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RECRUITING
NCT07199998

Impact of Internal Menstrual Protections on Immunity and Vaginal Microbiota

Sponsor: Centre National de la Recherche Scientifique, France

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 49 Years

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2026-04-07

Completion Date

2027-03

Last Updated

2026-04-09

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Institut Alfred Fournier

Paris, Île-de-France Region, France