How menstrual cups, tampons, and pads affect vaginal microbiota and immunity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The project combines a large online survey of 1,500–1,800 participants about menstrual product habits and self-reported urogenital symptoms with a clinical study of about 300 women grouped by primary menstrual protection (menstrual cup, tampon, or external pad). Clinical participants will undergo gynecological exams and provide vaginal, cervical, urine, and blood samples for microbiome sequencing, immune profiling (cytokines and antibodies), and toxicological assays for environmental pollutants. Analyses will compare microbial composition, local immune markers, and exposure levels across product groups and correlate findings with infection history and symptoms. The work is led by the CNRS in collaboration with Institut Alfred Fournier in Paris.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* Willing to sign a written informed consent form.
* Has already experienced menstruation prior to the start of the study.
* No vaginal sexual intercourse within 72 hours before the study visit.
* Has had at least 6 menstrual periods in the past 12 months.

Exclusion Criteria:

* 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.
* Pregnancy or breastfeeding.
* Family members or close relatives of the clinical or scientific team.
* Treatment with any medication for chronic inflammatory disease or chronic conditions (e.g., cancer, arthritis, transplantation) within the past 12 months.
* Participation in an ongoing clinical trial.
* Receiving or having received antibiotic treatment within the 4 weeks prior to the study.
* Refusal to be informed in case of detected abnormalities.
* Indistinct use of both tampons and menstrual cups.
* Never having had vaginal penetrative intercourse.

Where it's running

• Institut Alfred Fournier
  Paris, Île-de-France Region, France Recruiting

Study contacts

• Principal investigator: Samuel Alizon, Doctor in Biology — Centre National de la Recherche Scientifique, France
• Study coordinator: Samuel Alizon, Dr
• Email: samuel.alizon@cnrs.fr
• Phone: +33(4)144271667

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.