Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT00729469
Status:
COMPLETED
Last Update Posted:
2018-05-18
First Post:
2008-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C119141', 'term': 'Ospemifene'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shionogiclintrialsadmin@shionogi.com', 'phone': '800-849-9707', 'title': 'Shionogi Clinical Trials Administrator', 'phoneExt': '1454', 'organization': 'Shionogi Inc.'}, 'certainAgreement': {'otherDetails': "The sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '16 Weeks During the time period after the signing of the informed consent form and including the collection of the last safety information', 'eventGroups': [{'id': 'EG000', 'title': 'Subjects on Placebo', 'description': 'Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.', 'otherNumAtRisk': 456, 'otherNumAffected': 102, 'seriousNumAtRisk': 456, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Subjects on Ospemifene 60 mg/Day', 'description': 'Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.', 'otherNumAtRisk': 463, 'otherNumAffected': 153, 'seriousNumAtRisk': 463, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 37}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Vulvovaginal Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Vulvovaginal Mycotic Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Vaginal Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 21}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Hot Flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 32}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'seriousEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Autoimmune Thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Hypoparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Peridiverticular Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Lumbar Spinal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Lung Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Intracranial Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Bipolar Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Bladder Prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 456, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects on Placebo', 'description': 'Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}, {'id': 'OG001', 'title': 'Subjects on Ospemifene 60 mg/Day', 'description': 'Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.7', 'spread': '29.97', 'groupId': 'OG000'}, {'value': '-31.7', 'spread': '37.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'percentage of parabasal cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; LOCF'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects on Placebo', 'description': 'Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}, {'id': 'OG001', 'title': 'Subjects on Ospemifene 60 mg/Day', 'description': 'Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '9.02', 'groupId': 'OG000', 'lowerLimit': '-11', 'upperLimit': '57'}, {'value': '12.4', 'spread': '15.36', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '65'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'percentage of superficial cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; LOCF'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in Vaginal pH (Dryness Strata)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects on Placebo', 'description': 'Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}, {'id': 'OG001', 'title': 'Subjects on Ospemifene 60 mg/Day', 'description': 'Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.24', 'spread': '0.800', 'groupId': 'OG000'}, {'value': '-0.92', 'spread': '1.100', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; LOCF'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects on Placebo', 'description': 'Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}, {'id': 'OG001', 'title': 'Subjects on Ospemifene 60 mg/Day', 'description': 'Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.8', 'spread': '2.18', 'groupId': 'OG000'}, {'value': '-31.2', 'spread': '2.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'unitOfMeasure': 'percentage of parabasal cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects on Placebo', 'description': 'Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}, {'id': 'OG001', 'title': 'Subjects on Ospemifene 60 mg/Day', 'description': 'Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '1.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'unitOfMeasure': 'percentage of superficial cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects on Placebo', 'description': 'Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}, {'id': 'OG001', 'title': 'Subjects on Ospemifene 60 mg/Day', 'description': 'Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}], 'classes': [{'title': '-3 (Sev. to none)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': '-2 (Sev. to mild, or mod. to none)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': '-1 (Sev. to mod., mod.to mild, or mild to none)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': '0 (No change)', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': '1 (None to mild, mild to mod., or mod. to sev.)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; LOCF'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects on Placebo', 'description': 'Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}, {'id': 'OG001', 'title': 'Subjects on Ospemifene 60 mg/Day', 'description': 'Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '30.00', 'groupId': 'OG000'}, {'value': '-40.2', 'spread': '38.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'percentage of parabasal cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; LOCF'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects on Placebo', 'description': 'Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}, {'id': 'OG001', 'title': 'Subjects on Ospemifene 60 mg/Day', 'description': 'Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '6.88', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '14.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'percentage of superficial cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; LOCF'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects on Placebo', 'description': 'Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}, {'id': 'OG001', 'title': 'Subjects on Ospemifene 60 mg/Day', 'description': 'Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.814', 'groupId': 'OG000'}, {'value': '-0.94', 'spread': '1.016', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; LOCF'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects on Placebo', 'description': 'Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}, {'id': 'OG001', 'title': 'Subjects on Ospemifene 60 mg/Day', 'description': 'Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}], 'classes': [{'title': '-3 (Sev. to none)', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': '-2 (Sev. to mild, or mod. to none)', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': '-1 (Sev. to mod., mod.to mild, or mild to none)', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': '0 (No change)', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': '1 (None to mild, mild to mod., or mod. to sev.)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; LOCF'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in Vaginal pH (Dryness Strata)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects on Placebo', 'description': 'Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}, {'id': 'OG001', 'title': 'Subjects on Ospemifene 60 mg/Day', 'description': 'Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.884', 'groupId': 'OG000'}, {'value': '-0.81', 'spread': '0.962', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects on Placebo', 'description': 'Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}, {'id': 'OG001', 'title': 'Subjects on Ospemifene 60 mg/Day', 'description': 'Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}], 'classes': [{'title': '-3 (Sev. to None)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': '-2 (Sev. to Mild, or Mod. to None)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': '-1 (Sev. to Mod., Mod. to Mild, or Mild to None)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': '0 (No change)', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': '1 (None to Mild, Mild to Mod., or Mod. to Sev.)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; change from baseline to week 4 in severity of most bothersome symptom of vaginal dryness associated with sexual activity (dryness strata) was assessed in 152 subjects in the placebo group and 154 subjects in the ospemifene 60 mg/day group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects on Placebo', 'description': 'Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}, {'id': 'OG001', 'title': 'Subjects on Ospemifene 60 mg/Day', 'description': 'Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.821', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.979', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects on Placebo', 'description': 'Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}, {'id': 'OG001', 'title': 'Subjects on Ospemifene 60 mg/Day', 'description': 'Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}], 'classes': [{'title': '-3 (Sev. to None)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': '-2 (Sev. to Mild, or Mod. to None)', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}, {'title': '-1 (Sev. to Mod., Mod. to Mild, or Mild to None)', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': '0 (No change)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': '1 (None to Mild, Mild to Mod., or Mod. to Sev.)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; change from baseline to week 4 in severity of most bothersome symptom of vaginal pain associated with sexual activity (dyspareunia strata) was assessed in 287 subjects in the placebo group and 295 subjects in the ospemifene 60 mg/day group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects on Placebo', 'description': 'Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}, {'id': 'OG001', 'title': 'Subjects on Ospemifene 60 mg/Day', 'description': 'Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '-37.8', 'spread': '1.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'unitOfMeasure': 'percentage of parabasal cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects on Placebo', 'description': 'Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}, {'id': 'OG001', 'title': 'Subjects on Ospemifene 60 mg/Day', 'description': 'Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '0.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'unitOfMeasure': 'percentage of superficial cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Subjects on Placebo', 'description': 'Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}, {'id': 'FG001', 'title': 'Subjects on Ospemifene 60 mg/Day', 'description': 'Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '456'}, {'groupId': 'FG001', 'numSubjects': '463'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '403'}, {'groupId': 'FG001', 'numSubjects': '416'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Other-Not mentioned', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'First patient was screened on August 04, 2008 and last patient completed on July 30, 2009', 'preAssignmentDetails': 'Subjects reporting moderate to severe VVA symptoms of vaginal dryness or vaginal pain associated with sexual activity as the most bothersome symptom (MBS) at the initial screening visit were allowed to continue in the screening phase of the study. Each subject entered 1 of 2 strata based on their self-reported moderate to severe MBS'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '919', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Subjects on Placebo', 'description': 'Subjects received a single, oral dose (1 tablet) of placebo each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}, {'id': 'BG001', 'title': 'Subjects on Ospemifene 60 mg/Day', 'description': 'Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.5', 'spread': '6.39', 'groupId': 'BG000'}, {'value': '58.7', 'spread': '6.56', 'groupId': 'BG001'}, {'value': '58.6', 'spread': '6.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<45', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': '45-54', 'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}]}, {'title': '55-64', 'categories': [{'measurements': [{'value': '266', 'groupId': 'BG000'}, {'value': '260', 'groupId': 'BG001'}, {'value': '526', 'groupId': 'BG002'}]}]}, {'title': '>=65', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '456', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '919', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '396', 'groupId': 'BG000'}, {'value': '409', 'groupId': 'BG001'}, {'value': '805', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '162.6', 'spread': '6.39', 'groupId': 'BG000'}, {'value': '162.3', 'spread': '6.34', 'groupId': 'BG001'}, {'value': '162.5', 'spread': '6.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '69.38', 'spread': '12.38', 'groupId': 'BG000'}, {'value': '68.98', 'spread': '12.38', 'groupId': 'BG001'}, {'value': '69.18', 'spread': '12.37', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '26.21', 'spread': '4.32', 'groupId': 'BG000'}, {'value': '26.16', 'spread': '4.31', 'groupId': 'BG001'}, {'value': '26.18', 'spread': '4.31', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 919}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-19', 'studyFirstSubmitDate': '2008-08-04', 'resultsFirstSubmitDate': '2013-03-19', 'studyFirstSubmitQcDate': '2008-08-06', 'lastUpdatePostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-05-21', 'studyFirstPostDateStruct': {'date': '2008-08-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata)', 'timeFrame': '12 weeks'}, {'measure': 'Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata)', 'timeFrame': '12 weeks'}, {'measure': 'Change From Baseline to Week 12 in Vaginal pH (Dryness Strata)', 'timeFrame': '12 weeks'}, {'measure': 'Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)', 'timeFrame': '12 weeks'}, {'measure': 'Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata)', 'timeFrame': '12 weeks'}, {'measure': 'Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata)', 'timeFrame': '12 weeks'}, {'measure': 'Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata)', 'timeFrame': '12 weeks'}, {'measure': 'Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata)', 'timeFrame': '4 weeks'}, {'measure': 'Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata)', 'timeFrame': '4 weeks'}, {'measure': 'Change From Baseline to Week 4 in Vaginal pH (Dryness Strata)', 'timeFrame': '4 weeks'}, {'measure': 'Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)', 'timeFrame': '4 weeks'}, {'measure': 'Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata)', 'timeFrame': '4 weeks'}, {'measure': 'Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)', 'timeFrame': '4 weeks'}, {'measure': 'Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata)', 'timeFrame': '4 weeks'}, {'measure': 'Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata)', 'timeFrame': '4 weeks'}]}, 'conditionsModule': {'keywords': ['Vulvar and vaginal atrophy in postmenopausal women', 'Menopausal symptoms', 'Vaginal atrophy', 'Urogenital atrophy'], 'conditions': ['Atrophy', 'Vaginal Diseases']}, 'referencesModule': {'references': [{'pmid': '23361170', 'type': 'DERIVED', 'citation': 'Portman DJ, Bachmann GA, Simon JA; Ospemifene Study Group. Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause. 2013 Jun;20(6):623-30. doi: 10.1097/gme.0b013e318279ba64.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Naturally or surgically menopausal\n* Moderate or severe symptoms of vaginal atrophy\n* 5% or fewer superficial cells in maturation index of vaginal smear\n* Vaginal pH greater than 5.0\n* Self reported Most Bothersome Symptom of vaginal dryness or vaginal pain associated with sexual activity, with a severity of moderate or severe at randomization\n\nExclusion Criteria:\n\n* Uterine bleeding of unknown origin, uterine polyps or symptomatic and/or large uterine fibroids\n* Current vaginal infection requiring medication\n* Clinically significant abnormal gynecological findings other than signs of vaginal atrophy (e.g.\n\nuterine or vaginal prolapse of Grade 2 or higher)\n\n* Previous participation in any other ospemifene study'}, 'identificationModule': {'nctId': 'NCT00729469', 'briefTitle': 'Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shionogi Inc.'}, 'officialTitle': 'Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity, Symptoms of Vulvar and Vaginal Atrophy (VVA), Associated With Menopause: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Oral Ospemifene 60 mg Dose With Placebo in Postmenopausal Women', 'orgStudyIdInfo': {'id': '15-50821'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ospemifene 60 mg/day and K-Y® lubricant', 'description': 'Subjects will receive a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed.', 'interventionNames': ['Drug: Ospemifene 60 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo and K-Y® lubricant', 'description': 'Subjects will receive a single, oral dose (1 tablet) of Placebo each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ospemifene 60 mg', 'type': 'DRUG', 'otherNames': ['Osphena®'], 'description': '60 mg/day oral dose of ospemifene for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed', 'armGroupLabels': ['Ospemifene 60 mg/day and K-Y® lubricant']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral dose of placebo,1 tablet/day, for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed', 'armGroupLabels': ['Placebo and K-Y® lubricant']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shionogi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hormos Medical', 'class': 'INDUSTRY'}, {'name': 'QuatRx Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}