Hypermobile Ehlers-Danlos SyndromeNCT05685199
Identifying the Determinants of Bleeding and Hypermobility in Patients With Heavy Menstrual Bleeding
An observational study of Hypermobile Ehlers-Danlos Syndrome and Heavy Menstrual Bleeding, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 40 years, women only
- Conditions the study is for
- Hypermobile Ehlers-Danlos Syndrome, Heavy Menstrual Bleeding, Hypermobility Syndrome (Disorder)
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2024to 6 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- Women only
- Child, Adult
Study population: Participants who meet the Eligibility criteria and consent
Who may be able to join
- Female
- Age 12-40 years
- Presence of HMB
- Evidence of severe iron-deficiency anemia (hemoglobin level of < 8 g/dL)
Who cannot join
- 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
Show all 21Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read the detailed description
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).
Please note: At the present time patient enrollment is limited to St. Jude established patients only.
- Conditions
- Hypermobile Ehlers-Danlos Syndrome, Heavy Menstrual Bleeding, Hypermobility Syndrome (Disorder)
- Keywords
- Heavy Menstrual Bleeding, Joint Hypermobility, Hypermobile Ehlers-Danlos Syndrome, Generalized joint Hypermobility Syndrome Disorder, Loose Joints
- Medical subject headings
- Ehlers-Danlos syndrome type 3, Menorrhagia, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case Group | Participants with heavy menstrual bleeding (HMB) | |
| Control Group | Participants without heavy menstrual bleeding (HMB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of bleeding symptoms in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): Self-Bleeding Assessment Tool (Self-Bat)
Summary statistics of bleed score including mean, median, standard deviation and range will be reported for women with and without G-HSD/hEDS. The Self-BAT which consist of 14 categories for assessing bleeding symptom will be used. Each of the 14 variables is scored from 0-4 (except CNS bleeding when the scores are 0, 3 and 4) and on the basis of this a final score is derived. Scores of ≥ 3 in children, ≥ 4 in adult males and ≥ 6 in adult females is considered abnormal.
Measured: Yearly for 3 years
Number of patients with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS).
The number of patients with G-HSD/hEDS will be reported
Measured: Approximately 3 years
Proportion of patients with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS).
The proportion of patients with G-HSD/hEDS will be reported
Measured: Approximately 3 years
Secondary outcomes (5)
Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS) - PHQ15
Investigators will compare co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS) using PHQ 15. The PHQ-15 is a subscale of the full Patient Health Questionnaire (PHQ) and screens for 15 somatic symptoms. It scores symptom presence and severity on a 3-point Likert scale (0-2). The total score ranges from 0-30 with higher values indicating increased severity as follows: Minimal (0-4); Low (5-9); Medium (10-14); High (15-30).
Measured: Yearly for 3 years
Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): Peds Patient-reported Outcomes Measurement Information System (PROMIS) 49 and Parent Proxy 49
Investigators will compare co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS) using Peds PROMIS 49 and Parent Proxy 49. The Peds PROMIS 49 is self-reported measures of global, physical, mental, and social health for children (ages 8-17) in the general population and those living with a chronic condition. The Parent Proxy 49 is intended for parents serving as proxy for their child (youth ages 5-17). PROMIS scores are reported as T scores ranging from 0-100. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like Anxiety, a T-score of 60 is one SD worse than average. By comparison, an Anxiety T-score of 40 is one SD better than average. However, for positively-worded concepts like Physical Function-Mobility, a T-score of 60 is one SD better than average while a T-score of 40 is one SD worse than average.
Measured: Yearly for 3 years
Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): PROMIS 57
Investigators will compare co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS) using adult PROMIS 57. The PROMIS 57 is for self-reporting measures of global, physical, mental, and social health for adults in the general population and those living with a chronic condition. PROMIS scores are reported as T scores ranging from 0-100. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like Anxiety, a T-score of 60 is one SD worse than average. By comparison, an Anxiety T-score of 40 is one SD better than average. However, for positively-worded concepts like Physical Function-Mobility, a T-score of 60 is one SD better than average while a T-score of 40 is one SD worse than average.
Measured: Yearly for 3 years
Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): Compass 31
Investigators will compare co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS) using COMPASS31. The COMPASS31 contains 31 questions with Likert scales ranging in length from 2 to 6 items with higher scores indicating increased severity. COMPASS31 provides raw scores and standardized scores providing a total weighted score (0-100) of severity. The scale yields 6 subscales and a total score as follows: Orthostatic intolerance (4-10), Vasomotor (3-6); Secretomotor (4-7); Gastrointestinal (12-28); Bladder (3-9); Pupillomotor (5-15); Total (31-75)
Measured: Yearly for 3 years
Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): Menstrual Distress Questionnaire
Investigators will compare co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS)using the Menstrual Distress Questionnaire. This is a 21-element survey (ENDOPAIN 4D) which measures the gynecological and pelvic pain symptoms associated with periods. Each question is on a 11-point Likert scale with higher scores reflecting more severe symptoms or symptoms that most closely resemble the description.
Measured: Yearly for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start10 May 2024
- Primary completion6 Jan 2026
- Study completion6 Jan 2026
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypermobile Ehlers-Danlos SyndromeStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wallace H. Coulter Foundation
- Responsible party
- Sponsor
- Investigators
- Rohith Jesudas, MBBS, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685199
- Sponsor's protocol ID
- IDBLEED
- Status last verified
- Jan 2026
- First submitted
- 15 Dec 2022
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying the Determinants of Bleeding and Hypermobility in Patients With Heavy Menstrual Bleeding
- ClinicalTrials.gov ID
- NCT05685199
- Acronym / sponsor ID
- IDBLEED
- Conditions
- Hypermobile Ehlers-Danlos Syndrome, Heavy Menstrual Bleeding, Hypermobility Syndrome (Disorder)
- Keywords
- Heavy Menstrual Bleeding, Joint Hypermobility, Hypermobile Ehlers-Danlos Syndrome, Generalized joint Hypermobility Syndrome Disorder, Loose Joints
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 15 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- Wallace H. Coulter Foundation
- Study start
- 10 May 2024 (actual)
- Primary completion
- 6 Jan 2026 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Please note: At the present time patient enrollment is limited to St. Jude established patients only.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | –Participants with heavy menstrual bleeding (HMB) |
| Control Group | – | –Participants without heavy menstrual bleeding (HMB) |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Participants who meet the Eligibility criteria and consent
Key inclusion criteria (4 listed)
- Female
- Age 12-40 years
- Presence of HMB
- Evidence of severe iron-deficiency anemia (hemoglobin level of < 8 g/dL)
Key exclusion criteria (21 listed)
- 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:
- Presence of a bleeding disorder indicated by prothrombin time, activated partial thromboplastin time, fibrinogen, and von Willebrand factor activity, antigen and factor VIII
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Severity of bleeding symptoms in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): Self-Bleeding Assessment Tool (Self-Bat)
Time frame: Yearly for 3 years
Summary statistics of bleed score including mean, median, standard deviation and range will be reported for women with and without G-HSD/hEDS. The Self-BAT which consist of 14 categories for assessing bleeding symptom will be used. Each of the 14 variables is scored from 0-4 (except CNS bleeding when the scores are 0, 3 and 4) and on the basis of this a final score is derived. Scores of ≥ 3 in children, ≥ 4 in adult males and ≥ 6 in adult females is considered abnormal.
Number of patients with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS).
Time frame: Approximately 3 years
The number of patients with G-HSD/hEDS will be reported
Proportion of patients with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS).
Time frame: Approximately 3 years
The proportion of patients with G-HSD/hEDS will be reported
5 secondary outcomes
Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS) - PHQ15
Time frame: Yearly for 3 years
Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): Peds Patient-reported Outcomes Measurement Information System (PROMIS) 49 and Parent Proxy 49
Time frame: Yearly for 3 years
Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): PROMIS 57
Time frame: Yearly for 3 years
Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): Compass 31
Time frame: Yearly for 3 years
Co-morbidities in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): Menstrual Distress Questionnaire
Time frame: Yearly for 3 years
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- ClinicalTrials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rohith Jesudas, MBBS principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypermobile Ehlers-Danlos Syndrome and Heavy Menstrual Bleeding, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of bleeding symptoms in women with and without Generalized joint Hypermobility Syndrome Disorder/ hypermobile Ehlers-Danlos Syndrome (G-HSD/hEDS): Self-Bleeding Assessment Tool (Self-Bat) (time frame: Yearly for 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.