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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Viamet Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01891331
First received: June 17, 2013
Last updated: March 14, 2014
Last verified: March 2014
  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:


Further study details as provided by Viamet Pharmaceuticals, Inc.:

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)


Estimated Enrollment: 48
Study Start Date: August 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 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 Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Viamet Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01891331     History of Changes
Other Study ID Numbers: VMT-VT-1161-CL-004
Study First Received: June 17, 2013
Last Updated: March 14, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014