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Improving Menstrual and VAginal Health for All

Study acronym: IMVAHA
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Primary completion pushed from Aug 2026 to Dec 31, 2026 · Completion pushed from Dec 2026 to Dec 31, 2026 · Start date changed from estimate of Jan 2026 to Apr 15, 2026 · 1 morev5 Show 4 more changesShow less
    • Primary completion pushed from Aug 2026 to Dec 31, 2026
    • Completion pushed from Dec 2026 to Dec 31, 2026
    • Start date changed from estimate of Jan 2026 to Apr 15, 2026
    • Site details revised at 3 of 3 sites
  2. Start date: Jul 2025 to Jan 2026 Primary endpoint revised · Primary completion date: Jul 2026 to Aug 2026 · Completion date: Jul 2026 to Dec 2026 · 2 morev4 Show 5 more changesShow less
    • Primary endpoint revised
    • Primary completion date: Jul 2026 to Aug 2026
    • Completion date: Jul 2026 to Dec 2026
    • Eligibility criteria expanded, about 52 words
    • Secondary endpoints: 8 to 11

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Mar 2025 to Jul 2025 Primary and study completion dates: Mar 2026 to Jul 2026 · Eligibility criteria revised · Site details revised at 3 of 3 sitesv3 Show 3 more changesShow less
    • Primary and study completion dates: Mar 2026 to Jul 2026
    • Eligibility criteria revised
    • Site details revised at 3 of 3 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Nov 2024 to Mar 2025 Site details revised at 3 of 3 sitesv2 Show 1 more changeShow less
    • Site details revised at 3 of 3 sites
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06646185
Lead Sponsor Swiss Tropical & Public Health Institute
Collaborators: Universidad Nacional de la Amazonia Peruana, Universidad Peruana Cayetano Heredia, Centre de Recherche sur les Maladies Emergentes et Re-Emergentes, Universiteit Antwerpen
Conditions Effects of Menstrual Products on the Vaginal Microbiome
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov