NCT07199998 Impact of Internal Menstrual Protections on Immunity and Vaginal Microbiota
| NCT ID | NCT07199998 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre National de la Recherche Scientifique, France |
| Condition | Sexual Transmitted Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-04-07 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2026-04-07 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Samuel Alizon, Doctor in Biology
PRINCIPAL INVESTIGATOR
Centre National de la Recherche Scientifique, France
Frequently Asked Questions
Who can join the NCT07199998 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 49 Years, studying Sexual Transmitted Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07199998 currently recruiting?
Yes, NCT07199998 is actively recruiting participants. Contact the research team at samuel.alizon@cnrs.fr for enrollment information.
Where is the NCT07199998 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT07199998 clinical trial?
NCT07199998 is sponsored by Centre National de la Recherche Scientifique, France. The principal investigator is Samuel Alizon, Doctor in Biology at Centre National de la Recherche Scientifique, France. The trial plans to enroll 300 participants.