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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 12 Years - 40 Years
Gender Female
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

    Exclusion Criteria:

    - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05685199
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 St. Jude Children's Research Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Rohith Jesudas, MBBS
Principal Investigator Affiliation St. Jude Children's Research Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Hypermobile Ehlers-Danlos Syndrome, Heavy Menstrual Bleeding, Hypermobility Syndrome (Disorder)
Study Website: View Trial Website
Additional Details

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).

Arms & Interventions

Arms

: Case Group

Participants with heavy menstrual bleeding (HMB)

: Control Group

Participants without heavy menstrual bleeding (HMB)

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

St. Jude Children's Research Hospital, Memphis, Tennessee

Status

Recruiting

Address

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105

Site Contact

Rohith Jesudas, MBBS

[email protected]

866-278-5833

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