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)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Real-world Performance Study Testing an Algorithm to Predict the Future Bleeding Profile of Women After Insertion of Intrauterine Systems for Contraception

Conditions
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Uterine Bleeding Profile Prediction

Intervention / Treatment
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* Device: MyIUS app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Insertion of Kyleena, Jaydess, or Mirena IUS Female (of legal age to provide electronic informed consent (eIC)) using the MyIUS app Submitted eIC to use all data documented in the MyIUS app Exclusion Criteria: - None
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women_Kyleena<br> | Device: MyIUS app<br>* Data will be self-reported by participants through the MyIUS app.<br>|
| Women_Jaydess<br> | Device: MyIUS app<br>* Data will be self-reported by participants through the MyIUS app.<br>|
| Women_Mirena<br> | Device: MyIUS app<br>* Data will be self-reported by participants through the MyIUS app.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding intensity prediction algorithm |  | At day 90 | 
| Documented bleeding patterns (bleeding, spotting, none) |  | Up to 270 days | 
| Date for each bleeding pattern entered |  | Up to 270 days | 
| Baseline characteristics | Includes: Age Country Weight Height Pregnancy (number of) Birth (number of) Prior contraceptive methods Barrier methods, Implants, Intrauterine device (IUD), IUS, Oral hormonal contraception Other, None IUS type (Mirena, Jaydess, Kyleena) Insertion date | At day 1 | 
| IUS type (Mirena, Jaydess, Kyleena) |  | At day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menstrual cycle regularity prediction algorithm |  | At day 90 | 
| Menstrual cycle regularity derived from documented bleeding patterns |  | Up to 270 days | 
| The difference in accuracy of the original prediction algorithm compared to the adapted algorithm on the collected real-world data |  | Up to 270 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention of pregnancy