Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-02-20 @ 1:43 PM
Study NCT ID:
NCT03074903
Status:
COMPLETED
Last Update Posted:
2018-02-13
First Post:
2017-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Skyla Insertion Timing Impact Bleeding?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-10-26', 'releaseDate': '2020-10-05'}], 'estimatedResultsFirstSubmitDate': '2020-10-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007434', 'term': 'Intrauterine Devices'}], 'ancestors': [{'id': 'D003274', 'term': 'Contraceptive Devices, Female'}, {'id': 'D003273', 'term': 'Contraceptive Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-12', 'studyFirstSubmitDate': '2017-02-06', 'studyFirstSubmitQcDate': '2017-03-03', 'lastUpdatePostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bleeding and spotting as collected by daily texts', 'timeFrame': '90 days', 'description': 'Composite variable of bleeding and spotting for 90 days after Skyla IUS insertion'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['intrauterine device', 'bleeding'], 'conditions': ['Vaginal Bleeding']}, 'referencesModule': {'references': [{'pmid': '30831104', 'type': 'DERIVED', 'citation': 'Shimoni N, Choudhury T, Goldman AR, Frondelli M, Chen PH. Bleeding and spotting with the levonorgestrel 13.5 mg intrauterine system: the impact of insertion timing. Contraception. 2019 Jun;99(6):340-344. doi: 10.1016/j.contraception.2019.02.004. Epub 2019 Mar 1.'}]}, 'descriptionModule': {'briefSummary': 'Women presenting for contraception will be offered the IUS Skyla and study participation. Daily bleeding will be collected for a total of 90 days and correlated with insertion timing and baseline endometrial thickness.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women presenting for intrauterine device insertion.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18-45\n* Parous or nulliparous\n* Desire Skyla for contraception\n* Regular menstrual cycles (21-35 days)\n* Working mobile phone and willing to accept text messages and report daily bleeding data for 90 days\n\nExclusion Criteria:\n\n* Vaginal or cesarean delivery in the past 12 weeks\n* Abortion in the past 6 weeks\n* Uterine anomaly distorting the uterus\n* Acute pelvic inflammatory disease\n* Uterine bleeding of unknown etiology\n* Acute liver disease or tumor\n* History of progestin-sensitive cancer\n* Abnormal pap smear awaiting diagnostic or therapeutic intervention'}, 'identificationModule': {'nctId': 'NCT03074903', 'briefTitle': 'Does Skyla Insertion Timing Impact Bleeding?', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Does Skyla Insertion Timing Impact Bleeding?', 'orgStudyIdInfo': {'id': 'Pro20150001449'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early cycle insertion', 'description': 'Participants in this group have the intrauterine system inserted during the first seven days of their menstrual cycle.', 'interventionNames': ['Device: Intrauterine system']}, {'label': 'Late cycle insertion', 'description': 'Participants in this group have the intrauterine system inserted during the remainder of their cycle.', 'interventionNames': ['Device: Intrauterine system']}], 'interventions': [{'name': 'Intrauterine system', 'type': 'DEVICE', 'otherNames': ['Intrauterine device'], 'description': 'Women having the Skyla intrauterine system at different times during their menstrual cycle report their bleeding patterns through daily texts.', 'armGroupLabels': ['Early cycle insertion', 'Late cycle insertion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Planned Parenthood', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'NJFPC', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'SHS', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}], 'overallOfficials': [{'name': "Noa'a Shimoni, MD MPH", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Family Medicine, NJMS', 'investigatorFullName': 'Noaa Shimoni', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-10-05', 'type': 'RELEASE'}, {'date': '2020-10-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Noaa Shimoni, Assistant Professor, Family Medicine, NJMS, Rutgers, The State University of New Jersey'}}}}