Clinical Trial

Safety and Efficacy of Boric Acid Inserts for Treatment of Vulvovaginal Candidiasis

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated August 3, 2026 (before its estimated August 13, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 7 changes
critical Enrollment closed, study ongoing 2026-08-04
notable Enrollment reduced: 400 -> 333 participants 2026-08-04
notable Primary completion pushed: 2026-07 -> 2026-08-13 2026-08-04
minor Completion pushed: 2026-07 -> 2026-08-13 2026-08-04
notable Trial sites expanded: 21 -> 27 locations 2026-04-03
notable Primary completion pushed: 2026-06 -> 2026-07 2026-04-03
minor Completion pushed: 2026-06 -> 2026-07 2026-04-03
Trial Details
NCT Number NCT07109869
Lead Sponsor pH-D Feminine Health LLC
Conditions Vulvovaginal Candidiases, Vulvovaginal Candidiasis, Genital, Vulvovaginal Candidiasis (VVC)
Enrollment 333 participants
Start Date 2025-08-08
Primary Completion 2026-08-13 (estimated)
Study Completion 2026-08-13 (estimated)
Updated on ClinicalTrials.gov 2026-08-03