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Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study

NCT05916469 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-12-17

No results posted yet for this study

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.

Conditions

  • Heavy Menstrual Bleeding
  • Bleeding Disorder
  • Von Willebrand Diseases

Interventions

DRUG

Norethindrone Acetate

norethindrone acetate 5 mg daily

DRUG

Levonorgestrel Intrauterine System

52 mg levonorgestrel intrauterine system

Sponsors & Collaborators

  • University of Washington

    collaborator OTHER

  • NIH National Heart, Lung, and Blood Institute

    collaborator UNKNOWN

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Maureen Baldwin, MD MPH · Oregon Health and Science University

  • Allison Wheeler · University of Washington

Eligibility

Min Age
10 Years
Max Age
24 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-24
Primary Completion
2028-12-31
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05916469 on ClinicalTrials.gov