NCT07435350

A Trial to Assess the Pharmacokinetics and Pharmacodynamics of a Novel Synbiotic Oral Supplement for Vaginal Health

A Randomized, Placebo-Controlled Trial to Assess the Pharmacokinetics and Pharmacodynamics of a Novel Synbiotic Oral Supplement for Vaginal Health

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Radicle Science · Industry
• Sex: Female
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A randomized, placebo-controlled trial to assess the Pharmacokinetics and Pharmacodynamics of a novel synbiotic dietary supplement for vaginal health.

Detailed description

This is a randomized, double-blind, placebo-controlled, decentralized clinical trial that will enroll approximately 200 healthy women aged 21-60 years old who meet all eligibility criteria. Eligible participants will be stratified based on key factors. Following stratification, participants will be randomized to one of the study arms (placebo or VV-01 product) using block randomization. Participants will have a 1:1 chance of receiving the active study product or the placebo. Participants will receive study kits containing the study product, administration supplies, biomarker self-collection materials, and comprehensive instructions for product use and sample collection. The duration of the study for each participant will be approximately 2 weeks following enrollment.

Conditions

• Vaginal Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vaginal Health Placebo Control	Vaginal Health Placebo Control Participants will orally ingest Vaginal Health Placebo Control once daily as directed for a period of 2 weeks
DIETARY_SUPPLEMENT	Vaginal Health Active VV-01	Product 1 Participants will orally ingest Vaginal Health Active Product 1 once daily as directed for a period of 2 weeks.

Timeline

• Start date: 2026-02-26
• Primary completion: 2027-02-26
• Completion: 2027-02-26
• First posted: 2026-02-27
• Last updated: 2026-03-12

Locations

1 site across 1 country: United States