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RECRUITING
NCT05916469

Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study

Sponsor: Oregon Health and Science University

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

10 Years - 24 Years

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2025-09-24

Completion Date

2029-06

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

DRUG

Levonorgestrel Intrauterine System

52 mg levonorgestrel intrauterine system

DRUG

Norethindrone Acetate

norethindrone acetate 5 mg daily

Locations (9)

Stanford

Palo Alto, California, United States

Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Emory

Atlanta, Georgia, United States

University of Michigan Medicine

Ann Arbor, Michigan, United States

Children's Mercy

Kansas City, Missouri, United States

Oregon Health & Science University

Portland, Oregon, United States

Penn State Health

Hershey, Pennsylvania, United States

University of Washington

Seattle, Washington, United States

Seattle Children's Hospital

Seattle, Washington, United States