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
26 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
This research aims to better understand heavy menstrual bleeding (HMB) in adolescents and young adults who have inherited bleeding disorders. It focuses on how two commonly used hormonal treatments for menstrual suppression—levonorgestrel-releasing intrauterine device (LNG-IUD) and oral norethindrone acetate (NETA)—affect bleeding outcomes, patient satisfaction, changes in blood clotting parameters, and quality of life over six months. The study also compares results from those using LNG-IUD with individuals without bleeding disorders to better understand treatment benefits and expected outcomes in this population. Participants will choose to start either the LNG-IUD, a device that releases levonorgestrel hormone, or daily oral norethindrone acetate at 5 mg. The study includes three groups: those with bleeding disorders using LNG-IUD, those without bleeding disorders using LNG-IUD, and those with bleeding disorders using NETA. The study observes the treatments prospectively without assigning them randomly, focusing on real-world use. Researchers will track treatment success, bleeding management, quality of life, iron levels, and blood clotting changes over six months. During the study, participants will complete assessments including bleeding diaries using the Pictorial Blood Loss Assessment Chart, quality of life questionnaires specific to adolescents and young adults, and blood tests to measure iron and clotting factors before and after treatment. The study will also monitor device continuation and expulsion rates for LNG-IUD users. The total participation period involves six months of observation and data collection to evaluate treatment outcomes and effects on diagnostic testing for bleeding disorders.
CONDITIONS
Brief 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 start treatment with either LNG-IUD or norethindrone acetate (NETA)
- Able to provide assent and written consent (parental consent if under 18)
- Diagnosed with heavy menstrual bleeding
- Diagnosed with a bleeding disorder or evaluated 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants begin treatment with either the levonorgestrel-releasing intrauterine system (LNG-IUD) or oral norethindrone acetate 5 mg daily (NETA) to manage heavy menstrual bleeding and improve quality of life.
Visits occur at baseline and periodically during treatment to monitor progress and collect outcomes
Duration - Up to 6 months after treatment
Participants are monitored for treatment success, changes in bleeding, quality of life, iron levels, and diagnostic parameters after completing 6 months of treatment.
Additional follow-up visits may occur depending on individual treatment response
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
M
Maureen Baldwin, MD MPH
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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