Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 1:16 AM
Study NCT ID:
NCT07435350
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Assess the Pharmacokinetics and Pharmacodynamics of a Novel Synbiotic Oral Supplement for Vaginal Health
Sponsor:
Radicle Science
Organization:
Study Overview
Official Title:
A Randomized, Placebo-Controlled Trial to Assess the Pharmacokinetics and Pharmacodynamics of a Novel Synbiotic Oral Supplement for Vaginal Health
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: