check_circleStudy Completed

Uterine bleeding profile prediction

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)

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

NaN - N/A
  • - 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
  • - None

Trial summary

Enrollment Goal
3045
Trial Dates
September 2021 - February 2024
Phase
Phase 4
Could I Receive a placebo
No
Products
Kyleena (Levonorgestrel, BAY86-5028)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Denmark
Completed
Many LocationsMany Locations, Sweden
Completed
Many LocationsMany Locations, Germany
Completed
Many LocationsMany Locations, Spain
Completed
Many LocationsMany Locations, Mexico
Completed
Many LocationsMany Locations, Brazil
Withdrawn
Many LocationsMany Locations, France
Withdrawn
Many LocationsMany Locations, United Kingdom
Withdrawn
Many LocationsMany Locations, Portugal

Primary Outcome

  • Accuracy of the bleeding intensity prediction algorithm in predicting one out of three intensity clusters
    Intensity clusters: bleeding, spotting, none
    date_rangeTime Frame:
    Up to 270 days

Secondary Outcome

  • Accuracy of the menstrual cycle regularity prediction algorithm
    date_rangeTime Frame:
    Up to 270 days
  • Difference in accuracy of the original prediction algorithm compared to the adapted algorithm on the collected real-world data
    date_rangeTime Frame:
    Up to 270 days

Trial design

Real-world performance study testing an algorithm to predict the future bleeding profile of women after insertion of intrauterine systems for contraception
Trial Type
Observational
Intervention Type
Device
Trial Purpose
Prevention
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A