Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT01074151
Status:
COMPLETED
Last Update Posted:
2022-07-18
First Post:
2010-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Cymbalta Pregnancy Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-15', 'studyFirstSubmitDate': '2010-02-22', 'studyFirstSubmitQcDate': '2010-02-22', 'lastUpdatePostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To estimate the risk of major congenital anomalies among pregnancies exposed to Cymbalta', 'timeFrame': 'maximum of 22 months'}], 'secondaryOutcomes': [{'measure': 'To estimate risk of recognized spontaneous abortions, stillbirths, elective terminations, minor congenital anomalies, and any serious adverse pregnancy outcomes among pregnancies exposed to Cymbalta and their live births during the first year of life', 'timeFrame': 'maximum of 22 months'}, {'measure': 'To examine any potential impact of Cymbalta use while breastfeeding on the infant during the first year of life', 'timeFrame': 'maximum of 22 months'}, {'measure': 'To compare the risk of major congenital anomalies among pregnancies exposed to Cymbalta to an appropriate comparator(s) such as the Centers for Disease Control and Prevention (CDC) Metropolitan Atlanta Congenital Defects Program (MACDP)', 'timeFrame': 'maximum of 22 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pregnancy', 'pregnant', 'Cymbalta', 'Pregnancy Outcomes'], 'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'The Cymbalta Pregnancy Registry is a U.S. based Registry designed to monitor women who are exposed to Cymbalta (duloxetine) during pregnancy. This is an observational, exposure-registration and follow-up registry.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant patients exposed to Cymbalta (duloxetine) at any time during pregnancy, beginning on or after the first day of the last menstrual period', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sufficient evidence (e.g., date or gestational age) to confirm that Cymbalta exposure occurred during pregnancy\n* Sufficient data to establish in which trimester of pregnancy the exposure to Cymbalta first occurred (i.e., first, second or third trimester)\n* Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (i.e., whether the outcome of pregnancy was known at the time of first contact with the Registry)\n* Date the pregnancy exposure is reported to the Registry\n* Source of the report (Health Care Professional or pregnant patient)\n* Full contact information for the reporter and Health Care Professional willing and able to provide accurate pregnancy-related information (name, address, phone number, etc.)\n\nExclusion Criteria:\n\n* Reported cases that do not meet the minimum criteria for Registry enrollment are deemed ineligible.'}, 'identificationModule': {'nctId': 'NCT01074151', 'briefTitle': 'The Cymbalta Pregnancy Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'The Cymbalta Pregnancy Registry', 'orgStudyIdInfo': {'id': '12938'}, 'secondaryIdInfos': [{'id': 'F1J-MC-B034', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant patients exposed to Cymbalta', 'description': 'Pregnant patients exposed to Cymbalta (duloxetine) at any time during pregnancy, beginning on or after the first day of the last menstrual period', 'interventionNames': ['Drug: duloxetine']}], 'interventions': [{'name': 'duloxetine', 'type': 'DRUG', 'description': 'any exposure to duloxetine that occurred during pregnancy', 'armGroupLabels': ['Pregnant patients exposed to Cymbalta']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28405', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Cymbalta Pregnancy Registry Call Center', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}], 'overallOfficials': [{'name': 'INC Research, LLC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Syneos Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Syneos Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}