OG000'}, {'value': '0.001', 'spread': '0.3339', 'groupId': 'OG001'}, {'value': '-0.028', 'spread': '0.3352', 'groupId': 'OG002'}]}]}, {'title': 'Monocytes', 'categories': [{'measurements': [{'value': '-0.024', 'spread': '0.1065', 'groupId': 'OG000'}, {'value': '-0.028', 'spread': '0.1017', 'groupId': 'OG001'}, {'value': '0.021', 'spread': '0.1216', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils', 'categories': [{'measurements': [{'value': '0.194', 'spread': '1.7491', 'groupId': 'OG000'}, {'value': '-0.258', 'spread': '0.9189', 'groupId': 'OG001'}, {'value': '0.377', 'spread': '1.3568', 'groupId': 'OG002'}]}]}, {'title': 'Eosinophils', 'categories': [{'measurements': [{'value': '-0.003', 'spread': '0.1029', 'groupId': 'OG000'}, {'value': '-0.005', 'spread': '0.0823', 'groupId': 'OG001'}, {'value': '0.021', 'spread': '0.1889', 'groupId': 'OG002'}]}]}, {'title': 'Platelet Count', 'categories': [{'measurements': [{'value': '-11.2', 'spread': '34.86', 'groupId': 'OG000'}, {'value': '-16.4', 'spread': '27.80', 'groupId': 'OG001'}, {'value': '-11.3', 'spread': '37.75', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'description': 'Change from baseline', 'unitOfMeasure': '(x10(9)/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Erythrocyte (RBC) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.087', 'spread': '0.2115', 'groupId': 'OG000'}, {'value': '-0.155', 'spread': '0.2113', 'groupId': 'OG001'}, {'value': '0.028', 'spread': '0.2350', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': '(x10(12)/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Hemoglobin Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.141', 'spread': '0.6261', 'groupId': 'OG000'}, {'value': '-0.431', 'spread': '0.6367', 'groupId': 'OG001'}, {'value': '0.094', 'spread': '0.6121', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseine to Week 52 (Visit 6)', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Hematocrit Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.445', 'spread': '1.9207', 'groupId': 'OG000'}, {'value': '-1.152', 'spread': '1.9113', 'groupId': 'OG001'}, {'value': '0.174', 'spread': '2.0823', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in pH of Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.97', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '1.15', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 64 subjects in the ospemifene 30 mg group, 64 out of 69 subjects in the ospemifene 60 mg group, and 41 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Specific Gravtiy of Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.002', 'spread': '0.0074', 'groupId': 'OG000'}, {'value': '-0.003', 'spread': '0.0062', 'groupId': 'OG001'}, {'value': '-0.000', 'spread': '0.0065', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': 'units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 64 subjects in the ospemifene 30 mg group, 64 out of 69 subjects in the ospemifene 60 mg group, and 41 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in pH of Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '1.20', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 57 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Specific Gravity of Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.001', 'spread': '0.0061', 'groupId': 'OG000'}, {'value': '-0.002', 'spread': '0.0074', 'groupId': 'OG001'}, {'value': '-0.001', 'spread': '0.0067', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': 'units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 57 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Systolic Blood Pressure (SBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'spread': '15.33', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '12.16', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '11.16', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Diastolic Blood Pressure (DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '9.49', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '8.29', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '8.07', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '11.71', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '10.61', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '8.60', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.88', 'spread': '3.902', 'groupId': 'OG000'}, {'value': '0.66', 'spread': '2.997', 'groupId': 'OG001'}, {'value': '0.78', 'spread': '2.732', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.331', 'spread': '1.4659', 'groupId': 'OG000'}, {'value': '0.253', 'spread': '1.1244', 'groupId': 'OG001'}, {'value': '0.293', 'spread': '1.0131', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.5', 'spread': '15.28', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '15.30', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '15.21', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'spread': '10.32', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '9.97', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '7.85', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '9.78', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '12.05', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '6.61', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.99', 'spread': '4.975', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '3.055', 'groupId': 'OG001'}, {'value': '1.99', 'spread': '3.084', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.379', 'spread': '1.8594', 'groupId': 'OG000'}, {'value': '0.376', 'spread': '1.1942', 'groupId': 'OG001'}, {'value': '0.748', 'spread': '1.1672', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'FG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Ospemifene 30 mg (Dose 1)', 'description': 'Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'BG001', 'title': 'Ospemifene 60 mg (Dose 2)', 'description': 'Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.4', 'spread': '6.13', 'groupId': 'BG000'}, {'value': '57.7', 'spread': '5.88', 'groupId': 'BG001'}, {'value': '58.2', 'spread': '4.02', 'groupId': 'BG002'}, {'value': '58.1', 'spread': '5.51', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '180', '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': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '174', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', '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': 'White', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', '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': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Missing value', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '162.83', 'spread': '6.930', 'groupId': 'BG000'}, {'value': '162.53', 'spread': '6.488', 'groupId': 'BG001'}, {'value': '163.27', 'spread': '6.082', 'groupId': 'BG002'}, {'value': '162.84', 'spread': '6.509', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '68.92', 'spread': '11.316', 'groupId': 'BG000'}, {'value': '65.52', 'spread': '11.626', 'groupId': 'BG001'}, {'value': '66.71', 'spread': '10.482', 'groupId': 'BG002'}, {'value': '67.02', 'spread': '11.252', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.014', 'spread': '4.1507', 'groupId': 'BG000'}, {'value': '24.792', 'spread': '4.1292', 'groupId': 'BG001'}, {'value': '25.045', 'spread': '3.8496', 'groupId': 'BG002'}, {'value': '25.282', 'spread': '4.0762', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2008-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-19', 'studyFirstSubmitDate': '2012-04-18', 'resultsFirstSubmitDate': '2013-03-20', 'studyFirstSubmitQcDate': '2012-04-23', 'lastUpdatePostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-05-21', 'studyFirstPostDateStruct': {'date': '2012-04-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'Week 20 (Phone Contact) to Week 56 (Visit 7)'}, {'measure': 'Assessment of Cervical Pap Smear Samples', 'timeFrame': 'Week 52 (Visit 6)', 'description': 'Cervical Pap smear samples were used to evaluate: atypical squamous cells of undetermined significance (ASC-US), squamous intraepithelial lesions (SILs), intraepithelial lesions or malignancy, and reactive endocervical cells and/or metaplastic cells.'}, {'measure': 'Assessment of Endometrial Biopsy', 'timeFrame': 'Week 52 (Visit 6)', 'description': "Assessments were based on Blaustein's classification."}, {'measure': 'Mean Percent Change From Baseline in Serum Lipids', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Mean Percent Change From Baseline in Serum Lipids', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}, {'measure': 'Mean Change in Blood Chemistry Parameters', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Mean Change in Blood Chemistry Parameters', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}, {'measure': 'Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU)', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'description': 'Mean change in endometrial thickness from baseline'}, {'measure': 'Assessment of Endometrial Safety With a TVU', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'description': 'Mean change in endometrial thickness from baseline'}, {'measure': 'Change From Baseline in Visual Evaluation of the Vagina', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'description': 'Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).'}, {'measure': 'Change From Baseline in Visual Evaluation of the Vagina', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'description': 'Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).'}, {'measure': 'Change From Baseline in Estradiol (E2) Levels', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Change From Baseline in Luteinizing Hormone (LH) Levels', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Change From Baseline in Follicle Stimulating Hormone (FSH) Levels', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Change From Baseline in Testosterone (Total) Levels', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Change From Baseline in Testosterone (Free) Levels', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Change From Baseline in E2 Levels', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}, {'measure': 'Change From Baseline in LH Levels', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}, {'measure': 'Change From Baseline in FSH Levels', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}, {'measure': 'Change From Baseline in SHBG Levels', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}, {'measure': 'Assessment of Mammography', 'timeFrame': 'Week 52 (Visit 6)', 'description': 'Mammography was done for the detection of characteristic masses and microcalcifications in the breast.'}, {'measure': 'Change From Baseline in Testosterone (Total) Levels', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}, {'measure': 'Change From Baseline in Testosterone (Free) Levels', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}, {'measure': 'Change From Baseline in Antithrombin Antigen, P Levels', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Change From Baseline in Fibrinogen Levels', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Change From Baseline in Protein C Ag, P Levels', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Change From Baseline in Protein S Ag (Free), P Levels', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Change From Baseline in Thromboplastin Time', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Change From Baseline in Antithrombin Antigen, P Levels', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}, {'measure': 'Change From Baseline in Fibrinogen Levels', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}, {'measure': 'Change From Baseline in Protein C Ag, P Levels', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}, {'measure': 'Change From Baseline in Protein S Ag (Free), P Levels', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}, {'measure': 'Change From Baseline in Thromboplastin Time', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}, {'measure': 'Assessment of Breast Palpation', 'timeFrame': 'Week 26 (Visit 5)', 'description': 'Breast palpation was done by the investigator to assess abnormalities in the breast.'}, {'measure': 'Assessment of Breast Palpation', 'timeFrame': 'Week 52 (Visit 6)', 'description': 'Breast palpation was done by the investigator to assess abnormalities in the breast.'}, {'measure': 'Assessment of Hematology Tests', 'timeFrame': 'Baseline to Week 26 (Visit 5)', 'description': 'Change from baseline'}, {'measure': 'Change From Baseline in Erythrocyte (RBC) Levels', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Change From Baseline in Hemogobin Levels', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Change From Baseline in Hematocrit Levels', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Assessment of Hematology Test Values', 'timeFrame': 'Baseline to Week 52 (Visit 6)', 'description': 'Change from baseline'}, {'measure': 'Change From Baseline in Erythrocyte (RBC) Levels', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}, {'measure': 'Change From Baseline in Hemoglobin Levels', 'timeFrame': 'Baseine to Week 52 (Visit 6)'}, {'measure': 'Change From Baseline in Hematocrit Levels', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}, {'measure': 'Change From Baseline in pH of Urine', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Change From Baseline in Specific Gravtiy of Urine', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Change From Baseline in pH of Urine', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}, {'measure': 'Change From Baseline in Specific Gravity of Urine', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}, {'measure': 'Change From Baseline in Systolic Blood Pressure (SBP)', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Change From Baseline in Diastolic Blood Pressure (DBP)', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Change From Baseline in Pulse Rate', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Change From Baseline in Weight', 'timeFrame': 'Baseline to Week 26 (Visit 5)'}, {'measure': 'Change From Baseline in BMI', 'timeFrame': 'Baseline to Week 26'}, {'measure': 'Change From Baseline in SBP', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}, {'measure': 'Change From Baseline in DBP', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}, {'measure': 'Change From Baseline in Pulse Rate', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}, {'measure': 'Change From Baseline in Weight', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}, {'measure': 'Change From Baseline in BMI', 'timeFrame': 'Baseline to Week 52 (Visit 6)'}]}, 'conditionsModule': {'keywords': ['Menopausal symptoms', 'Urogenital atrophy', 'Vulvar and vaginal atrophy in menopausal women', 'Vaginal atrophy'], 'conditions': ['Atrophy', 'Vaginal Diseases']}, 'referencesModule': {'references': [{'pmid': '37619252', 'type': 'DERIVED', 'citation': 'Lara LA, Cartagena-Ramos D, Figueiredo JB, Rosa-E-Silva ACJ, Ferriani RA, Martins WP, Fuentealba-Torres M. Hormone therapy for sexual function in perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2023 Aug 24;8(8):CD009672. doi: 10.1002/14651858.CD009672.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal women with an intact uterus.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Postmenopausal women aged 40 to 80 years with a diagnosis of vulvar and vaginal atrophy (VVA) as assessed by vaginal pH, maturation index of vaginal smear, and self-reported symptoms at Baseline for Protocol 15-50310\n* Had an intact uterus\n* Met the inclusion and exclusion criteria for Protocol 15-50310\n* Had completed Protocol 15-50310\n\nExclusion Criteria:\n\n* Had clinically significant abnormal findings at the Week 12 End of Study visit for Protocol 15-50310\n* Had any physical or mental condition which, in the opinion of the investigator, may have interfered with the subject's ability to comply with the study procedures"}, 'identificationModule': {'nctId': 'NCT01585558', 'briefTitle': 'Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shionogi Inc.'}, 'officialTitle': 'Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus: A 40 Week Randomized, Double Blind, Placebo Controlled, Follow-Up to Protocol 15-50310.', 'orgStudyIdInfo': {'id': '15-50310X'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group 1', 'interventionNames': ['Drug: Ospemifene (Dose 1)']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Group 2', 'interventionNames': ['Drug: Ospemifene (Dose 2)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment Group 3', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ospemifene (Dose 1)', 'type': 'DRUG', 'armGroupLabels': ['Treatment Group 1']}, {'name': 'Ospemifene (Dose 2)', 'type': 'DRUG', 'armGroupLabels': ['Treatment Group 2']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Treatment Group 3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Shionogi Clinical Trials Administrator Clinical Support Help Line', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shionogi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shionogi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'QuatRx Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}