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NCT07109869 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Boric Acid Inserts for Treatment of Vulvovaginal Candidiasis
A Phase 3 study of Vulvovaginal Candidiasis (VVC) and Vulvovaginal Candidiases, sponsored by pH-D Feminine Health.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT07109869: Recruiting Phase 3 study of Vulvovaginal Candidiasis (VVC) and Vulvovaginal Candidiases, sponsored by pH-D Feminine Health.
NCT07109869 is a Phase 3 study of Vulvovaginal Candidiasis (VVC) and Vulvovaginal Candidiases that is actively recruiting participants, run by pH-D Feminine Health. The registered enrollment target is 400 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07109869, a Phase 3 study of Vulvovaginal Candidiasis (VVC) and Vulvovaginal Candidiases, is actively recruiting participants, sponsored by pH-D Feminine Health.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 3 clinical study to evaluate the efficacy, safety, and tolerability of boric acid 600 mg vaginal inserts in patients with VVC.
Primary Outcome
The proportion of patients who achieve clinical cure (defined as the absence of all signs and symptoms of vulvovaginal candidiasis (VVC) \[ie, composite VSS score = 0\] in the absence of additional antifungal treatment), at the test-of-cure (TOC) visit. This is the proportion of patients in the modified ITT (mITT) Population with clinical cure. * Signs: vulvovaginal edema, erythema, excoriation/fissures; * Symptoms: vulvovaginal itching, burning, irritation; and * Severity of each sign and symp
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Boric acid
Study Locations (20)
Florida
- Project 4 Research Inc - Miami
- Entrust Clinical Research - Miami
- Felicidad Medical Research, LLC - Miami
- Better Life Clinical Research, LLC - Tampa
- Helping Hands Health Center - Tampa
North Carolina
- Cross Creek Medical Clinic, PA - Fayetteville
- Unified Women's Clinical Research - Raleigh - Raleigh
- Unified Women's Clinical Research - Lyndhurst Clinical Research - Winston-Salem
California
- Century Research Institute, Inc - Huntington Park
- Matrix Clinical Research - Los Angeles
Louisiana
- Clinical Trials Management, LLC - Northshore - Covington
- Praetorian Pharmaceutical Research - Marrero
Texas
- TMC Life Research, Inc - Houston
- SMS Clinical Research, LLC - Mesquite
Alabama
- Alliance for Multispecialty Research - Mobile - Mobile
Arizona
- Abby's Research Institute - Phoenix
Idaho
- Leavitt Clinical Research - Idaho Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2025-08-08 |
| Est. Completion | 2026-06 |
| Phase | Phase 3 |
What NCT07109869 shows while recruiting
NCT07109869 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
The record links to 3 conditions, with Vulvovaginal Candidiasis (VVC) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07109869 names 20 study sites across 11 states, led by Florida, North Carolina, California.
Frequently Asked Questions
What is clinical trial NCT07109869 about?
NCT07109869 is a clinical study titled "Safety and Efficacy of Boric Acid Inserts for Treatment of Vulvovaginal Candidiasis". This is a Phase 3 clinical study to evaluate the efficacy, safety, and tolerability of boric acid 600 mg vaginal inserts in patients with VVC.
What is the current status of trial NCT07109869?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2025-08-08. Estimated completion is 2026-06.
What conditions does trial NCT07109869 study?
This clinical trial studies the following conditions: Vulvovaginal Candidiasis (VVC), Vulvovaginal Candidiases, Vulvovaginal Candidiasis, Genital.
What interventions are being tested in trial NCT07109869?
The interventions under investigation include: Placebo (OTHER), Boric acid (DRUG).
Who is sponsoring clinical trial NCT07109869?
This trial is sponsored by pH-D Feminine Health, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07109869 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Vulvovaginal Candidiasis (VVC)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07109869's enrollment target sits among peer trials
400 923rd of 2000 higher than 1,039 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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