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)

Completed

• Conditions: Uterine Bleeding Profile Prediction
• Interventions: Device: MyIUS app

• Registration Number: NCT04989595
• Lead Sponsor: Bayer

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-07-20
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-04
• Study Start: 2021-09-17
• Primary Completion: 2024-01-06
• Study Completion: 2024-02-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3045

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women_Kyleena	MyIUS app	-
Women_Jaydess	MyIUS app	-
Women_Mirena	MyIUS app	-

Primary Outcome Measures

Name	Time	Method
Accuracy of the bleeding intensity prediction algorithm in predicting one out of three intensity clusters	Up to 270 days	Intensity clusters: bleeding, spotting, none

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Many Locations; 🇸🇪 Many Locations, Sweden