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

Conditions

• Vulvovaginal Candidiases
• Vulvovaginal Candidiasis (VVC)
• Vulvovaginal Candidiasis, Genital

Eligibility Criteria

Sex

FEMALE

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Boric acid — DRUG
  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 — OTHER
  Placebo vaginal inserts containing anhydrous lactose and 1% magnesium stearate are also manufactured and filled into white, opaque hypromellose capsules. Packaged in clear blisters.

Study Details

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.

Key Dates

Start date

Aug 8, 2025

Status verified

Jun 2026

Primary completion

Jul 31, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 14 days 600 mg boric acid inserts
  All patients will self-administer 600 mg boric acid vaginal inserts once daily for 14 days.
• Experimental: 7 days 600 mg boric acid inserts followed by 7 days placebo inserts
  All patients will self-administer 600 mg boric acid vaginal inserts once daily for first 7 days and placebo vaginal inserts for following 7 days.
• Placebo Comparator: 14 days placebo inserts
  All patients will self-administer placebo vaginal inserts once daily for 14 days.

Primary Outcome Measure

Proportion of patients with the absence of all signs and symptoms of vulvovaginal candidiasis [ Time Frame: 28 days (+ 2 days) ]

Central Contacts

• Clinical Trial Manager
  513-709-4442
  [email protected]

Locations (27)

Find similar trials in Mobile, AL

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