Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT00230802
Status:
COMPLETED
Last Update Posted:
2016-12-23
First Post:
2005-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Thyroid Hormone Dose Adjustment in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007037', 'term': 'Hypothyroidism'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013974', 'term': 'Thyroxine'}], 'ancestors': [{'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ekalexander@partners.org', 'phone': '6177325666', 'title': 'Erik Alexander, MD', 'organization': "Brigham & Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '2 Tablet Increase', 'description': 'Patients will increase their current levothyroxine dose by 2 extra tablets per week (\\~29% increase)', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '3 Tablet Increase', 'description': 'Patients will increase their levothyroxine dosage by 3 extra tablets per week (\\~43%).', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2 Tablet Increase', 'description': 'Patients will increase their current levothyroxine dose by 2 extra tablets per week (\\~29% increase)'}, {'id': 'OG001', 'title': '3 Tablet Increase', 'description': 'Patients will increase their levothyroxine dosage by 3 extra tablets per week (\\~43%).'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 months', 'description': 'The proportion of patients in each treatment arm euthyroid through gestation', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'proportion of patients in each treatment arm euthyroid through gestation'}, {'type': 'SECONDARY', 'title': 'the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2 Tablet Increase', 'description': 'Patients will increase their current levothyroxine dose by 2 extra tablets per week (\\~29% increase)\n\nAnticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.\n\nlevothyroxine: patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week'}, {'id': 'OG001', 'title': '3 Tablet Increase', 'description': 'Patients will increase their levothyroxine dosage by 3 extra tablets per week (\\~43%).\n\nAnticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.\n\nlevothyroxine: patients will increase levothyroxine by 3 extra tablets of their current dose per week.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '2 Tablet Increase', 'description': 'Patients will increase their current levothyroxine dose by 2 extra tablets per week (\\~29% increase)\n\nAnticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.\n\nlevothyroxine: patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week'}, {'id': 'OG001', 'title': '3 Tablet Increase', 'description': 'Patients will increase their levothyroxine dosage by 3 extra tablets per week (\\~43%).\n\nAnticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.\n\nlevothyroxine: patients will increase levothyroxine by 3 extra tablets of their current dose per week.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '2 Tablet Increase', 'description': 'Patients will increase their current levothyroxine dose by 2 extra tablets per week (\\~29% increase)'}, {'id': 'FG001', 'title': '3 Tablet Increase', 'description': 'Patients will increase their levothyroxine dosage by 3 extra tablets per week (\\~43%).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '2 Tablet Increase', 'description': 'Patients will increase their current levothyroxine dose by 2 extra tablets per week (\\~29% increase)'}, {'id': 'BG001', 'title': '3 Tablet Increase', 'description': 'Patients will increase their levothyroxine dosage by 3 extra tablets per week (\\~43%).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29', 'spread': '3', 'groupId': 'BG000'}, {'value': '28', 'spread': '5', 'groupId': 'BG001'}, {'value': '29', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-31', 'studyFirstSubmitDate': '2005-09-29', 'resultsFirstSubmitDate': '2012-05-29', 'studyFirstSubmitQcDate': '2005-09-29', 'lastUpdatePostDateStruct': {'date': '2016-12-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-31', 'studyFirstPostDateStruct': {'date': '2005-10-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients in Each Treatment Arm Euthyroid Through Gestation', 'timeFrame': '9 months', 'description': 'The proportion of patients in each treatment arm euthyroid through gestation'}], 'secondaryOutcomes': [{'measure': 'the Participants in Each Arm Who Required Levothyroxine Dose Adjustments (Either Increased or Decreased) Occurred to Maintain a Euthyroid State', 'timeFrame': '9 months'}, {'measure': 'Proportion of Subjects With Abnormal Thyroid Stimulating Hormone Values When Following an Every 4 Week Monitoring Schedule During Pregnancy.', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pregnancy', 'hypothyroidism', 'levothyroxine'], 'conditions': ['Pregnancy', 'Hypothyroidism']}, 'referencesModule': {'references': [{'pmid': '20463094', 'type': 'RESULT', 'citation': 'Yassa L, Marqusee E, Fawcett R, Alexander EK. Thyroid hormone early adjustment in pregnancy (the THERAPY) trial. J Clin Endocrinol Metab. 2010 Jul;95(7):3234-41. doi: 10.1210/jc.2010-0013. Epub 2010 May 12.'}]}, 'descriptionModule': {'briefSummary': 'Our aim is to compare the safety and efficacy of 2 different empiric levothyroxine dose adjustment recommendations to be made at the first confirmation of pregnancy in women with a history of hypothyroidism. Subjects will be women with a prior diagnosis of hypothyroidism who are taking thyroid hormone replacement and who are less than 8 weeks pregnant. Upon confirmation of pregnancy, subjects will be randomized to increase their weekly thyroid hormone dose by either 2 or 3 tablets (28 or 42%). Thyroid function will be evaluated every two weeks in the first 20 weeks and then again at week 30 and post-partum. Primary endpoints will be the proportion of women in each group who remain euthyroid throughout the first trimester and throughout pregnancy.', 'detailedDescription': 'Our aim is to compare the safety and efficacy of 2 different empiric levothyroxine dose adjustment recommendations to be made at the first confirmation of pregnancy in women with a history of hypothyroidism. Subjects will be women with a prior diagnosis of hypothyroidism who are taking thyroid hormone replacement and who are less than 8 weeks pregnant. Upon confirmation of pregnancy, subjects will be randomized to increase their weekly thyroid hormone dose by either 2 or 3 tablets (28 or 42%). Thyroid function will be evaluated every two weeks in the first 20 weeks and then again at week 30 and post-partum. Primary endpoints will be the proportion of women in each group who remain euthyroid throughout the first trimester and throughout pregnancy'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with a prior diagnosis of hypothyroidism, currently receiving levothyroxine therapy\n* less than 8 weeks pregnant\n\nExclusion Criteria:\n\n* cardiac disease, renal failure\n* not euthyroid biochemically within 6 months pre-pregnancy'}, 'identificationModule': {'nctId': 'NCT00230802', 'briefTitle': 'Thyroid Hormone Dose Adjustment in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Thyroid Hormone Dose Adjustments During Pregnancy in Women With Primary Hypothyroidism.', 'orgStudyIdInfo': {'id': 'DK44128 (completed)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2 tablet increase', 'description': 'Patients will increase their current levothyroxine dose by 2 extra tablets per week (\\~29% increase)', 'interventionNames': ['Drug: Anticipatory dose increase of levothyroxine', 'Drug: levothyroxine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3 tablet increase', 'description': 'Patients will increase their levothyroxine dosage by 3 extra tablets per week (\\~43%).', 'interventionNames': ['Drug: Anticipatory dose increase of levothyroxine', 'Drug: levothyroxine']}], 'interventions': [{'name': 'Anticipatory dose increase of levothyroxine', 'type': 'DRUG', 'otherNames': ['Levoxyl,', 'Synthroid,', 'Unithroid'], 'description': 'as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.', 'armGroupLabels': ['2 tablet increase', '3 tablet increase']}, {'name': 'levothyroxine', 'type': 'DRUG', 'otherNames': ['levoxyl,', 'synthroid', 'unithroid'], 'description': 'patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week', 'armGroupLabels': ['2 tablet increase']}, {'name': 'levothyroxine', 'type': 'DRUG', 'otherNames': ['Levoxyl,', 'Synthroid,', 'Unithroid'], 'description': 'patients will increase levothyroxine by 3 extra tablets of their current dose per week.', 'armGroupLabels': ['3 tablet increase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Erik Alexander, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Erik K. Alexander', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}