Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study

Part of paid clinical trials in Palo Alto, California.

Sponsor
Oregon Health and Science University
Study ID
NCT05916469
Status
Recruiting
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Conditions

  • Bleeding Disorder
  • Heavy Menstrual Bleeding
  • Von Willebrand Diseases

Eligibility Criteria

Sex
FEMALE
Age
10 Years - 24 Years
Healthy Volunteers
Not accepted

Interventions

  • Levonorgestrel Intrauterine System — DRUG
    52 mg levonorgestrel intrauterine system
  • Norethindrone Acetate — DRUG
    norethindrone acetate 5 mg daily

Study Details

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 Dates

Start date
Sep 24, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Bleeding disorder using LNG-IUD
    Adolescents and young adults ages 10-24 with diagnosed bleeding disorder planning use of LNG-IUD.
  • Arm: Non-bleeding disorder using LNG-IUD
    Adolescents and young adults ages 10-24 without diagnosed bleeding disorder planning use of LNG-IUD.
  • Arm: Bleeding disorder using NETA
    Adolescents and young adults ages 10-24 with diagnosed bleeding disorder planning use of NETA.

Primary Outcome Measure

Treatment success rate [ Time Frame: 6 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
StanfordPalo AltoCalifornia94304-
Colorado Anschutz Medical CampusAuroraColorado80045-
EmoryAtlantaGeorgia30322-
University of Michigan MedicineAnn ArborMichigan48109-
Children's MercyKansas CityMissouri64108-
Oregon Health & Science UniversityPortlandOregon97239
Women's Health Research Unit
[email protected]
503-494-3666
Penn State HealthHersheyPennsylvania17003-
Seattle Children's HospitalSeattleWashington98105-
University of WashingtonSeattleWashington98101
Washington Center for Bleeding Disorders
[email protected]
206-614-1200

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By research site
Stanford· Palo Alto, CAColorado Anschutz Medical Campus· Aurora, COEmory· Atlanta, GAUniversity of Michigan Medicine· Ann Arbor, MIChildren's Mercy· Kansas City, MOOregon Health & Science University· Portland, OR

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