Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-25 @ 3:15 PM
Study NCT ID:
NCT00269568
Status:
COMPLETED
Last Update Posted:
2016-01-29
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mifepristone at Same Time Multicenter Study
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-28', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-12-21', 'lastUpdatePostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete abortion rate', 'timeFrame': '5 weeks after treatment'}], 'secondaryOutcomes': [{'measure': 'to compare complete abortion rates by gestational age', 'timeFrame': '5 weeks after treatment'}, {'measure': 'compare bleeding and side effect profiles', 'timeFrame': 'up to 5 weeks after treatment'}, {'measure': 'compare acceptability of the two regimens', 'timeFrame': '2 weeks after treatment'}, {'measure': 'compare the expression of EP3 receptor mRNA in cervical tissue 2 and 24 hours after mifepristone treatment to pretreatment control', 'timeFrame': 'up to 24 hours after treatment'}, {'measure': 'measure time to first ovulation', 'timeFrame': 'up to 10 weeks after treatment'}, {'measure': 'compare elapsed time to ovulation between treatment regimens', 'timeFrame': 'up to 10 weeks after treatment'}, {'measure': 'evaluate continuation rates of combined hormonal contraceptives in women with immediate initiation versus traditional Sunday start', 'timeFrame': 'up to 12 weeks after treatment'}, {'measure': 'describe the prevalence of domestic violence in a medical abortion research population', 'timeFrame': 'at time of enrollment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['medical abortion', 'mifepristone', 'misoprostol'], 'conditions': ['Abortion Seekers']}, 'referencesModule': {'references': [{'pmid': '17400850', 'type': 'RESULT', 'citation': 'Creinin MD, Schreiber CA, Bednarek P, Lintu H, Wagner MS, Meyn LA; Medical Abortion at the Same Time (MAST) Study Trial Group. Mifepristone and misoprostol administered simultaneously versus 24 hours apart for abortion: a randomized controlled trial. Obstet Gynecol. 2007 Apr;109(4):885-94. doi: 10.1097/01.AOG.0000258298.35143.d2.'}, {'pmid': '18555814', 'type': 'RESULT', 'citation': 'Bednarek PH, Nichols MD, Carlson N, Edelman AB, Creinin MD, Truitt S, Jensen JT. Effect of "observed start" vs. traditional "Sunday start" on hormonal contraceptive continuation rates after medical abortion. Contraception. 2008 Jul;78(1):26-30. doi: 10.1016/j.contraception.2008.02.012. Epub 2008 May 6.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized study. 564 healthy women, age 18 years or older, with an intrauterine pregnancy, and requesting a medical abortion, will be recruited to participate in this prospective clinical trial. This study will provide an evaluation of oral mifepristone 200 mg and vaginal misoprostol 800 mcg administered simultaneously in women up to 63 days gestation. The aims of the study are to compare the complete abortion rates, at 7 and 14 days after misoprostol administration, when using mifepristone 200 mg orally and misoprostol 800 mcg vaginally are administered simultaneously and 24 hours apart in women up to 63 days gestation. Assessment of side effects (nausea, vomiting, pain) as well as acceptability will be done using pre and post-study questionnaires, and visual analogue scales. Complete abortion rate within 24 hours is expected to be 90%', 'detailedDescription': 'This is a multicenter, randomized study. 564 healthy women, age 18 years or older, with an intrauterine pregnancy, and requesting a medical abortion, will be recruited to participate in this prospective clinical trial. This study will provide an evaluation of oral mifepristone 200 mg and vaginal misoprostol 800 mcg administered simultaneously in women up to 63 days gestation. The aims of the study are to compare the complete abortion rates, at 7 and 14 days after misoprostol administration, when using mifepristone 200 mg orally and misoprostol 800 mcg vaginally are administered simultaneously and 24 hours apart in women up to 63 days gestation. Assessment of side effects (nausea, vomiting, pain) as well as acceptability will be done using pre and post-study questionnaires, and visual analogue scales. Complete abortion rate within 24 hours is expected to be 90%.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:pregnancy equal to or less than 63 days at enrollment -\n\nExclusion Criteria:abnormal pregnancy diagnosed by ultrasound\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00269568', 'acronym': 'MAST', 'briefTitle': 'Mifepristone at Same Time Multicenter Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'A Multicenter, Randomized Comparison of Mifepristone and Misoprostol Administered Simultaneously Versus 24 Hours Apart for Abortion Through 63 Days', 'orgStudyIdInfo': {'id': 'pittirb0404133'}}, 'armsInterventionsModule': {'interventions': [{'name': 'mifepristone and misoprostol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '97201', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee-Womens Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Mitchell D Creinin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universtity of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}