Heavy Menstrual BleedingHMB-BDNCT05916469
Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
An observational study of Heavy Menstrual Bleeding and Bleeding Disorder, run by Oregon Health and Science University at 9 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 24 years, women only
- Conditions the study is for
- Heavy Menstrual Bleeding, Bleeding Disorder, Von Willebrand Diseases
- What is being tested?
- Levonorgestrel Intrauterine System and Norethindrone Acetate
- How many people
- 300 participants
- Where
- 9 sitesUnited States
- Study dates
- 24 Sep 2025to Jun 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 24 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Pregnant or seeking pregnancy
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Not yet recruiting
University of Michigan Medicine
Ann Arbor, Michigan, 48109
- Not yet recruiting
Emory
Atlanta, Georgia, 30322
- Not yet recruiting
Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
- Not yet recruiting
Penn State Health
Hershey, Pennsylvania, 17003
- Not yet recruiting
Children's Mercy
Kansas City, Missouri, 64108
- Not yet recruiting
Stanford
Palo Alto, California, 94304
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Women's Health Research Unit, 503-494-3666, whru@ohsu.edu
- Not yet recruiting
University of Washington
Seattle, Washington, 98101
Washington Center for Bleeding Disorders, 206-614-1200, WICResearch@WACBD.org
- Not yet recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
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.
Read the detailed description
Heavy menstrual bleeding (HMB) is common among adolescents and young adults with an inherited bleeding disorder (BD) and negatively impacts health-related quality of life and physical and mental health status. Effective treatment options are available that decrease bleeding and improve quality of life, but were not studied in those with BD, so investigators do not know if there is similar effectiveness in this condition. The impact of treatment on diagnostic testing for BD or on improvement of iron deficiency is also not known. Given these gaps in knowledge, the primary objective of the Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study is to conduct a multicenter prospective observational cohort study and registry, enrolling adolescents and young adults with heavy menstrual bleeding cared for at collaborating interdisciplinary menstrual clinic sites nationally who are choosing to start use of either of two commonly used progestin menstrual treatment options: levonorgestrel-releasing intrauterine system (LNG-IUD) or oral norethindrone acetate 5 mg daily (NETA) (N=300). In Aim 1, the study will compare outcomes related to (a) bleeding management, (b) quality of life, and (c) repletion of iron storage levels after six months of treatment with either option in those with a diagnosed inherited bleeding disorder. The primary outcome will be treatment success with a Pictorial Blood Loss Assessment Chart (PBAC) score <50 points by six months. Secondary objectives to assess bleeding management will include need for adjuvant management, change in PBAC from baseline to 6 months, and self-reported treatment success. Quality of life outcomes will include change in validated scales to assess health-related quality of life which are specific to adolescents and young adults in the setting of heavy menstrual bleeding. The study will compare ferritin levels at six months compared to baseline to determine the relative amount of benefit obtained from either treatment option. In Aim 2, the study will compare outcomes after LNG-IUD in those with and without a bleeding disorder, assessing rates of expulsion and method continuation between the two groups in addition to the outcomes assessed for Aim 1. Aim 3 will improve our understanding of the impact of physiological stress on BD diagnostic studies by comparing change in hemostatic parameters before and after successful treatment in those with HMB without a previously diagnosed bleeding disorder. This study will demonstrate the relative benefits of menstrual suppression treatment options for adolescents and young adults with heavy menstrual bleeding and inherited bleeding disorders, will provide population-specific estimates for expected benefit that can be used in treatment counseling, and will highlight the impact of treatment status on diagnostic test results.
- Being tested
- Levonorgestrel Intrauterine System, Norethindrone Acetate
- Medical subject headings
- Menorrhagia, Hemostatic Disorders, von Willebrand Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel Intrauterine SystemDrug
Also called Mirena, Liletta
52 mg levonorgestrel intrauterine system
Norethindrone AcetateDrug
Also called Aygestin
norethindrone acetate 5 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Bleeding disorder using LNG-IUD | Adolescents and young adults ages 10-24 with diagnosed bleeding disorder planning use of LNG-IUD. Receives: Drug: Levonorgestrel Intrauterine System | |
| Non-bleeding disorder using LNG-IUD | Adolescents and young adults ages 10-24 without diagnosed bleeding disorder planning use of LNG-IUD. Receives: Drug: Levonorgestrel Intrauterine System | |
| Bleeding disorder using NETA | Adolescents and young adults ages 10-24 with diagnosed bleeding disorder planning use of NETA. Receives: Drug: Norethindrone Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success rate
Proportion with pictorial blood loss assessment score <50 points
Measured: 6 months
Secondary outcomes (6)
Median Pictorial Blood Assessment Chart (PBAC) score
Group median of pictorial blood loss assessment score. PBAC scores start at 0 to represent no bleeding with higher PBAC scores representing heavy menstrual bleeding. There is no maximum PBAC score.
Measured: 6 months
Patient-reported treatment success rate
Proportion with patient-reported treatment success. Treatment success will be measured with Yes or No bivariate response.
Measured: 6 months
Change in Adolescent Menstrual Bleeding Questionnaire (aMBQ) score
Group median of individual change in adolescent menstrual bleeding questionnaire score. aMBQ scores can range from 0 to 77 with higher scores representing worse health-related quality of life.
Measured: Baseline to 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-25 or PROMIS-29) scores
Group median of individual change in patient-reported outcomes measurement information system score after treatment. PROMIS-25 and PROMIS-29 scores are measured on a standardized scale of T-scores with a score of 50 representing the population average and higher scores representing worse outcomes. Participants who will be age 18 or older at six months after treatment initiation will be administered the PROMIS-25 adult version and age <18 will be administered the PROMIS-29 pediatric version.
Measured: Baseline to 6 months
Change in serum ferritin after treatment
Group median of individual change in ferritin
Measured: Baseline to 6 months
Change in von Willebrand Factor (VWF) levels
Group median of individual change in von Willebrand Factor levels
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start24 Sep 2025
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy Menstrual BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, NIH National Heart, Lung, and Blood Institute
- Responsible party
- Principal investigator, Maureen Baldwin, Oregon Health and Science University
- Investigators
- Maureen Baldwin, MD MPH, Principal investigator, Oregon Health and Science UniversityAllison Wheeler, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916469
- Sponsor's protocol ID
- LNG-IUD BD Study
- Acronym
- HMB-BD
- Status last verified
- Dec 2025
- First submitted
- 14 Jun 2023
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
- ClinicalTrials.gov ID
- NCT05916469
- Acronym / sponsor ID
- HMB-BD / LNG-IUD BD Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- University of Washington, NIH National Heart, Lung, and Blood Institute
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Heavy menstrual bleeding (HMB) is common among adolescents and young adults with an inherited bleeding disorder (BD) and negatively impacts health-related quality of life and physical and mental health status. Effective treatment options are available that decrease bleeding and improve quality of life, but were not studied in those with BD, so investigators do not know if there is similar effectiveness in this condition. The impact of treatment on diagnostic testing for BD or on improvement of iron deficiency is also not known. Given these gaps in knowledge, the primary objective of the Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study is to conduct a multicenter prospective observational cohort study and registry, enrolling adolescents and young adults with heavy menstrual bleeding cared for at collaborating interdisciplinary menstrual clinic sites nationally who are choosing to start use of either of two commonly used progestin menstrual treatment options: levonorgestrel-releasing intrauterine system (LNG-IUD) or oral norethindrone acetate 5 mg daily (NETA) (N=300). In Aim 1, the study will compare outcomes related to (a) bleeding management, (b) quality of life, and (c) repletion of iron storage levels after six months of treatment with either option in those with a diagnosed inherited bleeding disorder. The primary outcome will be treatment success with a Pictorial Blood Loss Assessment Chart (PBAC) score <50 points by six months. Secondary objectives to assess bleeding management will include need for adjuvant management, change in PBAC from baseline to 6 months, and self-reported treatment success. Quality of life outcomes will include change in validated scales to assess health-related quality of life which are specific to adolescents and young adults in the setting of heavy menstrual bleeding. The study will compare ferritin levels at six months compared to baseline to determine the relative amount of benefit obtained from either treatment option. In Aim 2, the study will compare outcomes after LNG-IUD in those with and without a bleeding disorder, assessing rates of expulsion and method continuation between the two groups in addition to the outcomes assessed for Aim 1. Aim 3 will improve our understanding of the impact of physiological stress on BD diagnostic studies by comparing change in hemostatic parameters before and after successful treatment in those with HMB without a previously diagnosed bleeding disorder. This study will demonstrate the relative benefits of menstrual suppression treatment options for adolescents and young adults with heavy menstrual bleeding and inherited bleeding disorders, will provide population-specific estimates for expected benefit that can be used in treatment counseling, and will highlight the impact of treatment status on diagnostic test results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bleeding disorder using LNG-IUD | – | Drug: Levonorgestrel Intrauterine SystemAdolescents and young adults ages 10-24 with diagnosed bleeding disorder planning use of LNG-IUD. |
| Non-bleeding disorder using LNG-IUD | – | Drug: Levonorgestrel Intrauterine SystemAdolescents and young adults ages 10-24 without diagnosed bleeding disorder planning use of LNG-IUD. |
| Bleeding disorder using NETA | – | Drug: Norethindrone AcetateAdolescents and young adults ages 10-24 with diagnosed bleeding disorder planning use of NETA. |
Who may qualify
- Ages
- 10 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant or seeking pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levonorgestrel Intrauterine SystemAlso: Mirena, Liletta52 mg levonorgestrel intrauterine system | Drug | Bleeding disorder using LNG-IUD, Non-bleeding disorder using LNG-IUD |
| Norethindrone AcetateAlso: Aygestinnorethindrone acetate 5 mg daily | Drug | Bleeding disorder using NETA |
Primary outcome
Treatment success rate
Time frame: 6 months
Proportion with pictorial blood loss assessment score <50 points
6 secondary outcomes
Median Pictorial Blood Assessment Chart (PBAC) score
Time frame: 6 months
Patient-reported treatment success rate
Time frame: 6 months
Change in Adolescent Menstrual Bleeding Questionnaire (aMBQ) score
Time frame: Baseline to 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-25 or PROMIS-29) scores
Time frame: Baseline to 6 months
Change in serum ferritin after treatment
Time frame: Baseline to 6 months
Change in von Willebrand Factor (VWF) levels
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maureen Baldwin, MD MPH principal investigator
Oregon Health and Science University
Allison Wheeler principal investigator
University of Washington
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heavy Menstrual Bleeding and Bleeding Disorder, run by Oregon Health and Science University at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact OHSU Women's Health Research Unit (5034943666, whru@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.