NCT05916469 Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
| NCT ID | NCT05916469 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oregon Health and Science University |
| Condition | Heavy Menstrual Bleeding |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-09-24 |
| Primary Completion | 2028-12 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
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