Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT01129102
Status:
COMPLETED
Last Update Posted:
2025-03-05
First Post:
2010-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004412', 'term': 'Dysmenorrhea'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'murakami@nobelpharma.co.jp', 'phone': '+81-5651-1177', 'title': 'Department director of clinical development department 1', 'organization': 'Nobelpharma'}, 'certainAgreement': {'otherDetails': "There is an agreement between the sponsor and PI that no restricts the PI's right but need to discuss the timing of publish date of trial results after the trial is completed.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'NPC-01', 'description': 'Norethisterone 1mg, Ethinyl estradiol 0.02mg\n\nNPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg', 'otherNumAtRisk': 107, 'otherNumAffected': 103, 'seriousNumAtRisk': 107, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'IKH-01', 'description': 'Norethisterone 1mg, Ethinyl estradiol 0.035mg\n\nIKH-01: Norethisterone 1mg, Ethinyl estradiol 0.035mg', 'otherNumAtRisk': 47, 'otherNumAffected': 45, 'seriousNumAtRisk': 47, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo for NPC-01\n\nPlacebo: Placebo for NPC-01', 'otherNumAtRisk': 54, 'otherNumAffected': 44, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 13.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 19, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 13.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 13.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 13.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 71, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 31, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 13.1'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 13.1'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 41, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 17, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 13.1'}, {'term': 'Hypomenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 13.1'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 13.1'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 165, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 71, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 35, 'numAffected': 21}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 13.1'}, {'term': 'Oligomenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 38, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 13.1'}, {'term': 'Polymenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 13.1'}, {'term': 'Breast discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 13.1'}], 'seriousEvents': [{'term': 'Abdominal pain lower (Dysmenorrhoea aggravated)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-J 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NPC-01', 'description': 'Norethisterone 1mg, Ethinyl estradiol 0.02mg\n\nNPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for NPC-01\n\nPlacebo: Placebo for NPC-01'}], 'classes': [{'title': 'Pretreatment', 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '0.95', 'groupId': 'OG001'}]}]}, {'title': 'End of treatment', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16weeks', 'description': 'The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work\n\nDrug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary endpoints were analysed based on FAS population. Data unavailable for IKH-01 group because IKH-01 group only assigned for secondary dysmenorrhea.'}, {'type': 'SECONDARY', 'title': 'Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NPC-01', 'description': 'Norethisterone 1mg, Ethinyl estradiol 0.02mg\n\nNPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for NPC-01\n\nPlacebo: Placebo for NPC-01'}], 'classes': [{'title': 'Pretreatment', 'categories': [{'measurements': [{'value': '51.8', 'spread': '20.57', 'groupId': 'OG000'}, {'value': '48.6', 'spread': '20.15', 'groupId': 'OG001'}]}]}, {'title': 'End of treatment', 'categories': [{'measurements': [{'value': '21.2', 'spread': '20.18', 'groupId': 'OG000'}, {'value': '35.6', 'spread': '21.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16weeks', 'description': 'VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was carried out based on FAS population. IKH-01 was not allocated for primary dysmenorrhea in this study. Therefore, VAS for primary dysmenorrhea is not available in IKH-01 group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NPC-01', 'description': 'Norethisterone 1mg, Ethinyl estradiol 0.02mg\n\nNPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg'}, {'id': 'FG001', 'title': 'IKH-01', 'description': 'Norethisterone 1mg, Ethinyl estradiol 0.035mg\n\nIKH-01: Norethisterone 1mg, Ethinyl estradiol 0.035mg'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo for NPC-01\n\nPlacebo: Placebo for NPC-01'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'No study drug treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'NPC-01', 'description': 'Norethisterone 1mg, Ethinyl estradiol 0.02mg'}, {'id': 'BG001', 'title': 'IKH-01', 'description': 'Norethisterone 1mg, Ethinyl estradiol 0.035mg'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo for NPC-01'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.4', 'spread': '7.29', 'groupId': 'BG000'}, {'value': '34.0', 'spread': '6.93', 'groupId': 'BG001'}, {'value': '30.4', 'spread': '7.41', 'groupId': 'BG002'}, {'value': '32.3', 'spread': '7.21', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Under 30 years of age', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}]}, {'title': '30 year of age and older', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diagnostic categories', 'classes': [{'title': 'Primary dysmenorrhea', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}]}, {'title': 'Secondary dysmenorrhea', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '123', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Total dysmenorrhea score', 'classes': [{'title': 'Total dysmenorrhea', 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.00', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'IKH-01 was not allocated for primary dysmenorrhea in this study. Therefore, total dysmenorrhea score is not available for IKH-01 group.', 'groupId': 'BG001'}, {'value': '4.2', 'spread': '0.95', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data unavailable for IKH-01 group', 'groupId': 'BG003'}]}]}, {'title': 'Primary dysmenorrhea', 'categories': [{'measurements': [{'value': '3.9', 'spread': '0.92', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'IKH-01 was not allocated for primary dysmenorrhea in this study.', 'groupId': 'BG001'}, {'value': '4.3', 'spread': '0.90', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data unavailable for IKH-01 group', 'groupId': 'BG003'}]}]}, {'title': 'Secondary dysmenorrhea', 'categories': [{'measurements': [{'value': '4.3', 'spread': '1.05', 'groupId': 'BG000'}, {'value': '4.0', 'spread': '0.87', 'groupId': 'BG001'}, {'value': '4.1', 'spread': '0.99', 'groupId': 'BG002'}, {'value': '4.1', 'spread': '0.96', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work\n\nDrug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Visual analogue scale (VAS) for primary dysmenorrhea', 'classes': [{'categories': [{'measurements': [{'value': '51.8', 'spread': '20.57', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'IKH-01 was not allocated for primary dysmenorrhea in this study. Therefore, VAS for primary dysmenorrhea is not available for IKH-01 group.', 'groupId': 'BG001'}, {'value': '48.6', 'spread': '20.15', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data unavailable for IKH-01 group', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline analysis population was carried out based on FAS data set. 110, 50 and 55 pts were assigned to NPC-01, IKH-01 and placebo, respectively, and administered study drug 108, 47 and 54 pts. Safety and FAS analysis was carried out on 107, 47 and 54 pts/105, 47 and 54 pts due to 1 and 2 pts of NPC-01 have no available data respectively.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2010-05-21', 'resultsFirstSubmitDate': '2014-04-10', 'studyFirstSubmitQcDate': '2010-05-21', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-05-15', 'studyFirstPostDateStruct': {'date': '2010-05-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)', 'timeFrame': '16weeks', 'description': 'The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work\n\nDrug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days'}], 'secondaryOutcomes': [{'measure': 'Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment)', 'timeFrame': '16weeks', 'description': 'VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dysmenorrhea']}, 'referencesModule': {'references': [{'pmid': '37523477', 'type': 'DERIVED', 'citation': 'Schroll JB, Black AY, Farquhar C, Chen I. Combined oral contraceptive pill for primary dysmenorrhoea. Cochrane Database Syst Rev. 2023 Jul 31;7(7):CD002120. doi: 10.1002/14651858.CD002120.pub4.'}, {'pmid': '27717552', 'type': 'DERIVED', 'citation': 'Harada T, Momoeda M. Evaluation of an ultra-low-dose oral contraceptive for dysmenorrhea: a placebo-controlled, double-blind, randomized trial. Fertil Steril. 2016 Dec;106(7):1807-1814. doi: 10.1016/j.fertnstert.2016.08.051. Epub 2016 Oct 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea.', 'detailedDescription': 'The main objective of this study is to confirm the effectiveness and safety profile of NPC-01 in comparison with placebo in the treatment of dysmenorrhea (primary and secondary dysmenorrhea).\n\nAdditionally we also investigate the differences of effectiveness of NPC-01 in comparison with IKH-01 in the treatment of secondary dysmenorrhea as a reference, because IKH-01 is already marketed at them.\n\nTo achieve these, closed testing procedure is used in this study. After confirming statistical differences between NPC-01 and Placebo in the total dysmenorrhea, stratified analysis is carried out for primary dysmenorrhea (NPC-01, Placebo), and secondary dysmenorrhea (NPC-01, IKH-01 and Placebo).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* dysmenorrhea\n\nExclusion Criteria:\n\n* severe hepatopathy\n* pregnant woman'}, 'identificationModule': {'nctId': 'NCT01129102', 'briefTitle': 'Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nobelpharma'}, 'officialTitle': 'Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea', 'orgStudyIdInfo': {'id': 'NPC-01-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NPC-01', 'description': 'Norethisterone 1mg, Ethinyl estradiol 0.02mg', 'interventionNames': ['Drug: NPC-01']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IKH-01', 'description': 'Norethisterone 1mg, Ethinyl estradiol 0.035mg', 'interventionNames': ['Drug: IKH-01']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for NPC-01', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'NPC-01', 'type': 'DRUG', 'description': 'Norethisterone 1mg, Ethinyl estradiol 0.02mg', 'armGroupLabels': ['NPC-01']}, {'name': 'IKH-01', 'type': 'DRUG', 'description': 'Norethisterone 1mg, Ethinyl estradiol 0.035mg', 'armGroupLabels': ['IKH-01']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for NPC-01', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Naoki Terakawa, M.D.,Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nissay Hospital,Osaka,Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nobelpharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}