Multiple SclerosisGYNESEPNCT05248438
Study of Gynecological Follow-up Concerning Women With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The investigators want to evaluate gynecological follow-up concerning patients with multiple sclerosis. This study will include reproductive women (from 18 to 40 years old). Patients in the study have an aftercare at the neurology department at Pellegrin Hospital (Bordeaux). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 192 participants
- Where
- 1 siteFrance
- Study dates
- 11 May 2022to 9 May 2023
- 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 18 to 40 years
- Women only
- Adult
Study population: Patient Aged between 18 to 40 years old, affected by multiple sclerosis based on McDonald Criteria 2017
Who may be able to join
- Aged between 18 to 40 years old ;
- Diagnosis of multiple sclerosis based on McDonald Criteria 2017 ;
- Patient whose clinical data are referenced in the European Database for Multiple Sclerosis (EDMUS) clinical database (OFSEP database for collecting clinical data from patients followed in the neurology department) ;
- French-speaking, without comprehension disorders ;
- being affiliated to health insurance ;
- Willing to participate and to sign informed consent.
Who cannot join
- pregnant or breastfeeding women ;
- patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).
Trial locations and contacts
1 site in 1 country.
About this study
The investigators want to evaluate gynecological follow-up concerning patients with multiple sclerosis. This study will include reproductive women (from 18 to 40 years old). Patients in the study have an aftercare at the neurology department at Pellegrin Hospital (Bordeaux).
Read the detailed description
Multiple sclerosis is an inflammatory disease of central nervous system, with a prevalence rate in France of 1 case/1000 subjects (120 000 subjects in France). The average age at diagnosis is 30 years old and it affects especially women, with a sex ratio of 3 women for 1 man.
Many different treatments exist, depending on the severity of the pathology and the evolutivity of the disease. It is very important to understand that some treatments are not compatible with pregnancy. In these circumstances, a regular gynecological follow-up seems to be essential, to discuss contraception and pregnancy. Besides, some treatments have an immunosuppressive activity that is why a gynecological aftercare is necessary, especially in the detection of papillomavirus for cervical cancer.
The neurologist can advise about gynecological issues, but he cannot take care of the gynecological follow-up, that is why it is very interesting to study the quality of the gynecological follow-up. The investigators aim to study gynecological care of patients with multiple sclerosis using a questionnaire made especially for this project. The questionnaire will be filled by patients when they come in the neurology department for a consultation or during their visit at day hospital. At the same time, they will fill a standardized questionnaire about sexuality and quality of life.
This project is a monocentric study realized at Pellegrin Hospital - Bordeaux. Patients with multiple sclerosis belong to a cohort of the neurology center (CRCSEP).
- Conditions
- Multiple Sclerosis
- Being tested
- Questionnaire
- Keywords
- multiple sclerosis, gynecological care, sexuality, contraception
- Medical subject headings
- Multiple Sclerosis, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Multiple sclerosis patients | patients affected by multiple sclerosis based on McDonald Criteria 2017 Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gynecological scores of women from 18 to 40 years old with multiple sclerosis with a standardized questionnaire created for the study.
17 questions concerning contraception, number of gynecological follow up, frequency of cervical cancer screening, desire of pregnancy.
Measured: At baseline (Day 0)
Secondary outcomes (4)
Proportion of patients affected by SEP with an Impact on sexuality according to Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19).
that varies between 19 and 95 with higher values mean higher levels of Impact on sexuality
Measured: At baseline (Day 0)
Proportion of patients affected by SEP with an impact on life quality according to Fatigue severity Scale (FFS).
that varies between 9 and 63 with higher values mean higher levels of Impact on life quality
Measured: At baseline (Day 0)
Proportion of patients affected by SEP with an impact on life quality according to EHD scores ("échelle d'humeur dépressive" in french)
that varies between 11 and 44 with higher values mean higher levels of Impact on life quality
Measured: At baseline (Day 0)
Proportion of patients affected by SEP with an impact on life quality according to Multiple Sclerosis Quality of life (MusiQol) scores
that varies between 31 and 155 with higher values mean higher levels of Impact on life quality
Measured: At baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start11 May 2022
- Primary completion9 May 2023
- Study completion9 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Valérie BERNARD, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248438
- Sponsor's protocol ID
- CHUBX 2021/49
- Acronym
- GYNESEP
- Status last verified
- Jun 2023
- First submitted
- 11 Feb 2022
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Renaud J, Buissonniere P, Dulau C, Deloire M, Hontarrede F, Montcuquet A, Chansel-Debordeaux L, Hocke C, Ouallet JC, Ruet A, Bernard V. Gynaecological follow-up for women of reproductive age with multiple sclerosis: The GYNESEP study. Mult Scler Relat Disord. 2024 Mar;83:105448. doi: 10.1016/j.msard.2024.105448. Epub 2024 Jan 14.
PubMed 38277979
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Gynecological Follow-up Concerning Women With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05248438
- Acronym / sponsor ID
- GYNESEP / CHUBX 2021/49
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, gynecological care, sexuality, contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 11 May 2022 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 21 Feb 2022 (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.
The investigators want to evaluate gynecological follow-up concerning patients with multiple sclerosis. This study will include reproductive women (from 18 to 40 years old). Patients in the study have an aftercare at the neurology department at Pellegrin Hospital (Bordeaux).
Detailed description
Multiple sclerosis is an inflammatory disease of central nervous system, with a prevalence rate in France of 1 case/1000 subjects (120 000 subjects in France). The average age at diagnosis is 30 years old and it affects especially women, with a sex ratio of 3 women for 1 man.
Many different treatments exist, depending on the severity of the pathology and the evolutivity of the disease. It is very important to understand that some treatments are not compatible with pregnancy. In these circumstances, a regular gynecological follow-up seems to be essential, to discuss contraception and pregnancy. Besides, some treatments have an immunosuppressive activity that is why a gynecological aftercare is necessary, especially in the detection of papillomavirus for cervical cancer.
The neurologist can advise about gynecological issues, but he cannot take care of the gynecological follow-up, that is why it is very interesting to study the quality of the gynecological follow-up. The investigators aim to study gynecological care of patients with multiple sclerosis using a questionnaire made especially for this project. The questionnaire will be filled by patients when they come in the neurology department for a consultation or during their visit at day hospital. At the same time, they will fill a standardized questionnaire about sexuality and quality of life.
This project is a monocentric study realized at Pellegrin Hospital - Bordeaux. Patients with multiple sclerosis belong to a cohort of the neurology center (CRCSEP).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis patients | – | Behavioral: Questionnairepatients affected by multiple sclerosis based on McDonald Criteria 2017 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patient Aged between 18 to 40 years old, affected by multiple sclerosis based on McDonald Criteria 2017
Key inclusion criteria (6 listed)
- Aged between 18 to 40 years old ;
- Diagnosis of multiple sclerosis based on McDonald Criteria 2017 ;
- Patient whose clinical data are referenced in the European Database for Multiple Sclerosis (EDMUS) clinical database (OFSEP database for collecting clinical data from patients followed in the neurology department) ;
- French-speaking, without comprehension disorders ;
- being affiliated to health insurance ;
Key exclusion criteria (2 listed)
- pregnant or breastfeeding women ;
- patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire | Behavioural | Multiple sclerosis patients |
Primary outcome
Gynecological scores of women from 18 to 40 years old with multiple sclerosis with a standardized questionnaire created for the study.
Time frame: At baseline (Day 0)
17 questions concerning contraception, number of gynecological follow up, frequency of cervical cancer screening, desire of pregnancy.
4 secondary outcomes
Proportion of patients affected by SEP with an Impact on sexuality according to Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19).
Time frame: At baseline (Day 0)
Proportion of patients affected by SEP with an impact on life quality according to Fatigue severity Scale (FFS).
Time frame: At baseline (Day 0)
Proportion of patients affected by SEP with an impact on life quality according to EHD scores ("échelle d'humeur dépressive" in french)
Time frame: At baseline (Day 0)
Proportion of patients affected by SEP with an impact on life quality according to Multiple Sclerosis Quality of life (MusiQol) scores
Time frame: At baseline (Day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Derived from this study: PubMed 38277979Renaud J, Buissonniere P, Dulau C, Deloire M, Hontarrede F, Montcuquet A, Chansel-Debordeaux L, Hocke C, Ouallet JC, Ruet A, Bernard V. Gynaecological follow-up for women of reproductive age with multiple sclerosis: The GYNESEP study. Mult Scler Relat Disord. 2024 Mar;83:105448. doi: 10.1016/j.msard.2024.105448. Epub 2024 Jan 14.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
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.
Valérie BERNARD, MD principal investigator
University Hospital, Bordeaux
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 Multiple Sclerosis, run by University Hospital, Bordeaux 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 12 Jun 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gynecological scores of women from 18 to 40 years old with multiple sclerosis with a standardized questionnaire created for the study. (time frame: At baseline (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05248438, which also lists 1 linked publication.
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 12 Jun 2023.