Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2026-03-12 @ 5:55 AM
Study NCT ID:
NCT00133705
Status:
COMPLETED
Last Update Posted:
2023-09-25
First Post:
2005-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Mifepristone for Fibroids
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015735', 'term': 'Mifepristone'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kevin_fiscella@urmc.rochester.edu', 'phone': '585-271-1206', 'title': 'Dr. Kevin Fiscella', 'phoneExt': '205', 'organization': 'University of Rochester'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'There were no adverse events in this clinical trial.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment Group', 'description': 'This group will receive 5 mg. capsules to be taken once daily.', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Group', 'description': 'These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Uterine Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'This group will receive 5 mg. capsules to be taken once daily.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '719', 'spread': '663', 'groupId': 'OG000'}, {'value': '449', 'spread': '236', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Uterine volume is measured in mLs', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Group', 'description': 'This group will receive 5 mg. capsules to be taken once daily.'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': 'These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Women were recruited between March 3, 2004 and March 30, 2005 through local media and contacts with community physicians.', 'preAssignmentDetails': '38 women were deemed ineligible. Of those exclusion criteria applied to 27 and 11 declined participation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mifepristone 5 mg.', 'description': 'Twenty-two women received 5 mg. mifepristone daily.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Twenty women received a placebo pill daily.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.8', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '43.2', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '43.0', 'spread': '5.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-05', 'studyFirstSubmitDate': '2005-08-22', 'resultsFirstSubmitDate': '2012-11-01', 'studyFirstSubmitQcDate': '2005-08-22', 'lastUpdatePostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-11-01', 'studyFirstPostDateStruct': {'date': '2005-08-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uterine Volume', 'timeFrame': '6 months', 'description': 'Uterine volume is measured in mLs'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['A benign tumor derived from smooth uterine muscle tissue.'], 'conditions': ['Leiomyoma']}, 'referencesModule': {'references': [{'pmid': '15922980', 'type': 'BACKGROUND', 'citation': 'Eisinger SH, Bonfiglio T, Fiscella K, Meldrum S, Guzick DS. Twelve-month safety and efficacy of low-dose mifepristone for uterine myomas. J Minim Invasive Gynecol. 2005 May-Jun;12(3):227-33. doi: 10.1016/j.jmig.2005.01.022.'}, {'pmid': '12576246', 'type': 'BACKGROUND', 'citation': 'Eisinger SH, Meldrum S, Fiscella K, le Roux HD, Guzick DS. Low-dose mifepristone for uterine leiomyomata. Obstet Gynecol. 2003 Feb;101(2):243-50. doi: 10.1016/s0029-7844(02)02511-5.'}, {'pmid': '17138770', 'type': 'DERIVED', 'citation': 'Fiscella K, Eisinger SH, Meldrum S, Feng C, Fisher SG, Guzick DS. Effect of mifepristone for symptomatic leiomyomata on quality of life and uterine size: a randomized controlled trial. Obstet Gynecol. 2006 Dec;108(6):1381-7. doi: 10.1097/01.AOG.0000243776.23391.7b.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to determine if low-dose mifepristone benefits women with symptomatic fibroids.', 'detailedDescription': 'This trial is designed to assess the efficacy and tolerability of mifepristone 5 mg given daily for 6 months to pre-menopausal women with symptomatic fibroids. The primary study outcome will be disease-specific quality of life. Secondary outcome measures include global quality of life, pain, bleeding, potential adverse effects, tumor size, and endometrial effects. The researchers will also examine a the effect of mifepristone on uterine blood flow. Randomization of study subjects will be stratified in order to ensure that equal numbers of women with moderate and severe symptoms will be enrolled in the placebo and control groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Gender: Female\n* Age: 18 - premenopausal\n* Have at least moderate symptoms of menorrhagia or pelvic pain/pressure\n* Have a total uterine volume greater than or equal to 160 cc by ultrasound measurement and at least one fibroid that is =\\> 2.5cm in size\n* Have a score of equal to or greater than 39 on the Uterine Fibroid Symptom and Quality of Life scale\n* Declined standard treatment options for symptomatic fibroids\n* Agree to use a double-barrier method (condoms, diaphragms) or other effective non-hormonal methods of contraception (abstinence, sterilization) throughout participation in the study to prevent pregnancy and to report any exposure to pregnancy to the research staff immediately\n* Willing and able to give informed consent\n* Willing and able to comply with study requirements\n\nExclusion Criteria:\n\n* Current or planned pregnancy during the study period\n* Menopausal, as indicated by follicle stimulating hormone (FSH) level of the reference laboratory\n* Currently breast-feeding\n* Untreated abnormal pap smear\n* Presence of conditions other than fibroids contributing to pain and/or bleeding\n* Hemoglobin \\< 9.0 mg/dl\n* Presence of adnexal masses or tenderness indicating further evaluation or surgery\n* Grade III or IV hydronephrosis by ultrasound\n* Severe, active mental health disorder\n* Active substance abuse or dependence\n* Presence of any contraindication to mifepristone including:\n\n * Adrenal insufficiency by history\n * Sickle cell disease\n * Active liver disease (liver function tests greater than 1.5 times upper range of normal)\n * Severe, respiratory disease (P02 saturation\\< 92%)\n * Renal disease (serum creatinine \\> 1.5 mg/dl)\n * Blood clotting defect. (abnormal PT and PTT)\n * Thromboembolic disease (history of deep vein thrombosis or pulmonary embolus)\n* Current or recent (within the past 3 months) use of the following medications:\n\n * Oral or systemic corticosteroids\n * Hormones: estrogens, progestins, oral contraceptives\n * Danazol, anticoagulants\n* Herbal or botanical supplements with possible hormonal effects.\n* Use within the past six months of the gonadotropin releasing hormones (GnRH) analogs or Depo-Provera.\n* Current or planned use during the study of any of the following medications/or products:\n\n * ketoconazole,\n * itraconazole,\n * erythromycin,\n * grapefruit juice,\n * rifampin,\n * St John's Wort,\n * phenytoin,\n * phenobarbital, or\n * carbamazepine"}, 'identificationModule': {'nctId': 'NCT00133705', 'briefTitle': 'Trial of Mifepristone for Fibroids', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Randomized Control Trial Of Mifepristone for Fibroids', 'orgStudyIdInfo': {'id': 'RO1-HD042578-2'}, 'secondaryIdInfos': [{'id': 'R01HD042578', 'link': 'https://reporter.nih.gov/quickSearch/R01HD042578', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mifepristone', 'description': 'Mifepristone 5 MG capsule taken once daily by mouth', 'interventionNames': ['Drug: Mifepristone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Inert capsule', 'description': 'Placebo (for Mifepristone) capsule of nearly identical color, size, and weight taken once daily by mouth', 'interventionNames': ['Drug: Inert Capsule']}], 'interventions': [{'name': 'Mifepristone', 'type': 'DRUG', 'otherNames': ['RU486'], 'description': 'Mifepristone 5mg/day by mouth for 6 months', 'armGroupLabels': ['Mifepristone']}, {'name': 'Inert Capsule', 'type': 'DRUG', 'description': 'sugar pill', 'armGroupLabels': ['Inert capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester School of Medicine & Dentistry', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Kevin Fiscella, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester School of Medicine & Dentistry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Tenured Professor', 'investigatorFullName': 'Kevin Fiscella', 'investigatorAffiliation': 'University of Rochester'}}}}