Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT01389102
Status:
COMPLETED
Last Update Posted:
2012-06-11
First Post:
2011-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019584', 'term': 'Hot Flashes'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jjoffrion@kvph.com', 'phone': '314-645-6600', 'title': 'Jim Joffrion', 'phoneExt': '3410', 'organization': 'KV Pharmaceutical Company'}, 'certainAgreement': {'otherDetails': 'Investigator shall not publish, or seek to publish, either in whole or in part, any results of the Clinical Investigation without the written consent of the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'Adverse Events will be collected and assessed during each study visit during the 12 week treatment period and any ongoing events will be followed until resolution or stabilization.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Transdermal Three 90 μL Sprays', 'description': 'Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator', 'otherNumAtRisk': 75, 'otherNumAffected': 13, 'seriousNumAtRisk': 75, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Transdermal Two 90 μL Sprays', 'description': 'Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator', 'otherNumAtRisk': 76, 'otherNumAffected': 18, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo Transdermal One 90 μL Spray', 'description': 'Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator', 'otherNumAtRisk': 77, 'otherNumAffected': 12, 'seriousNumAtRisk': 77, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Estradiol Transdermal Three 90 μL Sprays', 'description': 'Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator', 'otherNumAtRisk': 76, 'otherNumAffected': 21, 'seriousNumAtRisk': 76, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Estradiol Transdermal Two 90 μL Sprays', 'description': 'Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator', 'otherNumAtRisk': 74, 'otherNumAffected': 29, 'seriousNumAtRisk': 74, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Estradiol Transdermal One 90 μL Spray', 'description': 'Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator', 'otherNumAtRisk': 76, 'otherNumAffected': 21, 'seriousNumAtRisk': 76, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 76, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 76, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Breast Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 76, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Nipple Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}], 'seriousEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Uterine Prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Impaired Gastric Emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Spinal Column Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Chronic Obstructive Airways Disease Excerbated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}, {'value': '74', 'groupId': 'OG004'}, {'value': '76', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Transdermal Three 90 μL Sprays'}, {'id': 'OG001', 'title': 'Placebo Transdermal Two 90 μL Sprays'}, {'id': 'OG002', 'title': 'Placebo Transdermal One 90 μL Spray'}, {'id': 'OG003', 'title': 'Estradiol Transdermal Three 90 μL Sprays'}, {'id': 'OG004', 'title': 'Estradiol Transdermal Two 90 μL Sprays'}, {'id': 'OG005', 'title': 'Estradiol Transdermal One 90 μL Spray'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.32', 'spread': '6.30', 'groupId': 'OG000'}, {'value': '-6.19', 'spread': '5.77', 'groupId': 'OG001'}, {'value': '-4.76', 'spread': '5.84', 'groupId': 'OG002'}, {'value': '-8.44', 'spread': '4.50', 'groupId': 'OG003'}, {'value': '-8.66', 'spread': '6.65', 'groupId': 'OG004'}, {'value': '-8.10', 'spread': '4.02', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0099', 'groupIds': ['OG001', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0004', 'groupIds': ['OG005'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline to week 12', 'description': 'Patients completed a daily diary to record the number of mild, moderate and number of moderate or severe vasomotor symptoms \\[hot flushes and sweating\\] experienced each day.\n\nMild, moderate and severe hot flushes and sweating were defined as follows:\n\nMild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity', 'unitOfMeasure': 'Vasomotor symptoms per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Change the Severity of Moderate to Severe Vasomotor Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}, {'value': '74', 'groupId': 'OG004'}, {'value': '76', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Transdermal Three 90 μL Sprays', 'description': 'Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator'}, {'id': 'OG001', 'title': 'Placebo Transdermal Two 90 μL Sprays', 'description': 'Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator'}, {'id': 'OG002', 'title': 'Placebo Transdermal One 90 μL Spray', 'description': 'Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator'}, {'id': 'OG003', 'title': 'Estradiol Transdermal Three 90 μL Sprays', 'description': 'Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator'}, {'id': 'OG004', 'title': 'Estradiol Transdermal Two 90 μL Sprays', 'description': 'Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator'}, {'id': 'OG005', 'title': 'Estradiol Transdermal One 90 μL Spray', 'description': 'Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.31', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '-0.26', 'spread': '0.60', 'groupId': 'OG002'}, {'value': '-1.07', 'spread': '1.01', 'groupId': 'OG003'}, {'value': '-0.92', 'spread': '1.01', 'groupId': 'OG004'}, {'value': '-1.04', 'spread': '1.01', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0406', 'groupIds': ['OG001', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG005'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline to week 12 (12 weeks)', 'description': 'Patients completed a daily diary to record the number of mild, moderate and severe vasomotor symptoms experienced each day.\n\nMild, moderate and severe were defined as follows:\n\nMild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity Severity of hot flushes was measured on a scale of none = 0, mild = 1, moderate = 2 and severe = 3.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Transdermal Three 90 μL Sprays', 'description': 'Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator'}, {'id': 'FG001', 'title': 'Placebo Transdermal Two 90 μL Sprays', 'description': 'Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator'}, {'id': 'FG002', 'title': 'Placebo Transdermal One 90 μL Spray', 'description': 'Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator'}, {'id': 'FG003', 'title': 'Estradiol Transdermal Three 90 μL Sprays', 'description': 'Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator'}, {'id': 'FG004', 'title': 'Estradiol Transdermal Two 90 μL Sprays', 'description': 'Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator'}, {'id': 'FG005', 'title': 'Estradiol Transdermal One 90 μL Spray', 'description': 'Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '76'}, {'groupId': 'FG002', 'numSubjects': '77'}, {'groupId': 'FG003', 'numSubjects': '76'}, {'groupId': 'FG004', 'numSubjects': '74'}, {'groupId': 'FG005', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '58'}, {'groupId': 'FG003', 'numSubjects': '69'}, {'groupId': 'FG004', 'numSubjects': '61'}, {'groupId': 'FG005', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Hurricane Katrina', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Subject Traveling Out of Country', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Subject Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': "Unavailable due to husband's illness", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Investigator Judgement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Participants were recruited from 43 physicians' offices, or their affiliated locations, within the United States between 17 December 2004 and 09 March 2006", 'preAssignmentDetails': 'Participants underwent a four week screening period to determine eligibility prior to assignment into the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}, {'value': '76', 'groupId': 'BG005'}, {'value': '454', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Transdermal Three 90 μL Sprays', 'description': 'Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator'}, {'id': 'BG001', 'title': 'Placebo Transdermal Two 90 μL Sprays', 'description': 'Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator'}, {'id': 'BG002', 'title': 'Placebo Transdermal One 90 μL Spray', 'description': 'Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator'}, {'id': 'BG003', 'title': 'Estradiol Transdermal Three 90 μL Sprays', 'description': 'Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator'}, {'id': 'BG004', 'title': 'Estradiol Transdermal Two 90 μL Sprays', 'description': 'Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator'}, {'id': 'BG005', 'title': 'Estradiol Transdermal One 90 μL Spray', 'description': 'Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.0', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '52.0', 'spread': '7.0', 'groupId': 'BG001'}, {'value': '52.8', 'spread': '6.9', 'groupId': 'BG002'}, {'value': '52.3', 'spread': '5.7', 'groupId': 'BG003'}, {'value': '52.2', 'spread': '6.8', 'groupId': 'BG004'}, {'value': '53.5', 'spread': '6.8', 'groupId': 'BG005'}, {'value': '52.7', 'spread': '6.5', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}, {'value': '76', 'groupId': 'BG005'}, {'value': '454', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 454}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-08', 'studyFirstSubmitDate': '2011-07-05', 'resultsFirstSubmitDate': '2012-02-29', 'studyFirstSubmitQcDate': '2011-07-06', 'lastUpdatePostDateStruct': {'date': '2012-06-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-08', 'studyFirstPostDateStruct': {'date': '2011-07-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day', 'timeFrame': 'baseline to week 12', 'description': 'Patients completed a daily diary to record the number of mild, moderate and number of moderate or severe vasomotor symptoms \\[hot flushes and sweating\\] experienced each day.\n\nMild, moderate and severe hot flushes and sweating were defined as follows:\n\nMild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity'}, {'measure': 'Mean Change the Severity of Moderate to Severe Vasomotor Symptoms', 'timeFrame': 'baseline to week 12 (12 weeks)', 'description': 'Patients completed a daily diary to record the number of mild, moderate and severe vasomotor symptoms experienced each day.\n\nMild, moderate and severe were defined as follows:\n\nMild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity Severity of hot flushes was measured on a scale of none = 0, mild = 1, moderate = 2 and severe = 3.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Postmenopause', 'Hot Flashes', 'Estradiol', 'Polyestradiol phosphate', 'Estradiol valerate', 'Estradiol 3-benzoate', 'Estradiol 17 beta-cypionate', 'Estrogens', 'Hormones', 'Hormones, Hormone Substitutes', 'Hormone Antagonists'], 'conditions': ['Hot Flashes']}, 'referencesModule': {'references': [{'pmid': '18515518', 'type': 'DERIVED', 'citation': 'Buster JE, Koltun WD, Pascual ML, Day WW, Peterson C. Low-dose estradiol spray to treat vasomotor symptoms: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1343-51. doi: 10.1097/AOG.0b013e318175d162.'}]}, 'descriptionModule': {'briefSummary': 'Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in postmenopausal women. This study will evaluate the safety and efficacy of Evamist.', 'detailedDescription': 'Multicenter, randomized, double-blind, placebo-controlled trial evaluating different doses of transdermal estradiol delivered by sray to symptomatic postmenopausal women. The endpoints are the reduction in frequency and severity of hot flushes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post menopausal women,\n* Ages 35 or older,\n* Frequent moderate to severe hot flushes,\n* Qualifying general medical health\n\nExclusion Criteria:\n\n* Disqualifying gynecological disorders,\n* Disqualifying dermatological disorders,\n* Disqualifying concurrent conditions'}, 'identificationModule': {'nctId': 'NCT01389102', 'briefTitle': 'Estradiol Transdermal Spray in the Treatment of Vasomotor Symptoms', 'nctIdAliases': ['NCT00122200'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Lumara Health, Inc.'}, 'officialTitle': 'A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Estradiol Metered-Dose Transdermal Spray (MDTS) in the Treatment of Vasomotor Symptoms in Postmenopausal Women', 'orgStudyIdInfo': {'id': 'EST-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo transdermal three 90 μL sprays', 'description': 'Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator', 'interventionNames': ['Drug: Placebo transdermal three 90 μL sprays']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo transdermal two 90 μL sprays', 'description': 'Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator', 'interventionNames': ['Drug: Placebo transdermal two 90 μL sprays']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo transdermal one 90 μL spray', 'description': 'Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator', 'interventionNames': ['Drug: Placebo transdermal one 90 μL spray']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Estradiol transdermal three 90 μL sprays', 'description': 'Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator', 'interventionNames': ['Drug: Estradiol transdermal three 90 μL sprays']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Estradiol transdermal two 90 μL sprays', 'description': 'Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator', 'interventionNames': ['Drug: Estradiol transdermal spray, two 90 μL sprays']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Estradiol transdermal one 90 μL spray', 'description': 'Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator', 'interventionNames': ['Drug: Estradiol transdermal one 90 μL spray']}], 'interventions': [{'name': 'Estradiol transdermal one 90 μL spray', 'type': 'DRUG', 'description': 'Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator', 'armGroupLabels': ['Estradiol transdermal one 90 μL spray']}, {'name': 'Estradiol transdermal spray, two 90 μL sprays', 'type': 'DRUG', 'description': 'Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator', 'armGroupLabels': ['Estradiol transdermal two 90 μL sprays']}, {'name': 'Estradiol transdermal three 90 μL sprays', 'type': 'DRUG', 'description': 'Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator', 'armGroupLabels': ['Estradiol transdermal three 90 μL sprays']}, {'name': 'Placebo transdermal two 90 μL sprays', 'type': 'DRUG', 'description': 'Placebo transdermal spray, two 90 μL 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'state': 'Alabama', 'country': 'United States', 'facility': 'Costal Clinical Research', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85739', 'city': 'Oro Valley', 'state': 'Arizona', 'country': 'United States', 'facility': 'Harmony Clinic', 'geoPoint': {'lat': 32.39091, 'lon': -110.96649}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Hope Research Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85701', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'NEA Womens Clinic', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72205', 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Lewis Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23507', 'city': 'Norfold', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Eastern Virginia'}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': "Tacoma Women's Specialists", 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lumara Health, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}