Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT00781456
Status:
COMPLETED
Last Update Posted:
2017-02-06
First Post:
2008-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Multicenter Study to Evaluate the Efficacy of a 91-Day Extended Cycle Oral Contraceptive for Menstrually-Related Migraine Headaches
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000606708', 'term': 'Seasonique'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ustevatrials@tevapharm.com', 'phone': '215-591-3000', 'title': 'Director, Clinical Research', 'organization': 'Teva Branded Pharmaceutical Products, R&D Inc.'}, 'certainAgreement': {'otherDetails': "Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 15 weeks', 'eventGroups': [{'id': 'EG000', 'title': '91-day Levonorgestrel Oral Contraceptive', 'description': 'Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.', 'otherNumAtRisk': 57, 'otherNumAffected': 21, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.', 'otherNumAtRisk': 49, 'otherNumAffected': 11, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 18, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '91-day Levonorgestrel Oral Contraceptive', 'description': 'Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.1', 'groupId': 'OG000'}, {'value': '48.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.954', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '0.87', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.43', 'estimateComment': '91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \\>=50% reduction in migraine frequency during the treatment period.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model with terms of treatment, weekly baseline migraine frequency, and center included in the model.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (25-35 days before Day 1) and Days 1-91', 'description': 'The number of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) through the end of the 91-day treatment period compared with Baseline (the 25- to 35-day baseline qualification period). Participants recorded the incidence, timing and intensity of migraines in a migraine diary during the prequalification period and throughout the 91-day treatment period.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the First, Second and Third Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '91-day Levonorgestrel Oral Contraceptive', 'description': 'Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.'}], 'classes': [{'title': 'First Month (N=54, 45)', 'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000'}, {'value': '37.8', 'groupId': 'OG001'}]}]}, {'title': 'Second Month (N=51, 44)', 'categories': [{'measurements': [{'value': '62.7', 'groupId': 'OG000'}, {'value': '52.3', 'groupId': 'OG001'}]}]}, {'title': 'Third Month (N=40, 37)', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}, {'value': '64.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.479', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '1.17', 'pValueComment': 'No adjustment for multiple comparisons was performed.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.44', 'estimateComment': '91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \\>=50% reduction in migraine frequency during the treatment period.', 'groupDescription': 'Comparison of percentage of participants with a reduction of 50% or more in migraine frequency during the first month of treatment.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model with terms of treatment, baseline weekly migraine frequency and center included in the model.', 'testedNonInferiority': False}, {'pValue': '0.256', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '1.37', 'pValueComment': 'No adjustment for multiple comparisons was performed.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.44', 'estimateComment': '91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \\>=50% reduction in migraine frequency during the treatment period.', 'groupDescription': 'Comparison of percentage of participants with a reduction of 50% or more in migraine frequency during the second month of treatment', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model with terms of treatment, baseline weekly migraine frequency and center included in the model.', 'testedNonInferiority': False}, {'pValue': '0.788', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '0.88', 'pValueComment': 'No adjustment for multiple comparisons was performed.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.52', 'estimateComment': '91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \\>=50% reduction in migraine frequency during the treatment period.', 'groupDescription': 'Comparison of percentage of participants with a reduction of 50% or more in migraine frequency during the third month of treatment.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model with terms of treatment, baseline weekly migraine frequency and center included in the model.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month1, Month 2 and Month 3', 'description': 'The percentage of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) compared to Baseline at each month of the treatment period.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with available data. N indicates the number of participants with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Average Migraine Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '91-day Levonorgestrel Oral Contraceptive', 'description': 'Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.'}], 'classes': [{'title': '91-Day Treatment Period (N=54, 45)', 'categories': [{'measurements': [{'value': '-0.37', 'spread': '0.097', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.109', 'groupId': 'OG001'}]}]}, {'title': 'First Month (N=54, 45)', 'categories': [{'measurements': [{'value': '-0.55', 'spread': '0.138', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '0.154', 'groupId': 'OG001'}]}]}, {'title': 'Second Month (N= 51, 44)', 'categories': [{'measurements': [{'value': '-0.98', 'spread': '0.158', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '0.173', 'groupId': 'OG001'}]}]}, {'title': 'Third Month (N=40, 37)', 'categories': [{'measurements': [{'value': '-1.06', 'spread': '0.190', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '0.197', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.182', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '0.09', 'estimateComment': '91-day Levonogestrel Oral Contraceptive versus placebo.', 'groupDescription': 'Comparison of change from Baseline in migraine severity during the 91-day treatment period.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.', 'testedNonInferiority': False}, {'pValue': '0.853', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '0.19', 'estimateComment': '91-day Levonogestrel Oral Contraceptive versus placebo.', 'groupDescription': 'Comparison of change from Baseline in migraine severity during the first month of treatment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.', 'testedNonInferiority': False}, {'pValue': '0.249', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '0.19', 'estimateComment': '91-day Levonogestrel Oral Contraceptive versus placebo.', 'groupDescription': 'Comparison of change from Baseline in migraine severity during the second month of treatment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.', 'testedNonInferiority': False}, {'pValue': '0.119', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '0.10', 'estimateComment': '91-day Levonogestrel Oral Contraceptive versus placebo.', 'groupDescription': 'Comparison of change from Baseline in migraine severity during the third month of treatment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Month 1, Month 2 and Month 3', 'description': 'Migraine severity was recorded by participants in the Baseline qualification diary and study migraine diary during the treatment period. Participants could report a severity of none (score = 0), mild (1), moderate (2), or severe (3). In general, if a headache was mild, daily activities could be resumed and little to no medication was taken. Moderate headaches required medication and effected daily activities. Severe headaches were debilitating and required medication.\n\nAverage migraine severity is defined as the sum of the severity ratings divided by the total number of migraine episodes reported during the observation period (for example, Baseline, First Month, Second Month, Third Month, and 91-Day Treatment Period). A negative change from Baseline score indicates improvement in severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with available data. N indicates the number of participants with available data at each time period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Required Rescue Medications During the Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '91-day Levonorgestrel Oral Contraceptive', 'description': 'Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.'}], 'classes': [{'title': 'Baseline (N=54, 45)', 'categories': [{'measurements': [{'value': '85.2', 'groupId': 'OG000'}, {'value': '75.6', 'groupId': 'OG001'}]}]}, {'title': 'First Month (N=54, 45)', 'categories': [{'measurements': [{'value': '63.0', 'groupId': 'OG000'}, {'value': '55.6', 'groupId': 'OG001'}]}]}, {'title': 'Second Month (N=51, 44)', 'categories': [{'measurements': [{'value': '45.1', 'groupId': 'OG000'}, {'value': '54.5', 'groupId': 'OG001'}]}]}, {'title': 'Third Month (N=40, 37)', 'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000'}, {'value': '62.2', 'groupId': 'OG001'}]}]}, {'title': 'During the 91-day treatment period (N=54, 45)', 'categories': [{'measurements': [{'value': '72.2', 'groupId': 'OG000'}, {'value': '75.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.457', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of percentage of participants requiring rescue medication during the first month of treatment.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.361', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of percentage of participants requiring rescue medication during the second month of treatment.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.018', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of percentage of participants requiring rescue medication during the third month of treatment.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.709', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of percentage of participants requiring rescue medication during the 91-day treatment period.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 1, Month 2 and Month 3', 'description': 'Participants recorded use of rescue medications for migraines in the migraine diary during the course of study treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with available data. N indicates the number of participants with available data at each time period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Migraine Disability Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '91-day Levonorgestrel Oral Contraceptive', 'description': 'Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.8', 'spread': '16.26', 'groupId': 'OG000'}, {'value': '-8.5', 'spread': '10.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 15', 'description': "The migraine disability assessment (MIDAS) test is used to determine how severely migraines affect a patient's life. Participants were asked five questions about how often their headaches limited their ability to go to work or school, to do household work or to do family or leisure activities in the past 3 months.\n\nThe MIDAS score equals the sum of the days answered for each question and ranges from 0 (no disability) to approximately 270 (severe disability; the upper bound is dependent on the number of days a participant would plan to work or participate in other activities).\n\nThe MIDAS score is classified into four grades of severity:\n\n* 0 to 5: MIDAS Grade I, Little or no disability\n* 6 to 10: MIDAS Grade II, Mild disability\n* 11 to 20: MIDAS Grade III, Moderate disability\n* 21+: MIDAS Grade IV, Severe disability", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with available data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Headache Impact Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '91-day Levonorgestrel Oral Contraceptive', 'description': 'Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.'}], 'timeFrame': 'Baseline and Week 15', 'description': "The Headache Impact Test (HIT) is a tool used to measure the impact headaches have on patients' ability to function on the job, at school, at home and in social situations.\n\nHIT-6 consists of 6 questions each scored on a scale from Never (6 points) to Always (13 points). The total score ranges from 36 to 78 with higher scores indicating greater impact on life.\n\nThere was an error in administration of the HIT-6 in this study. Question 6 was not administered, and question 3 from the MIDAS was included instead. Therefore, the total score of the HIT-6 could not be calculated.", 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was not performed due to an error in the administration of the test.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '91-day Levonorgestrel Oral Contraceptive', 'description': 'Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Mild adverse event', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Moderate adverse event', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Severe adverse event', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Adverse event not related to study drug', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Adverse event possibly related to study drug', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Adverse event related to study drug', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other serious adverse event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Withdrawn due to adverse event', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 15 weeks', 'description': 'An AE is any untoward medical occurrence in a clinical investigation participant and which does not necessarily have to have a causal relationship with this treatment or clinical study.\n\nThe following definitions were used to assess AE severity: Mild: Awareness of signs or symptoms, but they are easily tolerated; Moderate: Enough discomfort to cause interference with usual activity; Severe: Incapacitating, with inability to perform usual activity.\n\nRelationship to study drug was assessed as either: None: Causal relationship can be ruled out; Possibly: Causal relationship at least reasonably possible, i.e. relationship cannot be ruled out; Definitely: Causal relationship is certain.\n\nA serious adverse event (SAE) is one that met any one of the following criteria:\n\n* Fatal or life threatening\n* Requires or prolongs in patient hospitalization\n* Results in persistent or significant disability/incapacity\n* Congenital anomaly / birth defect\n* Important medical event.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population, consisting of all participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Mean Number of Days of Bleeding or Spotting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '91-day Levonorgestrel Oral Contraceptive', 'description': 'Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.2', 'spread': '19.58', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '7.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '91-day treatment period', 'description': 'Bleeding and spotting were recorded by participants in the migraine diary during the 91-day treatment period.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population with available data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '91-day Levonorgestrel Oral Contraceptive', 'description': 'Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Noncompliance With Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other Reason, Unknown', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 304 women with menstrually related migraine were screened for enrollment at 37 study centers in the United States. Of the 304 screened, 109 women at 23 centers met entry criteria and were considered eligible for enrollment into the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '91-day Levonorgestrel Oral Contraceptive', 'description': 'Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.7', 'spread': '4.70', 'groupId': 'BG000'}, {'value': '27.4', 'spread': '3.83', 'groupId': 'BG001'}, {'value': '27.1', 'spread': '4.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '99', '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': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Intent-to-treat population includes all randomly assigned and treated participants who had at least 1 week of postbaseline migraine data.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'dispFirstSubmitDate': '2013-04-10', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-12', 'studyFirstSubmitDate': '2008-10-28', 'dispFirstSubmitQcDate': '2013-04-10', 'resultsFirstSubmitDate': '2014-08-19', 'studyFirstSubmitQcDate': '2008-10-28', 'dispFirstPostDateStruct': {'date': '2013-04-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-08-19', 'studyFirstPostDateStruct': {'date': '2008-10-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the Treatment Period', 'timeFrame': 'Baseline (25-35 days before Day 1) and Days 1-91', 'description': 'The number of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) through the end of the 91-day treatment period compared with Baseline (the 25- to 35-day baseline qualification period). Participants recorded the incidence, timing and intensity of migraines in a migraine diary during the prequalification period and throughout the 91-day treatment period.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the First, Second and Third Months', 'timeFrame': 'Baseline, Month1, Month 2 and Month 3', 'description': 'The percentage of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) compared to Baseline at each month of the treatment period.'}, {'measure': 'Change From Baseline in Average Migraine Severity', 'timeFrame': 'Baseline and Month 1, Month 2 and Month 3', 'description': 'Migraine severity was recorded by participants in the Baseline qualification diary and study migraine diary during the treatment period. Participants could report a severity of none (score = 0), mild (1), moderate (2), or severe (3). In general, if a headache was mild, daily activities could be resumed and little to no medication was taken. Moderate headaches required medication and effected daily activities. Severe headaches were debilitating and required medication.\n\nAverage migraine severity is defined as the sum of the severity ratings divided by the total number of migraine episodes reported during the observation period (for example, Baseline, First Month, Second Month, Third Month, and 91-Day Treatment Period). A negative change from Baseline score indicates improvement in severity.'}, {'measure': 'Percentage of Participants Who Required Rescue Medications During the Study Period', 'timeFrame': 'Baseline, Month 1, Month 2 and Month 3', 'description': 'Participants recorded use of rescue medications for migraines in the migraine diary during the course of study treatment.'}, {'measure': 'Change From Baseline in Migraine Disability Assessment', 'timeFrame': 'Baseline and Week 15', 'description': "The migraine disability assessment (MIDAS) test is used to determine how severely migraines affect a patient's life. Participants were asked five questions about how often their headaches limited their ability to go to work or school, to do household work or to do family or leisure activities in the past 3 months.\n\nThe MIDAS score equals the sum of the days answered for each question and ranges from 0 (no disability) to approximately 270 (severe disability; the upper bound is dependent on the number of days a participant would plan to work or participate in other activities).\n\nThe MIDAS score is classified into four grades of severity:\n\n* 0 to 5: MIDAS Grade I, Little or no disability\n* 6 to 10: MIDAS Grade II, Mild disability\n* 11 to 20: MIDAS Grade III, Moderate disability\n* 21+: MIDAS Grade IV, Severe disability"}, {'measure': 'Change From Baseline in Headache Impact Test', 'timeFrame': 'Baseline and Week 15', 'description': "The Headache Impact Test (HIT) is a tool used to measure the impact headaches have on patients' ability to function on the job, at school, at home and in social situations.\n\nHIT-6 consists of 6 questions each scored on a scale from Never (6 points) to Always (13 points). The total score ranges from 36 to 78 with higher scores indicating greater impact on life.\n\nThere was an error in administration of the HIT-6 in this study. Question 6 was not administered, and question 3 from the MIDAS was included instead. Therefore, the total score of the HIT-6 could not be calculated."}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 15 weeks', 'description': 'An AE is any untoward medical occurrence in a clinical investigation participant and which does not necessarily have to have a causal relationship with this treatment or clinical study.\n\nThe following definitions were used to assess AE severity: Mild: Awareness of signs or symptoms, but they are easily tolerated; Moderate: Enough discomfort to cause interference with usual activity; Severe: Incapacitating, with inability to perform usual activity.\n\nRelationship to study drug was assessed as either: None: Causal relationship can be ruled out; Possibly: Causal relationship at least reasonably possible, i.e. relationship cannot be ruled out; Definitely: Causal relationship is certain.\n\nA serious adverse event (SAE) is one that met any one of the following criteria:\n\n* Fatal or life threatening\n* Requires or prolongs in patient hospitalization\n* Results in persistent or significant disability/incapacity\n* Congenital anomaly / birth defect\n* Important medical event.'}, {'measure': 'Mean Number of Days of Bleeding or Spotting', 'timeFrame': '91-day treatment period', 'description': 'Bleeding and spotting were recorded by participants in the migraine diary during the 91-day treatment period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Migraine headache', 'menstrual', 'oral contraceptive', 'Menstrually-Related Migraine Headache'], 'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to evaluate the efficacy of a 91-day extended cycle oral contraceptive compared to placebo for decreasing the frequency and severity of menstrually-related migraine headaches.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '34 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premenopausal, non-pregnant, non-lactating\n* History of migraine headaches without aura for at least 6 months\n* History of migraine headaches associated with menstruation\n* Others as directed by FDA-approved protocol\n\nExclusion Criteria:\n\n* History of migraine headaches with aura or focal neurological symptoms\n* Any contraindication to the use of oral contraceptives\n* Others as dictated by FDA-approved protocol'}, 'identificationModule': {'nctId': 'NCT00781456', 'briefTitle': 'A Multicenter Study to Evaluate the Efficacy of a 91-Day Extended Cycle Oral Contraceptive for Menstrually-Related Migraine Headaches', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy of DR-105 Compared to Placebo For the Management of Menstrually-Related Migraine Headaches.', 'orgStudyIdInfo': {'id': 'DR-105-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '91-day Levonorgestrel Oral Contraceptive', 'description': 'Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy, for a total of 13 weeks.', 'interventionNames': ['Drug: 91-day Levonorgestrel Oral Contraceptive']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo, 12 weeks (84 consecutive days) of inactive tablets, followed by an additional 7 days of inactive tablets, for a total of 13 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': '91-day Levonorgestrel Oral Contraceptive', 'type': 'DRUG', 'otherNames': ['Seasonique', 'DR-105'], 'description': '91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE.', 'armGroupLabels': ['91-day Levonorgestrel Oral Contraceptive']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1 tablet daily to match experimental arm', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94109-4841', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20036', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Teva Investigational Site', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '08817', 'city': 'Edison', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 40.51872, 'lon': -74.4121}}, {'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva 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'Hilton Head', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site', 'geoPoint': {'lat': 32.21632, 'lon': -80.75261}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Teva Investigational Site', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75234', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23454', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Duramed Research Protocol Chair', 'role': 'STUDY_CHAIR', 'affiliation': 'Duramed Research, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duramed Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}