Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study

Heavy Menstrual Bleeding Clinical Trial

— HMB-BD  

Official title:

Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05916469
• Other study ID #: LNG-IUD BD Study
• Status: Not yet recruiting
• Start date: July 2024
• Est. completion date: June 2029

Study information

• Verified date: June 2023
• Source: Oregon Health and Science University
• Contact: OHSU Women's Health Research Unit
• Phone: 5034943666
• Email: whru[@]ohsu.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 hormonal treatments for menstrual suppression - levonorgestrel intrauterine device (LNG-IUD) and norethindrone acetate (NETA). Under this application we 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.

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 we do not know if there is similar effectiveness in this condition. We also do not know the impact of treatment on diagnostic testing for BD or on improvement of iron deficiency. 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, we 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. We 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, we 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. In Aim 3, we 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: June 2029
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years to 24 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnant or seeking pregnancy

Related Conditions & MeSH terms

• Bleeding Disorder
• Blood Coagulation Disorders
• Heavy Menstrual Bleeding
• Hemorrhage
• Hemorrhagic Disorders
• Hemostatic Disorders
• Menorrhagia
• Von Willebrand Diseases

Intervention

Drug:
• Levonorgestrel Intrauterine System
52 mg levonorgestrel intrauterine system
• Norethindrone Acetate
norethindrone acetate 5 mg daily

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Vanderbilt University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment success rate	Proportion with pictorial blood loss assessment score <50 points	6 months
Secondary	Median PBAC	Group median of pictorial blood loss assessment score	6 months
Secondary	Patient-reported treatment success rate	Proportion with patient-reported treatment success	6 months
Secondary	Change in aMBQ score	Group median of individual change in adolescent menstrual bleeding questionnaire score	Baseline to 6 months
Secondary	Change in PROMIS score	Group median of individual change in patient-reported outcomes measurement information system score	Baseline to 6 months
Secondary	Change in ferritin	Group median of individual change in ferritin	Baseline to 6 months
Secondary	Change in von Willebrand Factor (VWF) levels	Group median of individual change in von Willebrand Factor levels	Baseline to 6 months