Improving Menstrual and VAginal Health for All

NCT ID: NCT06646185

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-12-31

Brief Summary

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A three-period crossover trial will study the effects of short-term use of 3 menstrual products (menstrual pad, tampon, menstrual cup) on the bacterial composition of the vaginal microbiome in three countries (Peru, Cameroon, and Switzerland). Each crossover period consists of two menstrual cycles, thus resulting in a 6-month trial. Participants will be randomly assigned to one of 6 exposure sequences (different order of products per sequence); in each sequence, participants will adopt each menstrual product for 2 menstrual cycles. Participants will provide vaginal microbiome samples via self-sample swabs at 3 points during each menstrual cycle. Given the crossover design of the study, there is not a dedicated control group.

Detailed Description

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In three countries, the investigators will follow a randomized crossover design to study the effects of menstrual products on the vaginal microbiome composition and diversity. Eligible participants who are willing to adopt pads, tampons and menstrual cups to manage their menstruation, and for which baseline composition of their vaginal microbiomes is determined through DNA sequencing of the 16s rRNA gene will enter a three-period crossover trial. Each period of the trial will consist of two menstrual cycles, thus resulting in a 6-month trial. Participants will be randomly assigned to one of six different exposure sequences of menstrual products, as follows:

i) Tampon, Cup, Pad ii) Tampon, Pad, Cup iii) Cup, Tampon, Pad iv) Cup, Pad, Tampon v) Pad, Tampon, Cup vi) Pad, Cup, Tampon

In group "i)", participants will adopt tampons during the first two menstrual cycles (first period of the trial), followed by the adoption of cups during the next two menstrual cycles (second period), and lastly menstrual pads for the next two menstrual cycles (third crossover period). In groups ii) to vi) following the same design but in different sequences. Self-sampling kits will be provided during six consecutive menstrual cycles, a few days before the start of menses. Each kit will contain swabs for three self-sampling points during the menstrual cycle and the corresponding menstrual products.

Conditions

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Effects of Menstrual Products on the Vaginal Microbiome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A three-period crossover trial will study the effects of short-term use of 3 menstrual products (menstrual pad, tampon, menstrual cup) on the bacterial composition of the vaginal microbiome in three countries (Peru, Cameroon, and Switzerland). Each crossover period consists of two menstrual cycles, thus resulting in a 6-month trial. Participants will be randomly assigned to one of 6 exposure sequences (different order of products per sequence); in each sequence, participants will adopt each menstrual product for 2 menstrual cycles. Participants will provide vaginal microbiome samples via self-sample swabs at 3 points during each menstrual cycle. Given the crossover design of the study, there is not a dedicated control group. No wash-out period is included because participants can not stop the use of menstrual products to manage their menstruation.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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TamponCupPad

Participants will adopt tampons during the first two menstrual cycles (first period of the trial), followed by adoption of cups during the next two menstrual cycles (second period), and lastly menstrual pads for the next two menstrual cycles (third crossover period).

Group Type OTHER

Menstrual Pads

Intervention Type OTHER

Participants adopt menstrual pads to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.

Menstrual Cups

Intervention Type OTHER

Participants adopt menstrual cups to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.

Tampons

Intervention Type OTHER

Participants adopt tampons to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.

TamponPadCup

Participants will adopt tampons during the first two menstrual cycles (first period of the trial), followed by adoption of pads during the next two menstrual cycles (second period), and lastly menstrual cups for the next two menstrual cycles (third crossover period).

Group Type OTHER

Menstrual Pads

Intervention Type OTHER

Participants adopt menstrual pads to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.

Menstrual Cups

Intervention Type OTHER

Participants adopt menstrual cups to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.

Tampons

Intervention Type OTHER

Participants adopt tampons to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.

CupTamponPad

Participants will adopt menstrual cups during the first two menstrual cycles (first period of the trial), followed by adoption of tampons during the next two menstrual cycles (second period), and lastly menstrual pads for the next two menstrual cycles (third crossover period).

Group Type OTHER

Menstrual Pads

Intervention Type OTHER

Participants adopt menstrual pads to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.

Menstrual Cups

Intervention Type OTHER

Participants adopt menstrual cups to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.

Tampons

Intervention Type OTHER

Participants adopt tampons to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.

CupPadTampon

Participants will adopt menstrual cups during the first two menstrual cycles (first period of the trial), followed by adoption of menstrual pads during the next two menstrual cycles (second period), and lastly tampons for the next two menstrual cycles (third crossover period).

Group Type OTHER

Menstrual Pads

Intervention Type OTHER

Participants adopt menstrual pads to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.

Menstrual Cups

Intervention Type OTHER

Participants adopt menstrual cups to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.

Tampons

Intervention Type OTHER

Participants adopt tampons to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.

PadTamponCup

Participants will adopt menstrual pads during the first two menstrual cycles (first period of the trial), followed by adoption of tampons during the next two menstrual cycles (second period), and lastly menstrual cups for the next two menstrual cycles (third crossover period).

Group Type OTHER

Menstrual Pads

Intervention Type OTHER

Participants adopt menstrual pads to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.

Menstrual Cups

Intervention Type OTHER

Participants adopt menstrual cups to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.

Tampons

Intervention Type OTHER

Participants adopt tampons to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.

PadCupTampon

Participants will adopt menstrual pads during the first two menstrual cycles (first period of the trial), followed by adoption of menstrual cups during the next two menstrual cycles (second period), and lastly tampons for the next two menstrual cycles (third crossover period).

Group Type OTHER

Menstrual Pads

Intervention Type OTHER

Participants adopt menstrual pads to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.

Menstrual Cups

Intervention Type OTHER

Participants adopt menstrual cups to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.

Tampons

Intervention Type OTHER

Participants adopt tampons to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.

Interventions

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Menstrual Pads

Participants adopt menstrual pads to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.

Intervention Type OTHER

Menstrual Cups

Participants adopt menstrual cups to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.

Intervention Type OTHER

Tampons

Participants adopt tampons to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* able to provide informed consent;
* aged 18-35;
* residing in the recruitment region and expecting to reside in the same region for at least six months following recruitment (Yaoundé/ Gounougou, Cameroon; Loreto/Lima/Maynas provinces, Peru; or Basel-Landschaft and Basel-Stadt cantons, Switzerland);
* are native speakers or are able to read and understand one of the following languages in each respective country (German, French, Italian, English or Spanish in Switzerland; French or English in Cameroon; Spanish in Peru);
* had menstrual cycles of 21-35 days for at least the last 4 months;
* had menses which lasted at least 3 days for at least the last 4 months.

Exclusion Criteria

* experienced a menstrual abnormality with any of the menstrual cycles in the last 4 months (such as oligomenorrhea or amenorrhea, or bleed more than 7 days a month);
* are pregnant or actively trying to become pregnant;
* are breastfeeding;
* used antibiotics and/or vaginal antifungals in the last 30 days prior to recruitment;
* had a vaginal birth in the last 6 months;
* vaginal surgery, perineal surgery, uterine surgery, miscarriage or abortion in the last 6 months;
* history of Toxic Shock Syndrome ;
* positive to detection of the toxic shock syndrome toxin-1 gen (tst) using Polymerase Chain Reaction (PCR);
* Intrauterine device in situ;
* under medication (treatment against infectious or chronic disease) at the time of recruitment or during the 3 weeks prior to recruitment;
* clinical symptoms of vaginal infection;
* smoker.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Nacional de la Amazonia Peruana

UNKNOWN

Sponsor Role collaborator

Universidad Peruana Cayetano Heredia

OTHER

Sponsor Role collaborator

Centre de Recherche sur les Maladies Emergentes et Re-Emergentes

UNKNOWN

Sponsor Role collaborator

Universiteit Antwerpen

OTHER

Sponsor Role collaborator

Swiss Tropical & Public Health Institute

OTHER

Sponsor Role lead

Responsible Party

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Sonja Merten

Head of Unit Society, Gender and Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sonja Merten, PhD

Role: PRINCIPAL_INVESTIGATOR

Swiss Tropical & Public Health Institute

Locations

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Centre de Recherche sur les Maladies Emergentes et Re-Emergentes

Yaoundé, Yaoundé, Cameroon

Site Status

Universidad Nacional de la Amazonia Peruana

Iquitos, Iquitos, Peru

Site Status

Swiss Tropical and Public Health Institute

Allschwil, Allschwil, Switzerland

Site Status

Countries

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Cameroon Peru Switzerland

Central Contacts

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Sonja Merten, MD MPH PhD

Role: CONTACT

0041-61-284-8387

Monica Ticlla, PhD

Role: CONTACT

0041-61-284-8387

Facility Contacts

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Esemu Livo, PhD

Role: primary

+237 674 632 078

Marie Josiane Kenfack, PhD(c)

Role: backup

+237676783165

Viviana Pinedo, PhD

Role: primary

+51 955 850 853

Sandra Condori, PhD

Role: backup

+32 488 15 54 52

Sonja Merten, MD MPH PhD

Role: primary

+41 79 640 17 27

Monica Ticlla, PhD

Role: backup

Other Identifiers

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2023-30

Identifier Type: -

Identifier Source: org_study_id

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