NCT07036666

A Study Assessing the Impact of a Women's Health Formulation on Vaginal Health and the Microbial Community

An Open Label Study Assessing the Impact of a Women's Health Formulation on Vaginal Health and the Microbial Community

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Radicle Science · Industry
• Sex: Female
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

An open label study assessing the impact of a women's health formulation on vaginal health and the microbial community

Detailed description

This is an open label study conducted with adult participants, assigned female at birth, residing in the United States. Eligible participants will (1) endorse a desire for better vaginal health and (2) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome. Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded. Self-reported data are collected electronically from eligible participants over 5 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Conditions

• Women's Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Active Product	Women's (vaginal) Health Active Product

Timeline

• Start date: 2025-07-08
• Primary completion: 2025-10-02
• Completion: 2025-10-02
• First posted: 2025-06-25
• Last updated: 2025-11-03

Locations

1 site across 1 country: United States