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 (Champion-HMB)

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.

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 Overview

• Status: Completed
• Conditions: Heavy Menstrual Bleeding

• Study Type: Observational
• Enrollment (Actual): 99999

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13342
    • Bayer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): July 15, 2023

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Menstruation Disturbances; Uterine Hemorrhage; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Hemorrhage; Menorrhagia
• Other Study ID Numbers: 22061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No