NCT06646185

Improving Menstrual and VAginal Health for All

IMVAHA: Improving Menstrual and VAginal Health for All

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Swiss Tropical & Public Health Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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

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

• Effects of Menstrual Products on the Vaginal Microbiome

Interventions

Type	Name	Description
OTHER	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.
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.
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2024-10-17
• Last updated: 2026-01-08

Locations

3 sites across 3 countries: Cameroon, Peru, Switzerland