Actively Recruiting
Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
Led by Oregon Health and Science University · Updated on 2025-12-17
300
Participants Needed
9
Research Sites
192 weeks
Total Duration
On this page
Sponsors
O
Oregon Health and Science University
Lead Sponsor
U
University of Washington
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Post-menarcheal
- Ages 10 to 24 years
- Decision to begin progestin therapy with either levonorgestrel intrauterine system or norethindrone acetate
- Able to provide assent and written informed consent by parent if under 18, or written informed consent if 18 or older
- Meets trial criteria for heavy menstrual bleeding
- Meets trial criteria for a bleeding disorder or has had minimum testing to rule out bleeding disorder
You will not qualify if you...
- Pregnant or seeking pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Stanford
Palo Alto, California, United States, 94304
Not Yet Recruiting
2
Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Not Yet Recruiting
3
Emory
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
4
University of Michigan Medicine
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
5
Children's Mercy
Kansas City, Missouri, United States, 64108
Not Yet Recruiting
6
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
7
Penn State Health
Hershey, Pennsylvania, United States, 17003
Not Yet Recruiting
8
University of Washington
Seattle, Washington, United States, 98101
Not Yet Recruiting
9
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Not Yet Recruiting
Research Team
O
OHSU Women's Health Research Unit
CONTACT
M
Maureen Baldwin, MD MPH
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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