Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-02-25 @ 6:53 PM
Study NCT ID:
NCT03972358
Status:
UNKNOWN
Last Update Posted:
2021-03-24
First Post:
2019-05-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Medical Menstrual Regulation in the United States
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 284}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-22', 'studyFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2019-05-31', 'lastUpdatePostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who report that MMR was acceptable or highly acceptable during the exit interview', 'timeFrame': 'Up to 28 days after mifepristone administration', 'description': 'Acceptability of MMR'}], 'secondaryOutcomes': [{'measure': 'Number of participants not pregnant at follow-up', 'timeFrame': 'Up to 28 days after mifepristone administration', 'description': 'Efficacy'}, {'measure': 'Number of participants with adverse events and/or side effects', 'timeFrame': 'Up to 28 days after mifepristone administration', 'description': 'Safety and side effects'}, {'measure': 'Perceived advantages and disadvantages of MMR as reported by participants during the exit interview', 'timeFrame': 'Up to 28 days after mifepristone administration', 'description': 'Experiences, perceived advantages and disadvantages'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Menstrual Regulation']}, 'descriptionModule': {'briefSummary': 'This study will assess the acceptability and use of medical menstrual regulation among women in the United States.', 'detailedDescription': 'Medical menstrual regulation (MMR) entails the use of uterine evacuation medications by women with late menses without confirming pregnancy status. Provision of MMR in the United States could expand reproductive choice and service options for women. This study will collect data on the acceptability, efficacy, safety and feasibility of MMR among women with missed menses of 1-21 days'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-49 years\n2. General good health\n3. Does not want to be pregnant\n4. Does not want to verify pregnancy status at the study site\n5. History of regular monthly menstrual cycles\n6. Missed menses of 1-21 days\n7. Sexual activity in the past 2 months\n8. Willing and able to sign consent forms\n9. Willing to provide urine sample at enrollment\n10. Willing to return for a follow-up visit\n\nExclusion Criteria:\n\n1. Known allergies or contraindications to mifepristone and/or misoprostol\n2. Symptoms of or risk factors for ectopic pregnancy\n3. Current use of an IUD, contraceptive implant or injectable'}, 'identificationModule': {'nctId': 'NCT03972358', 'briefTitle': 'Assessing Medical Menstrual Regulation in the United States', 'organization': {'class': 'OTHER', 'fullName': 'Gynuity Health Projects'}, 'officialTitle': 'Assessing Acceptability and Use of Medical Menstrual Regulation in the United States', 'orgStudyIdInfo': {'id': '8002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medical menstrual regulation', 'description': 'Mifepristone 200 mg orally on day 1.\n\nMisoprostol 800 mcg buccally on day 2 (24 hours after mifepristone).', 'interventionNames': ['Drug: Mifepristone', 'Drug: Misoprostol']}], 'interventions': [{'name': 'Mifepristone', 'type': 'DRUG', 'description': 'All participants will receive 200 mg mifepristone, to be taken orally on day 1.', 'armGroupLabels': ['Medical menstrual regulation']}, {'name': 'Misoprostol', 'type': 'DRUG', 'description': 'All participants will receive 800 mcg misoprostol, to be taken buccally 24 hours after mifepristone (day 2)', 'armGroupLabels': ['Medical menstrual regulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60076', 'city': 'Skokie', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melissa Grant', 'role': 'CONTACT', 'phone': '855-729-2272'}, {'name': 'Melissa Grant', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carafem Health Center', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melissa Grant', 'role': 'CONTACT', 'phone': '855-729-2272'}, {'name': 'Melissa Grant', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carafem Health Center', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}], 'centralContacts': [{'name': 'Wendy R Sheldon, PhD', 'role': 'CONTACT', 'email': 'wsheldon@gynuity.org', 'phone': '212-448-1230'}], 'overallOfficials': [{'name': 'Wendy R Sheldon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynuity Health Projects'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Sharing de-identified data will be considered upon individual request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynuity Health Projects', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}