Study Results
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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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2026-01-31
2026-12-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
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).
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.
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.
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.
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).
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.
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.
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.
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).
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.
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.
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.
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).
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.
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.
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.
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).
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
35 Years
FEMALE
Yes
Sponsors
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Universidad Nacional de la Amazonia Peruana
UNKNOWN
Universidad Peruana Cayetano Heredia
OTHER
Centre de Recherche sur les Maladies Emergentes et Re-Emergentes
UNKNOWN
Universiteit Antwerpen
OTHER
Swiss Tropical & Public Health Institute
OTHER
Responsible Party
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Sonja Merten
Head of Unit Society, Gender and Health
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
Universidad Nacional de la Amazonia Peruana
Iquitos, Iquitos, Peru
Swiss Tropical and Public Health Institute
Allschwil, Allschwil, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-30
Identifier Type: -
Identifier Source: org_study_id
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