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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women_Kyleena |
| ||
| Women_Jaydess |
| ||
| Women_Mirena |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyIUS app | Device | Data will be self-reported by participants through the MyIUS app. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of the bleeding intensity prediction algorithm in predicting one out of three intensity clusters | Intensity clusters: bleeding, spotting, none | Up to 270 days |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of the menstrual cycle regularity prediction algorithm | Up to 270 days | |
| Difference in accuracy of the original prediction algorithm compared to the adapted algorithm on the collected real-world data | Up to 270 days |
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Inclusion Criteria:
Exclusion Criteria:
- None
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Many Locations | Brazil | ||||
| Many Locations |
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.
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| Many Locations |
| Denmark |
| Many Locations | Many Locations | Germany |
| Many Locations | Many Locations | Mexico |
| Many Locations | Many Locations | Spain |
| Many Locations | Many Locations | Sweden |