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

Purpose

CYP51 is an enzyme essential for fungal growth. Inhibition of CYP51 results in the accumulation of compounds toxic to the fungus. CYP51 is the target of the class of drugs referred to as 'azole antifungals'. The lack of selectivity by the azole antifungals is responsible for many of the side effects associated with these drugs. VT-1161 has been design to be safer and more active against the fungal species typically responsible for vaginal yeast infections (i.e. vulvovaginal candidiasis)

Condition	Intervention	Phase
Candidiasis, Vulvovaginal	Drug: VT-1161 (oral) Drug: Fluconazole (oral)	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase 2a, Randomized, Double-Blind, Dose Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets Compared to Fluconazole in the Treatment of Patients With Moderate to Severe Acute Vulvovaginal Candidiasis

Resource links provided by NLM:

MedlinePlus related topics: Yeast Infections

Drug Information available for: Fluconazole

U.S. FDA Resources

Further study details as provided by Viamet:

Primary Outcome Measures:

To evaluate the composite clinical efficacy of oral VT-1161 compared with fluconazole in the treatment of patients with moderate to severe acute vulvovaginal candidiasis [ Time Frame: Test of Cure conducted at baseline (day 1) ] [ Designated as safety issue: No ]
Vulvovaginal signs and symptoms will be evaluated at screening/baseline and at test of cure day 28 (Week 4)
To evaluate the composite clinical efficacy of oral VT-1161 compared with oral fluconazole in the treatment of patients with moderate to severe acute vulvovaginal candidiasis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Clinical efficacy will be evaluated at screening/baseline (Day 1) and at test-of-cure visit Week 4 (Day 28)


Enrollment:	55
Study Start Date:	August 2013
Study Completion Date:	December 2014
Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: VT-1161 (oral) VT-1161 300 mg q.d. for 3 days	Drug: VT-1161 (oral)
Active Comparator: Fluconazole Fluconazole 150 mg administered orally in a single dose (administered blinded to match the VT-1161 dose regimens)	Drug: Fluconazole (oral)

Eligibility


Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01891331

Locations


United States, Florida
Altus Research
Lake Worth, Florida, United States, 33461
Healthcare Clinical Data, Inc
North Miami, Florida, United States, 33161
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
United States, North Carolina
Lyndhurst Clinical Research
Raleigh, North Carolina, United States, 27607
Lyndhurst Clinical Research
Winston Salem, North Carolina, United States, 27103
United States, Pennsylvania
Drexel Vaginitis Center
Philadelphia, Pennsylvania, United States, 19102
United States, Texas
Brownstone Clinical Trials, LLC
Irving, Texas, United States, 75062
United States, Washington
Harborview ID Research Clinic
Seattle, Washington, United States, 98104

Sponsors and Collaborators

Viamet

More Information

No publications provided


Responsible Party:	Viamet
ClinicalTrials.gov Identifier:	NCT01891331 History of Changes
Other Study ID Numbers:	VMT-VT-1161-CL-004
Study First Received:	June 17, 2013
Last Updated:	December 22, 2014
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Candidiasis Candidiasis, Vulvovaginal Genital Diseases, Female Mycoses Vaginal Diseases Vaginitis Vulvar Diseases Vulvitis Vulvovaginitis	Fluconazole 14-alpha Demethylase Inhibitors Anti-Infective Agents Antifungal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015