Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-25 @ 4:48 PM
Study NCT ID:
NCT01173003
Status:
COMPLETED
Last Update Posted:
2014-02-19
First Post:
2010-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expansion Study of a Simplified Regimen of Medical Abortion Thru 63 Last Menstrual Period (LMP) in Tunisia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015735', 'term': 'Mifepristone'}, {'id': 'D016595', 'term': 'Misoprostol'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011459', 'term': 'Prostaglandins E, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 688}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-18', 'studyFirstSubmitDate': '2010-07-28', 'studyFirstSubmitQcDate': '2010-07-29', 'lastUpdatePostDateStruct': {'date': '2014-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15.', 'timeFrame': '2 weeks after mifepristone administration'}], 'secondaryOutcomes': [{'measure': 'Side effects', 'timeFrame': '48 hours'}, {'measure': 'Acceptability for women', 'timeFrame': '2 weeks'}]}, 'conditionsModule': {'keywords': ['Medical abortion', 'mifepristone', 'misoprostol', 'Tunisia'], 'conditions': ['Induced Abortion']}, 'descriptionModule': {'briefSummary': 'This open-label study is being conducted to determine whether national expansion of a 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable to new abortion providers in 14 regions.\n\nThe goal of this study is to provide answers to the following four questions:\n\n1. What is the effectiveness of this regimen of medical abortion with mifepristone followed by 400 mcg sublingual misoprostol up to 63 days since the last menstrual period (LMP)?\n2. Are the side effects with sublingual use tolerable for women?\n3. Is sublingual administration of misoprostol acceptable to women?\n4. Are women satisfied with counseling and services received in new centers offering medical abortion?'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women presenting for medical abortion who consent to participate\n* Possibility of final gestational age of less than or equal to 63 days\n* General good health\n* Willing to provide contact information for purposes of follow-up\n\nExclusion Criteria:\n\n* Conditions which contraindicate the use of mifepristone or misoprostol\n* Women presenting for medical abortion who do not consent to participate'}, 'identificationModule': {'nctId': 'NCT01173003', 'briefTitle': 'Expansion Study of a Simplified Regimen of Medical Abortion Thru 63 Last Menstrual Period (LMP) in Tunisia', 'organization': {'class': 'OTHER', 'fullName': 'Gynuity Health Projects'}, 'officialTitle': 'An Open Label Study of 400 mcg Sublingual Misoprostol Following Mifepristone 200 mg for Abortion up to 63 Days LMP', 'orgStudyIdInfo': {'id': '1.1.7'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Mifepristone, misoprostol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tunis', 'state': 'Various', 'country': 'Tunisia', 'facility': "Centres (14) de Planification Familiale de L'ONFP", 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'overallOfficials': [{'name': 'Beverly Winikoff, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Gynuity Health Projects'}, {'name': 'Rasha Dabash, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gynuity Health Projects'}, {'name': 'Selma Hajri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reproductive Health Consultant'}, {'name': 'Mongia Ben Attia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Office Nationale de la Famille et de la Population'}, {'name': 'N Gueddana, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'ONFP'}, {'name': 'Fatma Temimi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ONFP'}, {'name': 'E Hassairi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ONFP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynuity Health Projects', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre de Formation et de la Recherche, Tunisia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}