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

NCT07109869 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-04-02

No results posted yet for this 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.

Conditions

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

Interventions

DRUG

Boric acid

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.

OTHER

Placebo

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

Sponsors & Collaborators

  • pH-D Feminine Health LLC

    lead INDUSTRY

Principal Investigators

  • Clinical Trial Manager · Medpace GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-08
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07109869 on ClinicalTrials.gov