Clinical trial NCT05176496: 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
Official title: Characterization and Treatment Pathways of Heavy Menstrual Bleeding (HMB)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heavy Menstrual Bleeding
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2022-01-04
Enrollment: 99999
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

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.
* 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.

Exclusion Criteria:

- None.

Primary outcomes:
measure: Incidence rates of women diagnosed with HMB per year
timeFrame: Retrospective analysis from 2000 to 2020
measure: Incidence rates of women diagnosed with HMB over the entire study period
timeFrame: Retrospective analysis from 2000 to 2020
measure: Proportion of women receiving a diagnosis of HMB over the entire study period
timeFrame: Retrospective analysis from 2000 to 2020
measure: Patient characteristics of women with a diagnosis of HMB
timeFrame: Retrospective analysis from 2000 to 2020
measure: Comorbidities of women with a diagnosis of HMB
timeFrame: Retrospective analysis from 2000 to 2020
measure: Treatment pathways of multiple therapeutic options
timeFrame: Retrospective analysis from 2000 to 2020
measure: Frequency of guideline-compliant treatment for HMB
timeFrame: Retrospective analysis from 2000 to 2020
measure: Patient characteristics
timeFrame: Retrospective analysis from 2000 to 2020
measure: Frequency/incidence of future invasive treatment
timeFrame: Retrospective analysis from 2000 to 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Bayer
Study officials:
References: