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OpenTrials
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NCT Number: NCT04989595

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)

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MyIUS app

Device

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

Primary outcomes

  1. Accuracy of the bleeding intensity prediction algorithm in predicting one out of three intensity clusters

    Time frame: Up to 270 days

    Intensity clusters: bleeding, spotting, none

Secondary outcomes

  1. Accuracy of the menstrual cycle regularity prediction algorithm

    Time frame: Up to 270 days

  2. Difference in accuracy of the original prediction algorithm compared to the adapted algorithm on the collected real-world data

    Time frame: Up to 270 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: MyIUS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 4, 2021
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.