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

Characterization and Treatment Pathways of Heavy Menstrual Bleeding (HMB)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 99,999 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 11 Years – 55 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2021-11-30
• Primary completion: 2023-07-15
• Completion: 2023-07-15
• First posted: 2022-01-04
• Last updated: 2023-07-27

Locations

1 site across 1 country: Germany