Identifying the Determinants of Bleeding and Hypermobility in Patients With Heavy Menstrual Bleeding

Stopped early

Conditions studied: Hypermobile Ehlers-Danlos Syndrome, Heavy Menstrual Bleeding, Hypermobility Syndrome (Disorder)

In brief

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.

Key facts

Study ID

NCT05685199

Run by

St. Jude Children's Research Hospital

People needed

15

Starts

2024-05-10

Expected to finish

2026-01-06

Last updated by the study team

2026-01-28

Who can join

Age: 12 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female
• Age 12-40 years
• Presence of HMB
• Evidence of severe iron-deficiency anemia (hemoglobin level of < 8 g/dL)

You may not qualify if…

• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
• Current use of anticoagulant and antiplatelet medications
• Currently pregnant
• Medical conditions that could cause HMB but are not necessarily a bleeding disorder, including, but not limited to:
• Uncontrolled hypertension
• Documented uterine structural abnormality
• Insulin-dependent diabetes mellitus
• Chronic kidney disease
• Chronic liver disease
• Thyroid disease
• Documented peripheral arterial disease, venous or arterial vascular events in the past
• A structural pathology that would explain the HMB
• Presence of a bleeding disorder indicated by prothrombin time, activated partial thromboplastin time, fibrinogen, and von Willebrand factor activity, antigen and factor VIII
• Persistent thrombocytopenia as defined by a platelet count of <150,000/uL
• If the participant answers "yes" to any of the following questions, they are ineligible:
• Could the patient have a known connective tissue disorder?
• Family history of sudden death
• Family history/personal history of uterine rupture or bowel perforation
• Family history/personal history of arterial rupture
• Family history/personal history of aneurysm
• Family history/personal history of an established EDS diagnosis based on genetic evaluation

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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