RecruitingNot Applicable

Impact of Internal Menstrual Protections on Immunity and Vaginal Microbiota

France300 participantsStarted 2026-04-07

Plain-language summary

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.

Who can participate

Age range

18 Years – 49 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Determine the effect of the use of internal menstrual products on the composition of the vaginal microbiota.

Timeframe: Samples will be stored at -80°C and metagenomics sequencing will be performed within 24 months after collection.

Trial details

NCT IDNCT07199998

SponsorCentre National de la Recherche Scientifique, France

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-03

Contact for this trial

Samuel Alizon, Dr

+33(4)144271667 samuel.alizon@cnrs.fr

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