check_circleStudy Completed
Uterine bleeding profile prediction
Bayer Identifier:
21424
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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)
Trial purpose
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.
Researchers 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.
So, 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.
This study will include about 3,000 women who have recently had intrauterine contraception inserted and who use the MyIUS app.
There 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.
The researchers will then collect this information. They will use this information to find out how well the MyIUS app can predict future menstrual bleeding.
Researchers 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.
So, 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.
This study will include about 3,000 women who have recently had intrauterine contraception inserted and who use the MyIUS app.
There 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.
The researchers will then collect this information. They will use this information to find out how well the MyIUS app can predict future menstrual bleeding.
Key Participants Requirements
Sex
FemaleAge
NaN - N/ATrial summary
Enrollment Goal
3045Trial Dates
September 2021 - February 2024Phase
Phase 4Could I Receive a placebo
NoProducts
Kyleena (Levonorgestrel, BAY86-5028)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations | Many Locations, Denmark |
Completed | Many Locations | Many Locations, Sweden |
Completed | Many Locations | Many Locations, Germany |
Completed | Many Locations | Many Locations, Spain |
Completed | Many Locations | Many Locations, Mexico |
Completed | Many Locations | Many Locations, Brazil |
Withdrawn | Many Locations | Many Locations, France |
Withdrawn | Many Locations | Many Locations, United Kingdom |
Withdrawn | Many Locations | Many Locations, Portugal |
Primary Outcome
- Accuracy of the bleeding intensity prediction algorithm in predicting one out of three intensity clustersIntensity clusters: bleeding, spotting, nonedate_rangeTime Frame:Up to 270 days
Secondary Outcome
- Accuracy of the menstrual cycle regularity prediction algorithmdate_rangeTime Frame:Up to 270 days
- Difference in accuracy of the original prediction algorithm compared to the adapted algorithm on the collected real-world datadate_rangeTime Frame:Up to 270 days
Trial design
Trial Type
ObservationalIntervention Type
DeviceTrial Purpose
PreventionAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A