About this trial
The availability, effectiveness, and safety of menstrual protection represent a key public health issue. However, research on women's menstrual and sexual health remains extremely limited. Whether societal or pathological, many hypotheses are emerging regarding the effects of menstrual protection products, yet little attention has been given to the products themselves, their societal role, or their physiological and pathological consequences. Internal menstrual products, such as tampons and menstrual cups, are widely used but are subject to limited regulatory oversight, and few studies have investigated their long-term effects on vaginal health.
This study aims to investigate how different types of menstrual protection influence vaginal microbiota, immune responses, and the recurrence of gynecological conditions such as bacterial vaginosis, mycosis, or dysbiosis. Biological samples (vaginal, cervical, urinary, and blood) will be collected to analyze vaginal microbiota composition and local immunity. Participants will be divided into three groups based on their main type of menstrual protection: menstrual cup users, tampon users, and external pad users. The study will compare these groups to assess potential differences in vaginal health and immune response related to menstrual product use.
Eligibility criteria
Qualifiers
Willingness to comply with all study procedures and availability for the duration of the study.
Female, aged 18 to 49 years.
In general good health, as determined by medical history.
Covered by the national health insurance system.
Disqualifiers
HIV infection.
Positive diagnosis for chlamydia or syphilis at screening or within 4 weeks prior to screening.
History of hormonal disorders or menstrual cycle irregularities.
Metrorrhagia.
Trial design
Treatments tested in this trial
- Samples collection (whole blood, urine, vaginal and cervical cells)
Treatment groups
Sponsors and collaborators
Centre National de la Recherche Scientifique, France
Lead sponsor
Institut Alfred Fournier
Collaborator