Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
HMB-BD
1 other identifier
observational
300
1 country
9
Brief Summary
The goal of this multicenter prospective observational study and registry of U.S. adolescents and young adults with heritable bleeding disorders is to determine the bleeding outcomes, satisfaction, hemostatic parameter changes, and patient reported quality of life after 6 months of use of either of two commonly used hormonal treatments for menstrual suppression - levonorgestrel intrauterine device (LNG-IUD) and norethindrone acetate (NETA). Under this application the study will compare the two treatments and compare outcomes after LNG-IUD treatment results to a control group without a bleeding disorder, with the goal of determining the benefits and expected outcomes of these treatment options for this population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2025
Typical duration for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2023
CompletedFirst Posted
Study publicly available on registry
June 23, 2023
CompletedStudy Start
First participant enrolled
September 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
December 17, 2025
December 1, 2025
3.2 years
June 14, 2023
December 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment success rate
Proportion with pictorial blood loss assessment score \<50 points
6 months
Secondary Outcomes (6)
Median Pictorial Blood Assessment Chart (PBAC) score
6 months
Patient-reported treatment success rate
6 months
Change in Adolescent Menstrual Bleeding Questionnaire (aMBQ) score
Baseline to 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-25 or PROMIS-29) scores
Baseline to 6 months
Change in serum ferritin after treatment
Baseline to 6 months
- +1 more secondary outcomes
Study Arms (3)
Bleeding disorder using LNG-IUD
Adolescents and young adults ages 10-24 with diagnosed bleeding disorder planning use of LNG-IUD.
Non-bleeding disorder using LNG-IUD
Adolescents and young adults ages 10-24 without diagnosed bleeding disorder planning use of LNG-IUD.
Bleeding disorder using NETA
Adolescents and young adults ages 10-24 with diagnosed bleeding disorder planning use of NETA.
Interventions
52 mg levonorgestrel intrauterine system
norethindrone acetate 5 mg daily
Eligibility Criteria
Adolescents and young adults ages 10-24 with and without a heritable bleeding disorder who receive medical care for heavy menstrual bleeding at a participating U.S. clinical site. All clinical sites participate in a national consortium of interdisciplinary hematology-gynecology clinics.
You may qualify if:
- Post-menarcheal
- Ages 10-24
- Decision to initiate a trial of progestin therapy with either LNG-IUD or NETA
- Able to provide assent and written informed consent by one parent (ages \<18) or written informed consent (age 18+)
- Must meet trial criteria for heavy menstrual bleeding
- Must meet trial criteria for a bleeding disorder or have minimum workup to rule out bleeding disorder
You may not qualify if:
- Pregnant or seeking pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oregon Health and Science Universitylead
- University of Washingtoncollaborator
- NIH National Heart, Lung, and Blood Institutecollaborator
Study Sites (9)
Stanford
Palo Alto, California, 94304, United States
Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Emory
Atlanta, Georgia, 30322, United States
University of Michigan Medicine
Ann Arbor, Michigan, 48109, United States
Children's Mercy
Kansas City, Missouri, 64108, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Penn State Health
Hershey, Pennsylvania, 17003, United States
University of Washington
Seattle, Washington, 98101, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maureen Baldwin, MD MPH
Oregon Health and Science University
- PRINCIPAL INVESTIGATOR
Allison Wheeler
University of Washington
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Ob/Gyn
Study Record Dates
First Submitted
June 14, 2023
First Posted
June 23, 2023
Study Start
September 24, 2025
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
June 1, 2029
Last Updated
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Scientific data will be shared as soon as possible following study participant completion. Scientific data included in published manuscripts will be available at the time of publication; all other generated scientific data will be shared no later than the end of the award. The study data will be stored in the repository indefinitely, for at least 5 years.
- Access Criteria
- The study datasets will be collected with the following informed consent: The dataset can only be used for studying health, medical, or biomedical conditions and does not include the study of population origins or ancestry. We will also require all individuals requesting data to enter into a data sharing agreement that: 1) acknowledges the data will be stripped of identifying markers and identification; 2) acknowledges that these data will only be used for research purposes; and 3) requests investigators to reference the seminal publication describing data collection. The dataset can only be used for studying health, medical or biomedical conditions and does not include the study of population origins or ancestry. The requesting institution's IRB or equivalent body must approve the requested use.
This study will collect clinical, laboratory, and survey data from participants ages 10-24 at multiple academic clinical sites. Participant-level clinical data will be preserved through deposition of the data in a controlled access public repository. We will make our scientific data as widely and freely available as possible while safeguarding the privacy of participants (de-identified prior to repository submission) and protecting confidential and proprietary data.