Safety and Efficacy of Boric Acid Inserts for Treatment of Vulvovaginal Candidiasis
Safety and Efficacy Study to Assess 600 mg Boric Acid Vaginal Inserts With 7- or 14-Days Treatment of Vulvovaginal Candidiasis (VVC)
pH-D Feminine Health LLC
400 participants
Aug 8, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Boric acid vaginal inserts consisting of 600 mg boric acid drug substance filled into white, opaque hypromellose capsules with no additional excipients included in the formulation. Each vaginal insert is sealed into a clear blister cavity.
Placebo vaginal inserts containing anhydrous lactose and 1% magnesium stearate are also manufactured and filled into white, opaque hypromellose capsules. Packaged in clear blisters.
Locations(27)
View Full Details on ClinicalTrials.gov
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NCT07109869