Phase 2 N=215 Randomized Double-blind Treatment

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

Recurrent Vulvovaginal Candidiasis

Bottom Line

View on ClinicalTrials.gov: NCT02267382 ↗

Enrolled (actual)

215

Serious AEs

2.4%

Results posted

Oct 2019

Primary outcome: Primary: The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population. — 2; 3; 0; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: VT-1161 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Viamet
Primary completion: Nov 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population.	2; 3; 0; 2; 24	—

Summary

VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in vivo pharmacology studies have demonstrated that VT-1161 is highly active against Candida albicans and also non-albicans Candida species that cause vulvovaginal candidiasis. VT-1161 is highly selective for fungal CYP51, and data suggests that it may avoid the side-effect profile that limits the use of commonly prescribed antifungal agents for the treatment of recurrent yeast infections.

Eligibility Criteria

Key Inclusion Criteria

Clinical diagnosis of symptomatic acute VVC

3 or more episodes of acute VVC in the past 12 months

Positive KOH

Minimum composite vulvovaginal signs and symptoms score of ≥3 at Screening

Composite vulvovaginal signs and symptoms score of <3 at Baseline

Must be able to swallow tablets

Key Exclusion Criteria

Evidence of major organ system disease

Presence or a history of another vaginal or vulvar condition(s)

History of cervical cancer

Poorly controlled diabetes mellitus

Pregnant

Recent use of topical or systemic antifungal drugs

Recent use of immunosuppressive or system corticosteroid therapies

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02267382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.