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

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ClinicalTrials.gov Identifier: NCT01891331
Recruitment Status : Completed
First Posted : July 3, 2013
Results First Posted : July 6, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Viamet

Tracking Information
First Submitted Date  ICMJE June 17, 2013
First Posted Date  ICMJE July 3, 2013
Results First Submitted Date  ICMJE June 6, 2018
Results First Posted Date  ICMJE July 6, 2018
Last Update Posted Date August 1, 2018
Study Start Date  ICMJE August 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2018)
Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population [ Time Frame: 4 weeks ]
For this trial, therapeutic cure was defined as mycological AND clinical cure. Mycological cure was defined as a negative fungal culture for Candida species. Clinical cure was defined as all of the following:
  1. complete resolution of signs and symptoms pertaining to vulvovaginal candidiasis;
  2. any new sign or symptom observed at 28 days determined by investigator to not be related to vulvovaginal candidiasis;
  3. no use of any other antifungal drug therapy for treatment of vulvovaginal irritation and/or pruritus by subject.
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
  • To evaluate the composite clinical efficacy of 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) ]
    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 VT-1161 compared with fluconazole in the treatment of patients with moderate to severe acute vulvovaginal candidiasis [ Time Frame: 4 weeks ]
    Clinical efficacy will be evaluated at screening/baseline (Day 1) and at test-of-cure visit Week 4 (Day 28)
Change History Complete list of historical versions of study NCT01891331 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection)
Official Title  ICMJE 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
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 has been designed to inhibit CYP51, an enzyme essential for fungal growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this results in many of the side effects associated with the azole antifungals. The safety profile of the class similarly limits use in chronic treatment of non-life-threatening fungal infections. 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Candidiasis, Vulvovaginal
Intervention  ICMJE
  • Drug: VT-1161
  • Drug: Fluconazole
Study Arms  ICMJE
  • Experimental: VT-1161 300mg QD
    Intervention: Drug: VT-1161
  • Experimental: VT-1161 600mg QD
    Intervention: Drug: VT-1161
  • Experimental: VT-1161 600mg BID
    Intervention: Drug: VT-1161
  • Active Comparator: Fluconazole 150mg
    Intervention: Drug: Fluconazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 22, 2014)
55
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2013)
48
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01891331
Other Study ID Numbers  ICMJE VMT-VT-1161-CL-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Viamet
Study Sponsor  ICMJE Viamet
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Viamet
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP