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)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04989595

Acronym

MyIUS

Enrollment

3045

Registered

2021-08-04

Start date

2021-09-17

Completion date

2024-02-27

Last updated

2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Bleeding Profile Prediction

Keywords

Prevention of pregnancy

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.

Interventions

DEVICEMyIUS app

Data will be self-reported by participants through the MyIUS app.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	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

Countries

Brazil, Denmark, Germany, Mexico, Spain, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026