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Impact of the Use of Internal Menstrual Protections on Immunity and Vaginal Microbiota

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 49
Healthy Volunteers: t
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• 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.

Locations
Other Locations
France
Institut Alfred Fournier
RECRUITING
Paris
Contact Information
Primary
Samuel Alizon, Dr
samuel.alizon@cnrs.fr
+33(4)144271667
Backup
Clinical team
cups2@college-de-france.fr
Time Frame
Start Date: 2026-04-07
Estimated Completion Date: 2027-03
Participants
Target number of participants: 300
Treatments
Tampon-only user
This group includes participants who have been using single-use tampons as their main form of menstrual protection in the past six months.
Cups-only user
This group includes participants who have used reusable menstrual cups as their main form of protection in the past six months.
External-only user
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.
Related Therapeutic Areas
Sponsors
Collaborators: Institut Alfred Fournier
Leads: Centre National de la Recherche Scientifique, France

This content was sourced from clinicaltrials.gov