Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:59 PM
Study NCT ID:
NCT00386867
Status:
COMPLETED
Last Update Posted:
2007-06-05
First Post:
2006-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000278', 'term': 'Administration, Buccal'}], 'ancestors': [{'id': 'D000284', 'term': 'Administration, Oral'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000287', 'term': 'Administration, Topical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2007-03'}, 'lastUpdateSubmitDate': '2007-06-01', 'studyFirstSubmitDate': '2006-10-10', 'studyFirstSubmitQcDate': '2006-10-10', 'lastUpdatePostDateStruct': {'date': '2007-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'efficacy'}], 'secondaryOutcomes': [{'measure': 'acceptability'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['medical abortion', 'mifepristone', 'misoprostol', 'buccal administration'], 'conditions': ['Abortion, Induced']}, 'referencesModule': {'references': [{'pmid': '19037040', 'type': 'DERIVED', 'citation': 'Winikoff B, Dzuba IG, Creinin MD, Crowden WA, Goldberg AB, Gonzales J, Howe M, Moskowitz J, Prine L, Shannon CS. Two distinct oral routes of misoprostol in mifepristone medical abortion: a randomized controlled trial. Obstet Gynecol. 2008 Dec;112(6):1303-1310. doi: 10.1097/AOG.0b013e31818d8eb4.'}], 'seeAlsoLinks': [{'url': 'http://www.gynuity.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This open-label, randomized study will compare the efficacy, safety, and acceptability of mifepristone 200 mg followed in 24-36 hours either by buccal (i.e., in the cheeks) or oral misoprostol 800 mcg for termination of pregnancy in women up to 63 days L.M.P.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* be willing and able to sign consent forms;\n* be eligible for medical abortion according to clinician's assessment;\n* be willing to undergo a surgical completion if necessary;\n* have ready and easy access to a telephone and emergency transportation;\n* speak English, Spanish, or have a translator available to translate for all study procedures; and,\n* agree to comply with the study procedures and visit schedule.\n\nExclusion Criteria:\n\n* Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;\n* IUD in place;\n* Chronic renal failure;\n* Concurrent long-term corticosteroid therapy;\n* History of allergy to mifepristone, misoprostol or other prostaglandin;\n* Hemorrhagic disorders or concurrent anticoagulant therapy;\n* Inherited porphyrias; or\n* Other serious physical or mental health conditions."}, 'identificationModule': {'nctId': 'NCT00386867', 'briefTitle': 'A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP', 'organization': {'class': 'OTHER', 'fullName': 'Gynuity Health Projects'}, 'orgStudyIdInfo': {'id': '1.1.3'}}, 'armsInterventionsModule': {'interventions': [{'name': '800 mcg misoprostol via oral or buccal administration', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Family Planning Associates Medical Group', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Planned Parenthood League of Massachusetts (Boston clinic)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center, Division of Obstetrics & Gynecology', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Institute for Urban Family Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Parkmed', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh, Division of Obstetrics, Gynecology and Reproductive Sciences', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': "Whole Women's Health", 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Planned Parenthood', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}], 'overallOfficials': [{'name': 'Beverly Winikoff, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynuity Health Projects'}, {'name': 'Ilana Dzuba, MHS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gynuity Health Projects'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynuity Health Projects', 'class': 'OTHER'}}}}