Overview

This trial is active, not recruiting.

Condition recurrent vulvovaginal candidiasis
Treatments vt-1161, placebo
Phase phase 2
Sponsor Viamet
Start date February 2015
End date July 2016
Trial size 200 participants
Trial identifier NCT02267382, VMT-VT-1161-CL-006

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Low dose 12-week: Loading doses of 150 mg once daily for 7 days, then 150 mg once weekly for 11 weeks, followed by placebo once weekly for 12 weeks.
vt-1161
(Experimental)
Low dose 24-week: Loading doses of 150 mg once daily for 7 days, then 150 mg once weekly for 23 weeks
vt-1161
(Experimental)
High dose 12-week: Loading doses of 300 mg once daily for 7 days, then 300 mg once weekly for 11 weeks, followed by placebo once weekly for 12 weeks
vt-1161
(Experimental)
High dose 24-week: Loading doses of 300 mg once daily for 7 days, then 300 mg once weekly for 23 weeks
vt-1161
(Placebo Comparator)
Placebo 24-Weeks.
placebo

Primary Outcomes

Measure
To evaluate the safety and efficacy of 4 dosing regimens of oral VT-1161 for the prevention of culture-verified acute vulvovaginal candidiasis (VVC) episodes through Week 48
time frame: 48 Weeks

Eligibility Criteria

Female participants from 18 years up to 65 years old.

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 corticosteriod therapies

Additional Information

Official title A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients With Recurrent Vulvovaginal Candidiasis
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Viamet.