Impact of Internal Menstrual Protections on Immunity and Vaginal Microbiota
Recruiting now
Conditions studied: Sexual Transmitted Disease, Vaginosis, Bacterial, Mycosis, Urogenital Disease, HPV, Dysbiosis, Toxic Shock Syndrome, Menstrual Cup
In brief
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.
Key facts
- Study ID
- NCT07199998
- Run by
- Centre National de la Recherche Scientifique, France
- People needed
- 300
- Starts
- 2026-04-07
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-04-09
Who can join
Age: 18 and older, up to 49. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Institut Alfred Fournier — Paris, Île-de-France Region, France (enrolling)
Full record on ClinicalTrials.gov
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