Improving Menstrual and VAginal Health for All

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorSwiss Tropical & Public Health Institute

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

100 Participants
are divided into 6 treatment groups

6

Treatment groups

See 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