Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2026-01-01 @ 2:00 PM
Study NCT ID:
NCT05916469
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2023-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008595', 'term': 'Menorrhagia'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014842', 'term': 'von Willebrand Diseases'}], 'ancestors': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016912', 'term': 'Levonorgestrel'}, {'id': 'D000077563', 'term': 'Norethindrone Acetate'}], 'ancestors': [{'id': 'D009644', 'term': 'Norgestrel'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D009640', 'term': 'Norethindrone'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2023-06-14', 'studyFirstSubmitQcDate': '2023-06-14', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment success rate', 'timeFrame': '6 months', 'description': 'Proportion with pictorial blood loss assessment score \\<50 points'}], 'secondaryOutcomes': [{'measure': 'Median Pictorial Blood Assessment Chart (PBAC) score', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Patient-reported treatment success rate', 'timeFrame': '6 months', 'description': 'Proportion with patient-reported treatment success. Treatment success will be measured with Yes or No bivariate response.'}, {'measure': 'Change in Adolescent Menstrual Bleeding Questionnaire (aMBQ) score', 'timeFrame': 'Baseline to 6 months', 'description': '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.'}, {'measure': 'Change in Patient-Reported Outcomes Measurement Information System (PROMIS-25 or PROMIS-29) scores', 'timeFrame': 'Baseline to 6 months', 'description': '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.'}, {'measure': 'Change in serum ferritin after treatment', 'timeFrame': 'Baseline to 6 months', 'description': 'Group median of individual change in ferritin'}, {'measure': 'Change in von Willebrand Factor (VWF) levels', 'timeFrame': 'Baseline to 6 months', 'description': 'Group median of individual change in von Willebrand Factor levels'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heavy Menstrual Bleeding', 'Bleeding Disorder', 'Von Willebrand Diseases']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post-menarcheal\n* Ages 10-24\n* Decision to initiate a trial of progestin therapy with either LNG-IUD or NETA\n* Able to provide assent and written informed consent by one parent (ages \\<18) or written informed consent (age 18+)\n* Must meet trial criteria for heavy menstrual bleeding\n* Must meet trial criteria for a bleeding disorder or have minimum workup to rule out bleeding disorder\n\nExclusion Criteria:\n\n* Pregnant or seeking pregnancy'}, 'identificationModule': {'nctId': 'NCT05916469', 'acronym': 'HMB-BD', 'briefTitle': 'Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study', 'orgStudyIdInfo': {'id': 'LNG-IUD BD Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bleeding disorder using LNG-IUD', 'description': 'Adolescents and young adults ages 10-24 with diagnosed bleeding disorder planning use of LNG-IUD.', 'interventionNames': ['Drug: Levonorgestrel Intrauterine System']}, {'label': 'Non-bleeding disorder using LNG-IUD', 'description': 'Adolescents and young adults ages 10-24 without diagnosed bleeding disorder planning use of LNG-IUD.', 'interventionNames': ['Drug: Levonorgestrel Intrauterine System']}, {'label': 'Bleeding disorder using NETA', 'description': 'Adolescents and young adults ages 10-24 with diagnosed bleeding disorder planning use of NETA.', 'interventionNames': ['Drug: Norethindrone Acetate']}], 'interventions': [{'name': 'Levonorgestrel Intrauterine System', 'type': 'DRUG', 'otherNames': ['Mirena', 'Liletta'], 'description': '52 mg levonorgestrel intrauterine system', 'armGroupLabels': ['Bleeding disorder using LNG-IUD', 'Non-bleeding disorder using LNG-IUD']}, {'name': 'Norethindrone Acetate', 'type': 'DRUG', 'otherNames': ['Aygestin'], 'description': 'norethindrone acetate 5 mg daily', 'armGroupLabels': ['Bleeding disorder using NETA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Stanford', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Emory', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'University of Michigan Medicine', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': "Children's Mercy", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': "Women's Health Research Unit", 'role': 'CONTACT', 'email': 'whru@ohsu.edu', 'phone': '503-494-3666'}], 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17003', 'city': 'Hershey', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Penn State Health', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Washington Center for Bleeding Disorders', 'role': 'CONTACT', 'email': 'WICResearch@WACBD.org', 'phone': '206-614-1200'}], 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': "OHSU Women's Health Research Unit", 'role': 'CONTACT', 'email': 'whru@ohsu.edu', 'phone': '5034943666'}, {'name': 'Maureen Baldwin, MD MPH', 'role': 'CONTACT', 'email': 'schaum@ohsu.edu', 'phone': '5034949762'}], 'overallOfficials': [{'name': 'Maureen Baldwin, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}, {'name': 'Allison Wheeler', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': '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.', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': "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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'NIH National Heart, Lung, and Blood Institute', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Ob/Gyn', 'investigatorFullName': 'Maureen Baldwin', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}