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

NCT05176496 | Completed

• 1 other identifier: 22061
• Study Type: observational
• Target: 99,999
• Locations: 1 country
• Sites: 1

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.

Conditions

Heavy Menstrual Bleeding

Outcome Measures

Primary Outcomes (9)

• Incidence rates of women diagnosed with HMB per year

  Retrospective analysis from 2000 to 2020

• Incidence rates of women diagnosed with HMB over the entire study period

  Retrospective analysis from 2000 to 2020

• Proportion of women receiving a diagnosis of HMB over the entire study period

  Retrospective analysis from 2000 to 2020

• Patient characteristics of women with a diagnosis of HMB

  Characterize demographics, co-morbidities, co-medications, procedures.

  Retrospective analysis from 2000 to 2020

• Comorbidities of women with a diagnosis of HMB

  Retrospective analysis from 2000 to 2020

• Treatment pathways of multiple therapeutic options

  Retrospective analysis from 2000 to 2020

• Frequency of guideline-compliant treatment for HMB

  Retrospective analysis from 2000 to 2020

• Patient characteristics

  Characterise women with guideline-compliant versus non-guideline compliant treatment.

  Retrospective analysis from 2000 to 2020

• Frequency/incidence of future invasive treatment

  Characterise women with guideline-compliant versus non-guideline compliant treatment.

  Retrospective analysis from 2000 to 2020

Study Arms (2)

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.

Eligibility Criteria

• Age: 11 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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:
• Cohort 4:
• Cohort 5:
• Cohort 6:
• Cohort 7:

You may not qualify if:

• \- None.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Bayer

Berlin, 13342, Germany

Location

MeSH Terms

Conditions

Menorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 4, 2022
• Study Start: November 30, 2021
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)