About this trial
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.
Eligibility criteria
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Menstrual Pads
- Menstrual Cups
- Tampons
Treatment groups
6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Swiss Tropical & Public Health Institute
Lead sponsor
Universidad Nacional de la Amazonia Peruana
Collaborator
Universidad Peruana Cayetano Heredia
Collaborator
Centre de Recherche sur les Maladies Emergentes et Re-Emergentes
Collaborator
Universiteit Antwerpen
Collaborator