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Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
NCT05916469 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Levonorgestrel Intrauterine System
- DRUG Norethindrone Acetate
Study Locations (9)
Washington
- University of Washington — Seattle
- Seattle Children's Hospital — Seattle
California
- Stanford — Palo Alto
Colorado
- Colorado Anschutz Medical Campus — Aurora
Georgia
- Emory — Atlanta
Michigan
- University of Michigan Medicine — Ann Arbor
Missouri
- Children's Mercy — Kansas City
Oregon
- Oregon Health & Science University — Portland
Pennsylvania
- Penn State Health — Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2025-09-24 |
| Est. Completion | 2029-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05916469
The ClinicalTrials.gov registry entry for NCT05916469 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 665 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Heavy Menstrual Bleeding appearing as the primary indexed condition, and to 2 interventions — of which Levonorgestrel Intrauterine System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05916469 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Washington, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05916469 about?
NCT05916469 is a clinical study titled "Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study". 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 ...
What is the current status of trial NCT05916469?
This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2025-09-24. Estimated completion is 2029-06.
What conditions does trial NCT05916469 study?
This clinical trial studies the following conditions: Heavy Menstrual Bleeding, Von Willebrand Diseases, Bleeding Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05916469?
The interventions under investigation include: Levonorgestrel Intrauterine System (DRUG), Norethindrone Acetate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05916469?
This trial is sponsored by Oregon Health and Science University, which has 665 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05916469 being conducted?
This trial has 9 study locations across California, Colorado, Georgia, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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