Clinical trial 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)
Official title: Real-world Performance Study Testing an Algorithm to Predict the Future Bleeding Profile of Women After Insertion of Intrauterine Systems for Contraception
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Bleeding Profile Prediction
Keywords: Prevention of pregnancy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2021-08-04
Enrollment: 3045
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of the bleeding intensity prediction algorithm in predicting one out of three intensity clusters
timeFrame: Up to 270 days
Secondary outcomes:
measure: Accuracy of the menstrual cycle regularity prediction algorithm
timeFrame: Up to 270 days
measure: Difference in accuracy of the original prediction algorithm compared to the adapted algorithm on the collected real-world data
timeFrame: Up to 270 days
Other outcomes:
Locations:
city: Many Locations
country: Brazil
facility: Many Locations
city: Many Locations
country: Denmark
facility: Many Locations
city: Many Locations
country: Germany
facility: Many Locations
city: Many Locations
country: Mexico
facility: Many Locations
city: Many Locations
country: Spain
facility: Many Locations
city: Many Locations
country: Sweden
facility: Many Locations
Study officials:
References: