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Completed

NCT Number: 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

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.

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Key information

Conditions

Heavy Menstrual Bleeding Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menorrhagia Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

11 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Bayer

Berlin, 13342, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence rates of women diagnosed with HMB per year

    Time frame: Retrospective analysis from 2000 to 2020

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

    Time frame: Retrospective analysis from 2000 to 2020

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

    Time frame: Retrospective analysis from 2000 to 2020

  4. Patient characteristics of women with a diagnosis of HMB

    Time frame: Retrospective analysis from 2000 to 2020

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

  5. Comorbidities of women with a diagnosis of HMB

    Time frame: Retrospective analysis from 2000 to 2020

  6. Treatment pathways of multiple therapeutic options

    Time frame: Retrospective analysis from 2000 to 2020

  7. Frequency of guideline-compliant treatment for HMB

    Time frame: Retrospective analysis from 2000 to 2020

  8. Patient characteristics

    Time frame: Retrospective analysis from 2000 to 2020

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

  9. Frequency/incidence of future invasive treatment

    Time frame: Retrospective analysis from 2000 to 2020

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Characterization and Treatment Pathways of Heavy Menstrual Bleeding (HMB)

Acronym: Champion-HMB

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 4, 2022
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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