Skip to main content
OpenTrials
Completed

NCT Number: NCT05248438

Study of Gynecological Follow-up Concerning Women With Multiple Sclerosis

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Sexual Behavior Sexuality

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

CHU de Bordeaux - service de neurologie

Bordeaux, France

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Questionnaire

Behavioral

Questionnaire

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

    that varies between 19 and 95 with higher values mean higher levels of Impact on sexuality

  2. Proportion of patients affected by SEP with an impact on life quality according to Fatigue severity Scale (FFS).

    Time frame: At baseline (Day 0)

    that varies between 9 and 63 with higher values mean higher levels of Impact on life quality

  3. 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)

    that varies between 11 and 44 with higher values mean higher levels of Impact on life quality

  4. 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)

    that varies between 31 and 155 with higher values mean higher levels of Impact on life quality

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Acronym: GYNESEP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2022
Registry last updated
Jun 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.