Impact of Internal Menstrual Protections on Immunity and Vaginal Microbiota

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.

NCT Number	NCT07199998
Lead Sponsor	Centre National de la Recherche Scientifique, France Collaborators: Institut Alfred Fournier
Conditions	Sexual Transmitted Disease, Vaginosis, Bacterial, Mycosis, Urogenital Disease, HPV, Dysbiosis, Toxic Shock Syndrome, Menstrual Cup
Enrollment	300 participants
Start Date	2026-04-07
Primary Completion	2027-03 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2026-04-09