Status:
COMPLETED
A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
Lead Sponsor:
Viamet
Conditions:
Recurrent Vulvovaginal Candidiasis
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
February 10 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2016
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT02267382
Start Date
February 10 2015
End Date
November 9 2016
Last Update
October 15 2019
Active Locations (32)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35233
2
Precision Trials
Phoenix, Arizona, United States, 85032
3
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72401
4
Axis Clinical Trials
Los Angeles, California, United States, 90017