Actively Recruiting

Age: 10Years - 24Years
FEMALE
NCT05916469

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

Age: 10Years - 24Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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