Biweekly Long-term Occidiofungin Study for Suppression of Mycotic Recurrence

Conditions

• Candidiasis, Vulvovaginal

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• OCF001 Intravaginal Gel — DRUG
  OCF001 is an antifungal antibiotic that is formulated in a water-miscible viscous gel at concentrations of 0.150 mg / g of gel.
• Placebo Gel — DRUG
  Placebo (Gel formulation without OCF)

Study Details

A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study Evaluating the Safety, Tolerability, and Efficacy of OCF001 Intravaginal Gel in Women with Acute Vulvovaginal Candidiasis

Key Dates

First listed

Apr 9, 2026

Start date

Jun 4, 2026

Status verified

Jun 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

36 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Occidiofungin
  Participants will receive 5 g of OCF001 vaginal gel once daily for 7 days.
• Placebo Comparator: Placebo
  Participants will receive 5 g of placebo vaginal gel once daily for 7 days

Primary Outcome Measure

To evaluate the clinical cure of OCF001 (drug product) to treat acute VVC infection following 7-day intravaginal dose of drug product [ Time Frame: 7 days ]

Central Contacts

• James Smith
  662-574-5957
  [email protected]

Locations (1)

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