VMT-VT-1161-CL-011 - Recurrent Vulvovaginal Candidiasis
Research type
Research Study
Full title
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
IRAS ID
252990
Contact name
Jonathan Ross
Contact email
Sponsor organisation
Mycovia Pharmaceuticals
Eudract number
2018-001269-18
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
2 years, 1 months, 0 days
Research summary
This is 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.
Around 300 subjects at approximately 80 study centres in North America, Europe, and Japan will take part in this study. There will be 3 centres in the UK.
This study is for nonpregnant females aged 12 years or older that have been diagnosed with recurrent yeast infections. This is a Phase 3 study, which means that the study drug has been investigated in previous studies involving smaller groups of people with recurrent vulvovaginal candidiasis, sometimes called “recurrent yeast infection.”
The purpose of this research study is to see how safe the study drug (VT-1161) is, how well it works, and how it effects the quality of life in people with recurrent yeast infections.The participant and study doctor will not know if the participant is receiving the study drug or placebo (this is called a “blinded study”).
Participation in this research study will last for approximately 50 weeks.
The Sponsor of this study is Mycovia Pharmaceuticals.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
18/EM/0384
Date of REC Opinion
8 Jan 2019
REC opinion
Further Information Favourable Opinion