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Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study

Recruitingn/aAges 10 Years - 24 YearsFemaleOregon Health and Science University
NCT05916469 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Levonorgestrel Intrauterine System
  • Norethindrone Acetate
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Where

9 sites
Stanford
Palo Alto, United States
Colorado Anschutz Medical Campus
Aurora, United States
Emory
Atlanta, United States
University of Michigan Medicine
Ann Arbor, United States
Children's Mercy
Kansas City, United States
Oregon Health & Science University
Portland, United States
Penn State Health
Hershey, United States
University of Washington
Seattle, United States

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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