Uterine Bleeding Profile PredictionMyIUSNCT04989595
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)
An observational study of Uterine Bleeding Profile Prediction, run by Bayer at 6 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Bleeding Profile Prediction
- What is being tested?
- MyIUS app
- Type of treatment
- Medical device
- How many people
- 3,045 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 17 Sep 2021to 27 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Uterine Bleeding Profile Prediction
- Being tested
- MyIUS app
- Keywords
- Prevention of pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyIUS appDevice
Data will be self-reported by participants through the MyIUS app.
| Study group | Role | What they receive |
|---|---|---|
| Women_Kyleena | Not described Receives: Device: MyIUS app | |
| Women_Jaydess | Not described Receives: Device: MyIUS app | |
| Women_Mirena | Not described Receives: Device: MyIUS app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the bleeding intensity prediction algorithm in predicting one out of three intensity clusters
Intensity clusters: bleeding, spotting, none
Measured: Up to 270 days
Secondary outcomes (2)
Accuracy of the menstrual cycle regularity prediction algorithm
Measured: Up to 270 days
Difference in accuracy of the original prediction algorithm compared to the adapted algorithm on the collected real-world data
Measured: Up to 270 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start17 Sep 2021
- Primary completion6 Jan 2024
- Study completion27 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Bleeding Profile PredictionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,045 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989595
- Sponsor's protocol ID
- 21424
- Acronym
- MyIUS
- Status last verified
- Mar 2025
- First submitted
- 20 Jul 2021
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Performance Study Testing an Algorithm to Predict the Future Bleeding Profile of Women After Insertion of Intrauterine Systems for Contraception
- ClinicalTrials.gov ID
- NCT04989595
- Acronym / sponsor ID
- MyIUS / 21424
- Conditions
- Uterine Bleeding Profile Prediction
- Keywords
- Prevention of pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,045 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 6 Jan 2024 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Women_Kyleena | – | Device: MyIUS app |
| Women_Jaydess | – | Device: MyIUS app |
| Women_Mirena | – | Device: MyIUS app |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyIUS appData will be self-reported by participants through the MyIUS app. | Device | Women_Jaydess, Women_Kyleena, Women_Mirena |
Primary outcome
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
2 secondary outcomes
Accuracy of the menstrual cycle regularity prediction algorithm
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Bleeding Profile Prediction, run by Bayer at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil, Denmark, Germany, Mexico, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the bleeding intensity prediction algorithm in predicting one out of three intensity clusters (time frame: Up to 270 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.