Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-25 @ 12:37 PM
Study NCT ID:
NCT04989595
Status:
COMPLETED
Last Update Posted:
2025-03-06
First Post:
2021-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Learn More About How a Smartphone App Called MyIUS Predicts Future Menstrual Bleeding in Women After They Have Begun Using Intrauterine Birth Control Method (a Birth Control Device is Inserted Into a Woman's Uterus by Her Doctor)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France', 'Portugal', 'United Kingdom']}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3045}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2021-07-20', 'studyFirstSubmitQcDate': '2021-08-02', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of the bleeding intensity prediction algorithm in predicting one out of three intensity clusters', 'timeFrame': 'Up to 270 days', 'description': 'Intensity clusters: bleeding, spotting, none'}], 'secondaryOutcomes': [{'measure': 'Accuracy of the menstrual cycle regularity prediction algorithm', 'timeFrame': 'Up to 270 days'}, {'measure': 'Difference in accuracy of the original prediction algorithm compared to the adapted algorithm on the collected real-world data', 'timeFrame': 'Up to 270 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prevention of pregnancy'], 'conditions': ['Uterine Bleeding Profile Prediction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/', 'label': "Click here for access to information about Bayer's transparency standards and Bayer studies."}]}, 'descriptionModule': {'briefSummary': 'Researchers are looking to learn more about future menstrual bleeding in women who have started using intrauterine contraception methods. "Intrauterine contraception" means that a device is inserted into a woman\'s uterus by her doctor. The device then releases a birth control treatment into the uterus.\n\nResearchers have found that when women use intrauterine contraception, its effects on the menstrual cycle can cause changes to how often and for how long women will bleed. This is one of reasons women may stop using their intrauterine contraception.\n\nSo, the researchers in this study wanted to learn about a tool that can be used to predict future bleeding events. This tool was developed based on the results of previous clinical studies that researched menstrual bleeding. This tool is a smartphone application called MyIUS.\n\nThis study will include about 3,000 women who have recently had intrauterine contraception inserted and who use the MyIUS app.\n\nThere will be no visits with a study doctor in this study. After the intrauterine contraception has been inserted, the women will start to record any events of bleeding in the MyIUS app. After they have recorded events of bleeding for a total of 90 days, the MyIUS app will give a prediction of menstrual bleeding expected for the next 180 days. The women who sign the electronic informed consent form will continue to record their bleeding events for a total of 6 months.\n\nThe researchers will then collect this information. They will use this information to find out how well the MyIUS app can predict future menstrual bleeding.', 'detailedDescription': 'The aim of this study is to demonstrate that the bleeding prediction algorithm which was developed and validated based on clinical trial data also works in a real-world setting.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women (of legal age to provide electronic informed consent (eIC)) after insertion of Kyleena, Jaydess, or Mirena who use medical device software (MyIUS app) for bleeding profile prediction at day 90.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Insertion of Kyleena, Jaydess, or Mirena IUS\n* Female (of legal age to provide electronic informed consent (eIC)) using the MyIUS app\n* Submitted eIC to use all data documented in the MyIUS app\n\nExclusion Criteria:\n\n\\- None'}, 'identificationModule': {'nctId': 'NCT04989595', 'acronym': 'MyIUS', 'briefTitle': "A Study to Learn More About How a Smartphone App Called MyIUS Predicts Future Menstrual Bleeding in Women After They Have Begun Using Intrauterine Birth Control Method (a Birth Control Device is Inserted Into a Woman's Uterus by Her Doctor)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Real-world Performance Study Testing an Algorithm to Predict the Future Bleeding Profile of Women After Insertion of Intrauterine Systems for Contraception', 'orgStudyIdInfo': {'id': '21424'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women_Kyleena', 'interventionNames': ['Device: MyIUS app']}, {'label': 'Women_Jaydess', 'interventionNames': ['Device: MyIUS app']}, {'label': 'Women_Mirena', 'interventionNames': ['Device: MyIUS app']}], 'interventions': [{'name': 'MyIUS app', 'type': 'DEVICE', 'description': 'Data will be self-reported by participants through the MyIUS app.', 'armGroupLabels': ['Women_Jaydess', 'Women_Kyleena', 'Women_Mirena']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'Brazil', 'facility': 'Many Locations'}, {'city': 'Many Locations', 'country': 'Denmark', 'facility': 'Many Locations'}, {'city': 'Many Locations', 'country': 'Germany', 'facility': 'Many Locations'}, {'city': 'Many Locations', 'country': 'Mexico', 'facility': 'Many Locations'}, {'city': 'Many Locations', 'country': 'Spain', 'facility': 'Many Locations'}, {'city': 'Many Locations', 'country': 'Sweden', 'facility': 'Many Locations'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Availability of this study\'s data will later be determined according to Bayer\'s commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}