An observational study in Sexual Transmitted Disease, Vaginosis, Bacterial and Mycosis, sponsored by Centre National de la Recherche Scientifique, France. Recruiting at 1 site in France. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Centre National de la Recherche Scientifique, France · Observational
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.
The aim of this study is to investigate potential links between the type of menstrual protection used and variations in vaginal health, including microbial composition, immune responses, and exposure to environmental pollutants.
The project consists of two complementary components:
- Epidemiological Study: An online survey will be conducted with 1,500 to 1,800 participants, collecting detailed information on the usage habits of menstrual protection products (such as menstrual cups, tampons, and external pads), as well as self-reported symptoms and history of urogenital infections. This dataset will allow for large-scale correlation analyses between menstrual hygiene practices and women's health indicators.
- Clinical Study:
A total of approximately 300 women will be recruited and divided into three groups based on their primary menstrual protection method:
Group 1: Menstrual cup users Group 2: Tampon users Group 3: External sanitary pad users
All clinical participants will undergo a gynecological examination and provide vaginal, cervical, urinary, and blood samples. These biological samples will be used for in-depth analysis across three main areas:
Sequencing, immune profiling, pollutant quantification, and cytobacteriological screening will be conducted to evaluate potential differences between groups. These analyses aim to provide a better understanding of how menstrual protection methods may influence vaginal ecosystem balance, immune activity, and overall urogenital health.
523 studies on the registry are indexed under Sexually Transmitted Diseases; 77 are open to participants now.
This study's planned enrollment of 300 is below the median of 576 across 92 observational studies indexed under Sexually Transmitted Diseases.
Browse Sexually Transmitted Diseases studies →Centre National de la Recherche Scientifique, France is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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The study population includes individuals of the female sex, aged 18 to 49 years, who have already experienced at least one menstrual period and meet the inclusion criteria. Participants are residents of the Île-de-France region and are recruited either through the Alfred Fournier Institute or via an online epidemiological survey.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group includes participants who have been using single-use tampons as their main form of menstrual protection in the past six months.
Other: Samples collection (whole blood, urine, vaginal and cervical cells)
This group includes participants who have used reusable menstrual cups as their main form of protection in the past six months.
Other: Samples collection (whole blood, urine, vaginal and cervical cells)
This group includes participants who have not used any internal menstrual products in the past six months, relying instead on external protection such as sanitary pads.
Other: Samples collection (whole blood, urine, vaginal and cervical cells)
During the clinical visit, samples will be collected from participants, including blood, urine, and vaginal and cervical cells. These samples will be used for a range of analyses, including determination of the vaginal microbiota composition and sequencing, cytokine profiling, and assessment of local immunity through flow cytometry using CyTOF technology. Urine samples will be analyzed for pollutants such as phthalates and bisphenol, while blood samples will be used for blood cell counts.
Determine the effect of the use of internal menstrual products on the composition of the vaginal microbiota.
To investigate potential differences in microbiota between study groups, the investigators will perform metagenomics next-generation sequencing on vaginal swabs.
Time frame: Samples will be stored at -80°C and metagenomics sequencing will be performed within 24 months after collection.
Comparison of the vaginal immune response of users and non-users of internal menstrual products
Description of the cellular composition from vaginal and cervical samples (CyTOF technique) and measurement of vaginal cytokines. Since this is a cross-sectional study, all the measures are made at inclusion, i.e. at baseline.
Time frame: Samples for this purpose will be prepared for preservation immediately after collection. After preparation, they will be stored at -80°C and subsequently shipped for the analyses.
Effect of the type of internal menstrual protections on the presence of pollutants in urine.
Quantification of parabens and other pollutants in urine samples or other samples.
Time frame: Urine samples will be stored at -80°C and analysed within 24 months after collection.
Associations between the type of menstrual hygiene product used and sexually transmitted infections (STIs)
Retrospective epidemiological analyses will be performed using statistical modelling on the questionnaires filled in at the inclusion visit.
Time frame: Statistical analyses will be performed after the last participant follow-up. They will be based on inclusion questionnaires. The time frame to evaluate the incidence of STIs will be the 12 months before inclusion.
Plan to share: Undecided — Participants who wish to be informed about the results of the research will receive information in French about the scientific publications via a newsletter or posts on social media (e.g. mastodon).
Started Apr 2026 (actual). Primary completion is estimated for Mar 2027, 11 months after the start.
Of 42 non-industry observational studies under Sexually Transmitted Diseases, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 57. This study's planned 11 months is below that.
Counting every sponsor, half of 47 studies reached it within 26 months; a quarter within 15 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
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Centre National de la Recherche Scientifique, France