Heavy Menstrual Bleeding Clinical Trial
Official title:
Identifying the Determinants of Bleeding and Hypermobility in Patients With Heavy Menstrual Bleeding
In this study, researchers want to learn about the connection between heavy bleeding issues and joint hypermobility (loose joints). They want to know if these issues may indicate other connective tissue problems in girls and women with heavy menstrual bleeding who do not have a known cause. Primary Objective - Compare the severity of heavy menstrual bleeding (HMB) in women with and without Generalized joint Hypermobility Syndrome Disorder/hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS) using bleeding scores. Secondary Objectives - Compare the frequency of co-morbidities in women with and without G-HSD/hEDS.
The researchers will screen for patients referred to St. Jude due to HMB. Patients will be eligible for inclusion and offered to be screened for enrollment in this study if the duration of their menses was greater than or equal to 7 days, and they reported either "flooding" or bleeding through a tampon or napkin in 2 hours or less with most periods, have no identifiable bleeding disorder, and have evidence of severe iron deficiency anemia (hemoglobin < 8 g/dL). Once enrolled, joint hypermobility will be evaluated using a Beighton score which will be used to assign participants to two groups: with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS). Participants will then undergo a detailed clinical examination to further classify them using the 2017 diagnostic criteria and complete symptom questionnaires. Finally, participants will be consented to TBANK (NCT01354002) and INSIGHT HD (NCT02720679) to provide a sample of leftover blood for banking for future research. Participants will be seen annually for the next 3 years as part of their standard of care to document the course of their symptoms. Visit 1: Self-BAT Questionnaire, Beighton Score examination, 2017 hEDS examination, PROMIS (Peds/Parent) questionnaire, PHQ15 questionnaire, COMPASS31 questionnaire, Menstrual distress questionnaire (ENDOPAIN), and Heavy menstrual bleeding checklist (both pediatric and adult). Visit 2: Self-BAT Questionnaire, PROMIS (Peds/Parent) questionnaire, PHQ15 questionnaire, COMPASS31 questionnaire, Menstrual distress questionnaire (ENDOPAIN). Visit 3: Self-BAT Questionnaire, PROMIS (Peds/Parent) questionnaire, PHQ15 questionnaire, COMPASS31 questionnaire, Menstrual distress questionnaire (ENDOPAIN). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02934789 -
Effectiveness of Truclear on Patient Quality of Life
|
N/A | |
Completed |
NCT02925494 -
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
|
Phase 3 | |
Recruiting |
NCT04959396 -
IUB SEAD RED (Revolutionary Endometrial Ablation Device Study
|
N/A | |
Active, not recruiting |
NCT04778072 -
A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects
|
N/A | |
Terminated |
NCT05026502 -
A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
|
||
Recruiting |
NCT06064851 -
Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Von Willebrand Disease Patients
|
N/A | |
Terminated |
NCT04132349 -
Ulipristal Acetate in Symptomatic Uterine Fibroid
|
Phase 4 | |
Completed |
NCT00386308 -
Efficacy and Safety Study of XP12B in Women With Menorrhagia
|
Phase 3 | |
Completed |
NCT03412890 -
LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
|
Phase 3 | |
Active, not recruiting |
NCT04477837 -
Prospective Comparison of Incidence of Heavy Menstrual Bleeding in Women Treated With Direct Oral Anticoagulants
|
||
Completed |
NCT05176496 -
A Study Called Champion-HMB to Learn More About Females With Heavy Menstrual Bleeding and Available Treatments to Enable Earlier Diagnosis and to Predict Courses of Treatment
|
||
Completed |
NCT01431326 -
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
|
||
Completed |
NCT00401193 -
Efficacy and Safety of XP12B in Women With Menorrhagia
|
Phase 3 | |
Completed |
NCT03317795 -
Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids
|
Phase 4 | |
Completed |
NCT02943655 -
Treatment of Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause
|
Phase 3 | |
Completed |
NCT03070951 -
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
|
Phase 3 | |
Completed |
NCT05406960 -
Therapeutic Effect of Herbal Infusion on Menometrorrhagia
|
N/A | |
Not yet recruiting |
NCT05079815 -
Heavy Menstrual Bleeding and Iron Deficiency Anemia
|
||
Active, not recruiting |
NCT02449304 -
Evaluation of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device
|
Phase 4 | |
Terminated |
NCT02001324 -
HMB- Data Collection Methods
|
N/A |