Actively Recruiting

Age: 18Years - 49Years
FEMALE
Healthy Volunteers
NCT07199998

Impact of Internal Menstrual Protections on Immunity and Vaginal Microbiota

Led by Centre National de la Recherche Scientifique, France · Updated on 2026-04-09

300

Participants Needed

1

Research Sites

46 weeks

Total Duration

On this page

Sponsors

C

Centre National de la Recherche Scientifique, France

Lead Sponsor

I

Institut Alfred Fournier

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Impact of Internal Menstrual Protections on Immunity and Vaginal Microbiota

Who Can Participate

Age: 18Years - 49Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 based on medical history
  • Covered by the national health insurance system
  • Willing to sign a written informed consent form
  • Has experienced menstruation before 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
Not Eligible

You will not qualify if you...

  • HIV infection
  • Positive diagnosis for chlamydia or syphilis at screening or within 4 weeks prior
  • 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 medication for chronic inflammatory or chronic conditions in past 12 months
  • Participation in an ongoing clinical trial
  • Antibiotic treatment within 4 weeks prior to the study
  • Refusal to be informed of detected abnormalities
  • Indistinct use of both tampons and menstrual cups
  • Never had vaginal penetrative intercourse

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Institut Alfred Fournier

Paris, Île-de-France Region, France, 75014

Actively Recruiting

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Research Team

S

Samuel Alizon, Dr

CONTACT

C

Clinical team

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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