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) (MyIUS)

March 4, 2025 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

3045

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Many Locations, Brazil
        • Many Locations
  • Denmark
      • Many Locations, Denmark
        • Many Locations
  • Germany
      • Many Locations, Germany
        • Many Locations
  • Mexico
      • Many Locations, Mexico
        • Many Locations
  • Spain
      • Many Locations, Spain
        • Many Locations
  • Sweden
      • Many Locations, Sweden
        • Many Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women_Kyleena
Device: MyIUS app
Data will be self-reported by participants through the MyIUS app.
Women_Jaydess
Device: MyIUS app
Data will be self-reported by participants through the MyIUS app.
Women_Mirena
Device: MyIUS app
Data will be self-reported by participants through the MyIUS app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 270 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Accuracy of the menstrual cycle regularity prediction algorithm
Time Frame: Up to 270 days
Up to 270 days
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
Up to 270 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2021

Primary Completion (Actual)

January 6, 2024

Study Completion (Actual)

February 27, 2024

Study Registration Dates

First Submitted

July 20, 2021

First Submitted That Met QC Criteria

August 2, 2021

First Posted (Actual)

August 4, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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