Recruiting

LNG-IUD vs. NETA

Sponsor:

Oregon Health and Science University

Code:

NCT05916469

Conditions

Heavy Menstrual Bleeding

Bleeding Disorder

Von Willebrand Diseases

Eligibility Criteria

Sex: Female

Age: 10 - 24

Healthy Volunteers: Not accepted

Interventions

Levonorgestrel Intrauterine System

Norethindrone Acetate

Study Details

Brief 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.

Conditions

Heavy Menstrual Bleeding

Bleeding Disorder

Von Willebrand Diseases

Study ID

NCT05916469

Start date

Sep 24, 2025

Status verified date

Dec, 2025

Completion date

Jun, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 10 - 24

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnant or seeking pregnancy

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Levonorgestrel Intrauterine System

52 mg levonorgestrel intrauterine system

Norethindrone Acetate

norethindrone acetate 5 mg daily

Primary outcome measure

  • Treatment success rate [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

OHSU Women's Health Research Unit

5034943666whru@ohsu.edu

Maureen Baldwin, MD MPH

5034949762schaum@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Women's Health Research Unit

503-494-3666whru@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-12-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.