Status:
NOT_YET_RECRUITING
Impact of Internal Menstrual Protections on Immunity and Vaginal Microbiota
Lead Sponsor:
Centre National de la Recherche Scientifique, France
Collaborating Sponsors:
Institut Alfred Fournier
Conditions:
Sexual Transmitted Disease
Vaginosis, Bacterial
Eligibility:
FEMALE
18-49 years
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 soc...
Detailed Description
The aim of this study is to investigate potential links between the type of menstrual protection used and variations in vaginal health, including microbial composition, immune responses, and exposure ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07199998
Start Date
October 1 2025
End Date
November 1 2026
Last Update
September 30 2025
Active Locations (1)
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1
Institut Alfred Fournier
Paris, Île-de-France Region, France, 75014