TrialScout

A Study of Oral VT-1161 for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)

Female
Age
12+
Phase 3

Brief Summary

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VT-1161 Oral Capsules in the Treatment of Subjects With Recurrent Vulvovaginal Candidiasis



ClinicalTrials.gov Identifier: NCT03562156
Recruitment Status: Recruiting
First Posted: 6/19/2018 12:00:00 AM
Last Update Posted: 4/17/2019 12:00:00 AM

Keywords

Candidiasis
Candidiasis, Vulvovaginal

Intervention/Treatment

Drug: VT-1161 / VT-1161 150mg capsule

You may be eligible to join if...


key

- 3 or more episodes of acute vvc in the past 12 months

- positive koh or gram stain

- total vulvovaginal signs and symptoms score of ≥3 at screening visit

- total vulvovaginal signs and symptoms score of <3 at baseline visit

- must be able to swallow pills

key

You may NOT be eligible to join if...



- presence or a history of another vaginal or vulvar condition(s)

- evidence of major organ system disease

- history of cervical cancer

- poorly controlled diabetes mellitus

- pregnant

- recent use of topical or systemic antifungal or antibacterial drugs

- recent use of immunosuppressive or systemic corticosteroid therapies

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