Ehlers-Danlos Syndrome (EDS)GYNESEDNCT07151274
Impact of Ehlers-Danlos Syndrome on Gynaecological Health
An observational study of Ehlers-Danlos Syndrome (EDS), run by University Hospital, Rouen at 1 site in France.
Trial summary
Dysmenorrhea is a common problem in gynaecology, significantly impacting patients' quality of life. Ehlers-Danlos syndrome (EDS) is associated with joint hypermobility, tissue fragility and chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ehlers-Danlos Syndrome (EDS)
- How many people
- 156 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2025to 1 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women diagnosed with Ehlers-Danlos syndrome (EDS)
Who may be able to join
- Women aged 18 or over.
- Willing to participate voluntarily in the study via an online questionnaire.
- Of childbearing age.
- Reporting a diagnosis of EDS (all types) or not having EDS (control group) and being part of a database of healthy volunteers.
Who cannot join
- Minors (< 18 years old).
- Menopausal women
- People who do not understand French well enough to complete the questionnaire.
- Uncertain diagnosis of EDS (exclusion of participants who suspect EDS but without medical confirmation).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de ROUEN
Rouen, 76031
Melodie Lecointre, 02 32 88 07 89, melodie.lecointre@chu-rouen.fr
Melodie Lecointre
About this study
Official title: Impact of Ehlers-Danlos Syndrome on Gynaecological Health: Focus on the Prevalence of Dysmenorrhoea
Dysmenorrhea is a common problem in gynaecology, significantly impacting patients' quality of life. Ehlers-Danlos syndrome (EDS) is associated with joint hypermobility, tissue fragility and chronic pain. Some studies suggest an increased prevalence of gynaecological disorders, including dysmenorrhea, in patients with EDS. However, data remain limited and few studies have compared the intensity and characteristics of dysmenorrhea in women with EDS. There is also little data on the prevalence of other gynaecological conditions in women with EDS.
This study therefore aims to compare the severity of dysmenorrhea in patients with EDS and a control group in order to better characterise the gynaecological impact of EDS. It will also compare the prevalence of other gynaecological conditions between women with EDS and women without EDS.
Read the detailed description
Patients with SED report a high prevalence of gynaecological disorders, including severe dysmenorrhoea, menorrhagia and dyspareunia. Chronic pelvic pain and pelvic floor disorders are also common, impacting quality of life and reproductive function. Menorrhagia is common and may be due to capillary fragility and altered uterine connective tissue. The use of contraceptive hormones is often considered to reduce menstrual symptoms, although their effectiveness varies. A multidisciplinary approach is recommended to tailor treatments to the specific needs of patients.
Epidemiological data on the prevalence of EDS and hypermobility spectrum disorder show an increase in diagnoses, highlighting the importance of better clinical recognition.
Primary dysmenorrhoea is generally linked to excessive production of prostaglandins, leading to uterine hypercontractility and transient myometrial ischaemia. In patients with EDS, several pathophysiological mechanisms could contribute to exacerbated menstrual pain:
- Collagen dysregulation: fragility of uterine connective tissues that can alter myometrial contractility.
- Frequent dysautonomia in SED: may alter uterine vascularisation and amplify pain.
- Nociceptive hypersensitivity: described in patients with SED, increasing pain perception. This project hypothesises that patients with EDS experience more severe and/or more frequent dysmenorrhoea than the general population due to the tissue and neurological alterations specific to this syndrome.
Thus, evidence of increased dysmenorrhoea severity in EDS patients could justify better pain management and gynaecological care for these patients.
Better recognition of gynaecological disorders in EDS could prevent late diagnoses and therapeutic uncertainty.
Better recognition of gynaecological disorders in EDS could help to avoid late diagnoses and therapeutic uncertainty.
The prospects for this research are to show that a significant difference could be observed and to explore the underlying mechanisms (dysautonomia, local inflammation, myometrial abnormalities) in greater depth. The benefits of specialised gynaecological care with the introduction of hormone therapy could also be explored.
- Conditions
- Ehlers-Danlos Syndrome (EDS)
- Keywords
- gynaecological disorder, dysmenorrhea, menorrhagia, dyspareunia, endometriosis
- Medical subject headings
- Ehlers-Danlos Syndrome, Dysmenorrhea, Menorrhagia, Dyspareunia, Endometriosis
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 |
|---|---|---|
| Experimental group: women with Ehlers-Danlos syndrome (EDS) | Women with Ehlers-Danlos syndrome (EDS) of all types diagnosed by a healthcare professional | |
| Comparator group: Women not affected by Ehlers-Danlos syndrome (EDS) | Women without Ehlers-Danlos syndrome (EDS) (control group) from a healthy volunteer base |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the severity of dysmenorrhea by Numerical Pain Scale (NPS)
The main objective of this study is to compare the severity of dysmenorrhea in patients with Ehlers-Danlos syndrome (EDS), all types combined, and a control group of patients without connective tissue disease. This comparison will determine whether EDS is a risk factor for more severe dysmenorrhea. The primary endpoint will be measured using the numerical pain scale (NPS), which assesses pain intensity on a scale of 0 to 10. A score of 10 corresponds to the "maximum imaginable pain"
Measured: Day 1
Secondary outcomes (10)
Analysis of clinical factors associated with the severity of dysmenorrhea (Age) using Numerical Pain Scale (NPS)
Examine the impact of age on the intensity of dysmenorrhea, measured by the numerical pain scale (NPS). The outcome measure will be the Numerical Pain Scale (NPS), which rates pain intensity on a scale of 0 to 10. A score of 10 corresponds to the "maximum imaginable pain."
Measured: Day1
Analysis of clinical factors associated with the severity of dysmenorrhea (Body Mass Index (BMI)) using Numerical Pain Scale (NPS)
Examine the impact of BMI on the intensity of dysmenorrhea, measured by the numerical pain scale (NPS). The outcome measure will be the Numerical Pain Scale (NPS), which rates pain intensity on a scale of 0 to 10. A score of 10 corresponds to the "maximum imaginable pain."
Measured: Day1
Analysis of clinical factors associated with the severity of dysmenorrhea (age of onset of dysmenorrhea,) using Numerical Pain Scale (NPS)
Examine the impact of age of onset of dysmenorrhea, on the intensity of dysmenorrhea, measured by the numerical pain scale (NPS). The outcome measure will be the Numerical Pain Scale (NPS), which rates pain intensity on a scale of 0 to 10. A score of 10 corresponds to the "maximum imaginable pain."
Measured: Day1
Analysis of clinical factors associated with the severity of dysmenorrhea (presence of associated menorrhagia) using Numerical Pain Scale (NPS)
Examine the impact of presence of associated menorrhagia on the intensity of dysmenorrhea, measured by the numerical pain scale (NPS). The outcome measure will be the Numerical Pain Scale (NPS), which rates pain intensity on a scale of 0 to 10. A score of 10 corresponds to the "maximum imaginable pain.".
Measured: Day1
Analysis of clinical factors associated with the severity of dysmenorrhea (medical history) using Numerical Pain Scale (NPS)
Examine the impact of medical history on the intensity of dysmenorrhea, measured by the numerical pain scale (NPS). The outcome measure will be the Numerical Pain Scale (NPS), which rates pain intensity on a scale of 0 to 10. A score of 10 corresponds to the "maximum imaginable pain."
Measured: Day1
Study of the prevalence of gynaecological conditions (menorrhagia)
Evaluate the frequency of occurrence of a menorrhagia
Measured: Day 1
Study of the prevalence of gynaecological conditions (endometriosis)
Evaluate the frequency of occurrence of endometriosis
Measured: Day 1
Study of the prevalence of gynaecological conditions (adenomyosis)
Evaluate the frequency of occurrence of a adenomyosis
Measured: Day 1
Study of the prevalence of gynaecological conditions (PolyCystic ovary syndrome (PCOS))
Evaluate the frequency of occurrence of PCOS
Measured: Day 1
Study of the prevalence of gynaecological conditions (abnormal cervical smear)
Evaluate the frequency of occurrence of abnormal cervical smear
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start7 Jul 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ehlers-Danlos Syndrome (EDS)Studies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151274
- Sponsor's protocol ID
- 2025/0124/OB
- Other IDs
- 2025-A00962-47
- Acronym
- GYNESED
- Status last verified
- Jun 2026
- First submitted
- 21 Aug 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ehlers-Danlos Syndrome on Gynaecological Health: Focus on the Prevalence of Dysmenorrhoea
- ClinicalTrials.gov ID
- NCT07151274
- Acronym / sponsor ID
- GYNESED / 2025/0124/OB
- Conditions
- Ehlers-Danlos Syndrome (EDS)
- Keywords
- gynaecological disorder, dysmenorrhea, menorrhagia, dyspareunia, endometriosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 3 Sep 2025 (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.
Dysmenorrhea is a common problem in gynaecology, significantly impacting patients' quality of life. Ehlers-Danlos syndrome (EDS) is associated with joint hypermobility, tissue fragility and chronic pain. Some studies suggest an increased prevalence of gynaecological disorders, including dysmenorrhea, in patients with EDS. However, data remain limited and few studies have compared the intensity and characteristics of dysmenorrhea in women with EDS. There is also little data on the prevalence of other gynaecological conditions in women with EDS.
This study therefore aims to compare the severity of dysmenorrhea in patients with EDS and a control group in order to better characterise the gynaecological impact of EDS. It will also compare the prevalence of other gynaecological conditions between women with EDS and women without EDS.
Detailed description
Patients with SED report a high prevalence of gynaecological disorders, including severe dysmenorrhoea, menorrhagia and dyspareunia. Chronic pelvic pain and pelvic floor disorders are also common, impacting quality of life and reproductive function. Menorrhagia is common and may be due to capillary fragility and altered uterine connective tissue. The use of contraceptive hormones is often considered to reduce menstrual symptoms, although their effectiveness varies. A multidisciplinary approach is recommended to tailor treatments to the specific needs of patients.
Epidemiological data on the prevalence of EDS and hypermobility spectrum disorder show an increase in diagnoses, highlighting the importance of better clinical recognition.
Primary dysmenorrhoea is generally linked to excessive production of prostaglandins, leading to uterine hypercontractility and transient myometrial ischaemia. In patients with EDS, several pathophysiological mechanisms could contribute to exacerbated menstrual pain:
- Collagen dysregulation: fragility of uterine connective tissues that can alter myometrial contractility.
- Frequent dysautonomia in SED: may alter uterine vascularisation and amplify pain.
- Nociceptive hypersensitivity: described in patients with SED, increasing pain perception. This project hypothesises that patients with EDS experience more severe and/or more frequent dysmenorrhoea than the general population due to the tissue and neurological alterations specific to this syndrome.
Thus, evidence of increased dysmenorrhoea severity in EDS patients could justify better pain management and gynaecological care for these patients.
Better recognition of gynaecological disorders in EDS could prevent late diagnoses and therapeutic uncertainty.
Better recognition of gynaecological disorders in EDS could help to avoid late diagnoses and therapeutic uncertainty.
The prospects for this research are to show that a significant difference could be observed and to explore the underlying mechanisms (dysautonomia, local inflammation, myometrial abnormalities) in greater depth. The benefits of specialised gynaecological care with the introduction of hormone therapy could also be explored.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: women with Ehlers-Danlos syndrome (EDS) | – | –Women with Ehlers-Danlos syndrome (EDS) of all types diagnosed by a healthcare professional |
| Comparator group: Women not affected by Ehlers-Danlos syndrome (EDS) | – | –Women without Ehlers-Danlos syndrome (EDS) (control group) from a healthy volunteer base |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women diagnosed with Ehlers-Danlos syndrome (EDS)
Key inclusion criteria (4 listed)
- Women aged 18 or over.
- Willing to participate voluntarily in the study via an online questionnaire.
- Of childbearing age.
- Reporting a diagnosis of EDS (all types) or not having EDS (control group) and being part of a database of healthy volunteers.
Key exclusion criteria (4 listed)
- Minors (< 18 years old).
- Menopausal women
- People who do not understand French well enough to complete the questionnaire.
- Uncertain diagnosis of EDS (exclusion of participants who suspect EDS but without medical confirmation).
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
Assessment of the severity of dysmenorrhea by Numerical Pain Scale (NPS)
Time frame: Day 1
The main objective of this study is to compare the severity of dysmenorrhea in patients with Ehlers-Danlos syndrome (EDS), all types combined, and a control group of patients without connective tissue disease. This comparison will determine whether EDS is a risk factor for more severe dysmenorrhea. The primary endpoint will be measured using the numerical pain scale (NPS), which assesses pain intensity on a scale of 0 to 10. A score of 10 corresponds to the "maximum imaginable pain"
10 secondary outcomes
Analysis of clinical factors associated with the severity of dysmenorrhea (Age) using Numerical Pain Scale (NPS)
Time frame: Day1
Analysis of clinical factors associated with the severity of dysmenorrhea (Body Mass Index (BMI)) using Numerical Pain Scale (NPS)
Time frame: Day1
Analysis of clinical factors associated with the severity of dysmenorrhea (age of onset of dysmenorrhea,) using Numerical Pain Scale (NPS)
Time frame: Day1
Analysis of clinical factors associated with the severity of dysmenorrhea (presence of associated menorrhagia) using Numerical Pain Scale (NPS)
Time frame: Day1
Analysis of clinical factors associated with the severity of dysmenorrhea (medical history) using Numerical Pain Scale (NPS)
Time frame: Day1
Study of the prevalence of gynaecological conditions (menorrhagia)
Time frame: Day 1
Study of the prevalence of gynaecological conditions (endometriosis)
Time frame: Day 1
Study of the prevalence of gynaecological conditions (adenomyosis)
Time frame: Day 1
Study of the prevalence of gynaecological conditions (PolyCystic ovary syndrome (PCOS))
Time frame: Day 1
Study of the prevalence of gynaecological conditions (abnormal cervical smear)
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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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.
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 Ehlers-Danlos Syndrome (EDS), run by University Hospital, Rouen at 1 site in France.
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 4 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: looking for participants now, as of the sponsor's last update on 10 Jun 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathilde ML LECOINTRE, Doctor (02 32 88 07 89 ext. +33, melodie.lecointre@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the severity of dysmenorrhea by Numerical Pain Scale (NPS) (time frame: Day 1). 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 10 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.