Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-24 @ 1:42 PM
Study NCT ID:
NCT04989595
Status:
COMPLETED
Last Update Posted:
2025-03-06
First Post:
2021-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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)
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
Real-world Performance Study Testing an Algorithm to Predict the Future Bleeding Profile of Women After Insertion of Intrauterine Systems for Contraception
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MyIUS
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: