Heavy Menstrual BleedingChampion-HMBNCT05176496
A Study Called Champion-HMB to Learn More About Females With Heavy Menstrual Bleeding and Available Treatments to Enable Earlier Diagnosis and to Predict Courses of Treatment
An observational study of Heavy Menstrual Bleeding, run by Bayer at 1 site in Germany.
Trial summary
This is an observational study in which patient data from the past of females with heavy menstrual bleeding (HMB) is studied. HMB describes menstrual periods with abnormally heavy or prolonged bleeding. Women concerned may not be able to maintain their usual activities during their period. Read more about this study
- Who is it for?
- Ages 11 to 55 years, women only
- Conditions the study is for
- Heavy Menstrual Bleeding
- How many people
- 99,999 participants
- Where
- 1 siteGermany
- Study dates
- 30 Nov 2021to 15 Jul 2023
- 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 11 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The study population includes 11 to 55-year-old women diagnosed with HMB in France, Germany, UK and US from 2000 to 2020.
Who may be able to join
- Cohort 1:
- Women may enter the cohort if they are between 11 and 55 years old and have a continuous observation of 365 days after the start of the observation period (from January 1, 2000 to December 31, 2020). Cohort entry events are limited to the earliest event per person.
- Entry events having no procedure occurrences of hysterectomy, starting anytime on or before cohort entry start date.
- Entry events having no condition occurrences of natural or iatrogenic menopause, starting anytime on or before cohort entry start date.
- Cohort 2:
- Women between 11 and 55 years old with continuous observation of 365 days before event may enter the cohort when observing a condition occurrence of HMB for the first time in the person's history; starting between January 1st, 2000 and December 31st, 2020. Cohort entry events are limited to the earliest event per person.
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- Entry events having no procedure occurrences of hysterectomy, starting anytime on or before cohort entry start date.
- Entry events having no condition occurrences of natural or iatrogenic menopause, starting anytime on or before cohort entry start date.
- Entry events having no condition occurrences of gynaecological bleeding other than HMB, starting anytime on or before cohort entry start date.
- Cohort 3:
- The cohort entry events, index date, and exit events are identical to those defined for cohort 2. Inclusion criteria is as defined for cohort 2, plus adding entry events having no condition occurrences of underlying causes of HMB, listed in 9.2.4.2 Underlying causes of HMB and including polyps, adenomyosis, leiomyoma, malignancy and endometrial hyperplasia, coagulopathy or iatrogenic HMB, starting anytime before or after cohort entry start date.
- Cohort 4:
- The cohort entry events, index date, and exit events are identical to those defined for cohort 2. Inclusion criteria is defined as for cohort 2, plus adding entry events having a prescription for LNGIUD or a procedure occurrence of LNG-IUD placement, starting anytime after cohort entry start date.
- Cohort 5:
- The cohort entry events, index date, and exit events are identical to those defined for cohort 2. Inclusion criteria is defined as for cohort 2, plus adding entry events receiving a prescription for, or a procedure occurrence of a guideline treatment (e.g. a prescription for LNG-IUD or a procedure occurrence of LNG-IUD placement), starting anytime after cohort entry start date.
- Cohort 6:
- The cohort entry events, index date, and exit events are identical to those defined for cohort 2. Inclusion criteria is defined as for cohort 2, plus adding entry events of not receiving a prescription for, or a procedure occurrence of a guideline treatment (e.g. a prescription for LNG-IUD or a procedure occurrence of LNG-IUD placement), starting anytime after cohort entry start date.
- Cohort 7:
- The cohort entry events, index date, and exit events are identical to those defined for cohort 2. Inclusion criteria is defined as for cohort 2, plus adding entry events of receiving a diagnosis of endometrial hyperplasia, or endometrial or cervical cancer anytime time prior to or after cohort entry start date.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization and Treatment Pathways of Heavy Menstrual Bleeding (HMB)
This is an observational study in which patient data from the past of females with heavy menstrual bleeding (HMB) is studied.
- HMB describes menstrual periods with abnormally heavy or prolonged bleeding. Women concerned may not be able to maintain their usual activities during their period. Thus, HMB can reduce the quality of life and may lead to other medical problems. It is described that up to 30 of 100 women ask doctors for help concerning HMB during their fertile years. HMB is often not recognized and treated timely. In addition, there is little information about characteristics of women with HMB and real-world data on available treatments are missing.
Read more
Despite the availability of non-invasive therapeutic options, for some women with severe HMB, surgical treatments (also called invasive) may be needed that can lead to infertility.
- In this study researchers want to learn more about:
- the percentage of women diagnosed with HMB
- characteristics of these women like age at diagnosis or medical problems
- treatment pathways of women with HMB in usual care
Regarding treatment pathways, the researchers are especially interested in:
- the percentage of women who use different therapeutic options over time
- the percentage of women receiving invasive treatment for HMB after they received treatment as recommended by guidelines versus those not treated as recommended
- To do this, researchers will collect information from five observational healthcare databases. Data will be from the year 2000 up to 2020.
- Besides this data collection, no further tests or examinations are planned in this study.
- In future, this information shall help to identify women with HMB and to learn what information may predict if invasive treatment will be needed later on.
- Conditions
- Heavy Menstrual Bleeding
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Women with a continuous observation of 365 days after January 1st, 2000 and before December 31, 2020. | |
| Cohort 2 | Women diagnosed with HMB. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rates of women diagnosed with HMB per year
Measured: Retrospective analysis from 2000 to 2020
Incidence rates of women diagnosed with HMB over the entire study period
Measured: Retrospective analysis from 2000 to 2020
Proportion of women receiving a diagnosis of HMB over the entire study period
Measured: Retrospective analysis from 2000 to 2020
Patient characteristics of women with a diagnosis of HMB
Characterize demographics, co-morbidities, co-medications, procedures.
Measured: Retrospective analysis from 2000 to 2020
Comorbidities of women with a diagnosis of HMB
Measured: Retrospective analysis from 2000 to 2020
Treatment pathways of multiple therapeutic options
Measured: Retrospective analysis from 2000 to 2020
Frequency of guideline-compliant treatment for HMB
Measured: Retrospective analysis from 2000 to 2020
Patient characteristics
Characterise women with guideline-compliant versus non-guideline compliant treatment.
Measured: Retrospective analysis from 2000 to 2020
Frequency/incidence of future invasive treatment
Characterise women with guideline-compliant versus non-guideline compliant treatment.
Measured: Retrospective analysis from 2000 to 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start30 Nov 2021
- Primary completion15 Jul 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy Menstrual BleedingStudies 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
- Retrospective
- Enrolment
- 99,999 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176496
- Sponsor's protocol ID
- 22061
- Acronym
- Champion-HMB
- Status last verified
- Jul 2023
- First submitted
- 15 Dec 2021
- Last updated
- 27 Jul 2023
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Treatment Pathways of Heavy Menstrual Bleeding (HMB)
- ClinicalTrials.gov ID
- NCT05176496
- Acronym / sponsor ID
- Champion-HMB / 22061
- Conditions
- Heavy Menstrual Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99,999 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 4 Jan 2022 (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.
This is an observational study in which patient data from the past of females with heavy menstrual bleeding (HMB) is studied.
- HMB describes menstrual periods with abnormally heavy or prolonged bleeding. Women concerned may not be able to maintain their usual activities during their period. Thus, HMB can reduce the quality of life and may lead to other medical problems. It is described that up to 30 of 100 women ask doctors for help concerning HMB during their fertile years. HMB is often not recognized and treated timely. In addition, there is little information about characteristics of women with HMB and real-world data on available treatments are missing.
Despite the availability of non-invasive therapeutic options, for some women with severe HMB, surgical treatments (also called invasive) may be needed that can lead to infertility.
- In this study researchers want to learn more about:
- the percentage of women diagnosed with HMB
- characteristics of these women like age at diagnosis or medical problems
- treatment pathways of women with HMB in usual care
Regarding treatment pathways, the researchers are especially interested in:
- the percentage of women who use different therapeutic options over time
- the percentage of women receiving invasive treatment for HMB after they received treatment as recommended by guidelines versus those not treated as recommended
- To do this, researchers will collect information from five observational healthcare databases. Data will be from the year 2000 up to 2020.
- Besides this data collection, no further tests or examinations are planned in this study.
- In future, this information shall help to identify women with HMB and to learn what information may predict if invasive treatment will be needed later on.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Women with a continuous observation of 365 days after January 1st, 2000 and before December 31, 2020. |
| Cohort 2 | – | –Women diagnosed with HMB. |
Who may qualify
- Ages
- 11 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population includes 11 to 55-year-old women diagnosed with HMB in France, Germany, UK and US from 2000 to 2020.
Key inclusion criteria (19 listed)
- Women may enter the cohort if they are between 11 and 55 years old and have a continuous observation of 365 days after the start of the observation period (from January 1, 2000 to December 31, 2020). Cohort entry events are limited to the earliest event per person.
- Entry events having no procedure occurrences of hysterectomy, starting anytime on or before cohort entry start date.
- Entry events having no condition occurrences of natural or iatrogenic menopause, starting anytime on or before cohort entry start date.
- Women between 11 and 55 years old with continuous observation of 365 days before event may enter the cohort when observing a condition occurrence of HMB for the first time in the person's history; starting between January 1st, 2000 and December 31st, 2020. Cohort entry events are limited to the earliest event per person.
- Entry events having no procedure occurrences of hysterectomy, starting anytime on or before cohort entry start date.
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.
Primary outcome
Incidence rates of women diagnosed with HMB per year
Time frame: Retrospective analysis from 2000 to 2020
Incidence rates of women diagnosed with HMB over the entire study period
Time frame: Retrospective analysis from 2000 to 2020
Proportion of women receiving a diagnosis of HMB over the entire study period
Time frame: Retrospective analysis from 2000 to 2020
Patient characteristics of women with a diagnosis of HMB
Time frame: Retrospective analysis from 2000 to 2020
Characterize demographics, co-morbidities, co-medications, procedures.
Comorbidities of women with a diagnosis of HMB
Time frame: Retrospective analysis from 2000 to 2020
Treatment pathways of multiple therapeutic options
Time frame: Retrospective analysis from 2000 to 2020
Frequency of guideline-compliant treatment for HMB
Time frame: Retrospective analysis from 2000 to 2020
Patient characteristics
Time frame: Retrospective analysis from 2000 to 2020
Characterise women with guideline-compliant versus non-guideline compliant treatment.
Frequency/incidence of future invasive treatment
Time frame: Retrospective analysis from 2000 to 2020
Characterise women with guideline-compliant versus non-guideline compliant treatment.
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 27 Jul 2023.
- 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heavy Menstrual Bleeding, run by Bayer at 1 site in Germany.
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 19 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Incidence rates of women diagnosed with HMB per year (time frame: Retrospective analysis from 2000 to 2020). The study lists 9 primary outcomes in all. 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 27 Jul 2023.