Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection)
Lead Sponsor:
Viamet
Conditions:
Candidiasis, Vulvovaginal
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if the novel oral agent VT-1161 is safe and effective in treating patients with acute vulvovaginal candidiasis (also referred to as yeast infection). VT-1161 ...
Eligibility Criteria
Inclusion
- Key
- Females ≥18 and \<65 years
- Clinical diagnosis of symptomatic acute VVC
- Positive KOH .At least one vulvovaginal sign (vulvovaginal erythema, edema, or excoriation).
- At least one vulvovaginal symptom (vulvovaginal itching, burning, or irritation)
- A minimum composite vulvovaginal signs and symptoms score of ≥6
- must be be able to swallow capsules
Exclusion
- Evidence of major organ system disease
- History of cervical cancer
- History of diabetes mellitus
- Pregnant
- Recent use of systemic antifungal drugs or systemic antimicrobial therapy for any reason
- Recent use of drugs to treat vaginal infections
- Recent use of immunosuppressive therapies
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01891331
Start Date
August 1 2013
End Date
December 1 2014
Last Update
August 1 2018
Active Locations (8)
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1
Altus Research
Lake Worth, Florida, United States, 33461
2
Healthcare Clinical Data, Inc
North Miami, Florida, United States, 33161
3
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
4
Lyndhurst Clinical Research
Raleigh, North Carolina, United States, 27607