Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 10
Maximum Age: 24
Healthy Volunteers: f
View:

• Post-menarcheal

• Ages 10-24

• Decision to initiate a trial of progestin therapy with either LNG-IUD or NETA

• Able to provide assent and written informed consent by one parent (ages \<18) or written informed consent (age 18+)

• Must meet trial criteria for heavy menstrual bleeding

• Must meet trial criteria for a bleeding disorder or have minimum workup to rule out bleeding disorder

Locations
United States
California
Stanford
NOT_YET_RECRUITING
Palo Alto
Colorado
Colorado Anschutz Medical Campus
NOT_YET_RECRUITING
Aurora
Georgia
Emory
NOT_YET_RECRUITING
Atlanta
Michigan
University of Michigan Medicine
NOT_YET_RECRUITING
Ann Arbor
Missouri
Children's Mercy
NOT_YET_RECRUITING
Kansas City
Oregon
Oregon Health & Science University
RECRUITING
Portland
Pennsylvania
Penn State Health
NOT_YET_RECRUITING
Hershey
Washington
Seattle Children's Hospital
NOT_YET_RECRUITING
Seattle
University of Washington
NOT_YET_RECRUITING
Seattle
Contact Information
Primary
OHSU Women's Health Research Unit
whru@ohsu.edu
5034943666
Backup
Maureen Baldwin, MD MPH
schaum@ohsu.edu
5034949762
Time Frame
Start Date: 2025-09-24
Estimated Completion Date: 2029-06
Participants
Target number of participants: 300
Treatments
Bleeding disorder using LNG-IUD
Adolescents and young adults ages 10-24 with diagnosed bleeding disorder planning use of LNG-IUD.
Non-bleeding disorder using LNG-IUD
Adolescents and young adults ages 10-24 without diagnosed bleeding disorder planning use of LNG-IUD.
Bleeding disorder using NETA
Adolescents and young adults ages 10-24 with diagnosed bleeding disorder planning use of NETA.
Sponsors
Collaborators: University of Washington, NIH National Heart, Lung, and Blood Institute
Leads: Oregon Health and Science University

This content was sourced from clinicaltrials.gov