Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age10-24
SponsorOregon Health and Science University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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+)
Disqualifiers
Pregnant or seeking pregnancy
Trial population
Adolescents and young adults ages 10-24 with and without a heritable bleeding disorder who receive medical care for heavy menstrual bleeding at a participating U.S. clinical site. All clinical sites participate in a national consortium of interdisciplinary hematology-gynecology clinics.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Levonorgestrel Intrauterine System
Drug52 mg levonorgestrel intrauterine system
Norethindrone Acetate
Drugnorethindrone acetate 5 mg daily
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: Bleeding disorder using LNG-IUD1 intervention
Group B: Non-bleeding disorder using LNG-IUD1 intervention
Group C: Bleeding disorder using NETA1 intervention
Trial outcomes
Primary outcomes
1
Treatment success rate
Proportion with pictorial blood loss assessment score \<50 points
Time frame
6 monthsSecondary outcomes
1
Median Pictorial Blood Assessment Chart (PBAC) score
Group median of pictorial blood loss assessment score. PBAC scores start at 0 to represent no bleeding with higher PBAC scores representing heavy menstrual bleeding. There is no maximum PBAC score.
Time frame
6 months2
Patient-reported treatment success rate
Proportion with patient-reported treatment success. Treatment success will be measured with Yes or No bivariate response.
Time frame
6 months3
Change in Adolescent Menstrual Bleeding Questionnaire (aMBQ) score
Group median of individual change in adolescent menstrual bleeding questionnaire score. aMBQ scores can range from 0 to 77 with higher scores representing worse health-related quality of life.
Time frame
Baseline to 6 months4
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-25 or PROMIS-29) scores
Group median of individual change in patient-reported outcomes measurement information system score after treatment. PROMIS-25 and PROMIS-29 scores are measured on a standardized scale of T-scores with a score of 50 representing the population average and higher scores representing worse outcomes. Participants who will be age 18 or older at six months after treatment initiation will be administered the PROMIS-25 adult version and age \<18 will be administered the PROMIS-29 pediatric version.
Time frame
Baseline to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oregon Health and Science University
Lead sponsor
University of Washington
Collaborator
NIH National Heart, Lung, and Blood Institute
Collaborator
Source ClinicalTrials.gov