Improving Menstrual and VAginal Health for All (NCT06646185) | Clinical Trial Compass
RecruitingNot Applicable
Improving Menstrual and VAginal Health for All
Cameroon, Peru, Switzerland100 participantsStarted 2026-04-15
Plain-language 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.
Who can participate
Age range
18 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 recruitmen…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Log-ratio of Dialister to Lactobacillus crispatus relative abundances in vaginal swabs (continuous variable)
Timeframe: Monthly, after menstruation ends, through study completion, an average of 6 months.