Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT00286208
Status:
COMPLETED
Last Update Posted:
2014-02-19
First Post:
2006-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1443}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-18', 'studyFirstSubmitDate': '2006-02-01', 'studyFirstSubmitQcDate': '2006-02-01', 'lastUpdatePostDateStruct': {'date': '2014-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', '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'], 'conditions': ['Induced Abortion']}, 'descriptionModule': {'briefSummary': 'This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable at inducing an abortion compared with misoprostol taken orally.\n\nThe goal of this study is to provide answers to the following four questions:\n\n1. Is a regimen of medical abortion with mifepristone using sublingual misoprostol at least as effective as using oral 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. Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety (side-effects) or acceptability?'}, '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': 'NCT00286208', 'briefTitle': 'Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation', 'organization': {'class': 'OTHER', 'fullName': 'Gynuity Health Projects'}, 'officialTitle': 'A Randomized Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation', 'orgStudyIdInfo': {'id': '1.1.5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sublingual Misoprostol', 'description': '400 mcg of sublingual misoprostol', 'interventionNames': ['Drug: Mifepristone, misoprostol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Misoprostol', 'description': 'Misoprostol administered orally', 'interventionNames': ['Drug: Mifepristone, misoprostol']}], 'interventions': [{'name': 'Mifepristone, misoprostol', 'type': 'DRUG', 'armGroupLabels': ['Oral Misoprostol', 'Sublingual Misoprostol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chisinau', 'country': 'Moldova', 'facility': 'State University of Medicine and Pharmacy', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'city': 'Aryanah', 'country': 'Tunisia', 'facility': "Centre de Planification Familiale de l'Ariana", 'geoPoint': {'lat': 36.86012, 'lon': 10.19337}}, {'city': 'Tunis', 'country': 'Tunisia', 'facility': 'Centre de Planification Familiale la Bardo', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}, {'city': 'Tunis', 'country': 'Tunisia', 'facility': 'Maternité de La Rabta', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}, {'city': 'Tunis', 'country': 'Tunisia', 'facility': 'Private clinic', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}, {'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': "Dr. Zekai Tahir Burak Women's Health Training and Research Hospital", 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'MoH Ankara Etlik Maternity and Gyneacological Training Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Haydarpaşa Numune Training and Research Hospital Family Planning Clinic', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege Maternity and Gyneacological Training and Research Hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Sheila Raghavan, M.Sc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gynuity Health Projects'}, {'name': 'Beverly Winikoff, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', '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': 'Ayse Akin, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baskent University'}, {'name': 'Ilana Dzuba, MHS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gynuity Health Projects'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynuity Health Projects', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}