NCT06646185 Improving Menstrual and VAginal Health for All
| NCT ID | NCT06646185 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Swiss Tropical & Public Health Institute |
| Condition | Effects of Menstrual Products on the Vaginal Microbiome |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-04-15 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-04-15 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Sonja Merten, PhD
PRINCIPAL INVESTIGATOR
Swiss Tropical & Public Health Institute
Frequently Asked Questions
Who can join the NCT06646185 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 35 Years, studying Effects of Menstrual Products on the Vaginal Microbiome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06646185 currently recruiting?
Yes, NCT06646185 is actively recruiting participants. Contact the research team at sonja.merten@swisstph.ch for enrollment information.
Where is the NCT06646185 trial being conducted?
This trial is being conducted at Yaoundé, Cameroon, Iquitos, Peru, Allschwil, Switzerland.
Who is sponsoring the NCT06646185 clinical trial?
NCT06646185 is sponsored by Swiss Tropical & Public Health Institute. The principal investigator is Sonja Merten, PhD at Swiss Tropical & Public Health Institute. The trial plans to enroll 100 participants.