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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02267382
Other study ID # VMT-VT-1161-CL-006
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 10, 2015
Est. completion date November 9, 2016

Study information

Verified date October 2019
Source Viamet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 non-albicans Candida species that cause vulvovaginal candidiasis. VT-1161 is highly selective for fungal CYP51, and data suggests that it may avoid the side-effect profile that limits the use of commonly prescribed antifungal agents for the treatment of recurrent yeast infections.


Recruitment information / eligibility

Status Completed
Enrollment 254
Est. completion date November 9, 2016
Est. primary completion date November 9, 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Key Inclusion Criteria:

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 Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
VT-1161

Placebo


Locations

Country Name City State
United States Radiant Research Akron Ohio
United States University of Alabama Birmingham Birmingham Alabama
United States Clinical Trials Management LLC Covington Louisiana
United States New England Center for Clinical Research Fall River Massachusetts
United States Brownstone Clinical Trials Fort Worth Texas
United States TMC Life Research Houston Texas
United States Brownstone Clinical Trials Irving Texas
United States NEA Baptist Clinic Jonesboro Arkansas
United States Altus Research Lake Worth Florida
United States Clinical Research of Nevada Las Vegas Nevada
United States R. Garn Mabey, Jr. M.D. Chartered Las Vegas Nevada
United States OB/GYN Clinical Research Lawrenceville New Jersey
United States Axis Clinical Trials Los Angeles California
United States Axis Clinical Trials Los Angeles California
United States Clinical Trials Management LLC Metairie Louisiana
United States Healthcare Clinical Data Miami Florida
United States Community Medical Research North Miami Florida
United States Vision Clinical Research Palm Beach Florida
United States Drexel University College of Medicine Philadelphia Pennsylvania
United States Precision Trials Phoenix Arizona
United States Magee Women's Hospital Pittsburgh Pennsylvania
United States Women's Health Research Center Plainsboro New Jersey
United States Suffolk OB-GYN Port Jefferson New York
United States United Women's Clinical Research-Raleigh Raleigh North Carolina
United States Clinical Trials of Texas San Antonio Texas
United States Genesis Center for Clinical Research San Diego California
United States Physician's Research Options LLC Sandy Utah
United States Physician Care Clinical Research LLC Sarasota Florida
United States Seattle Women's Health Research Gynecology Seattle Washington
United States Clinical Research of West Florida Tampa Florida
United States Cypress Medical Research Center Wichita Kansas
United States Lyndhurst Clinical Research Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Viamet

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population. A culture-verified acute VVC episode was defined as a positive fungal culture for Candida species associated with a clinical signs and symptoms score of =3. To calculate the 'signs and symptoms' score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with higher scores indicating a worse outcome.
0 = none (complete absence of any sign or symptom)
= mild (slight)
= moderate (definitely present)
= severe (marked, intense)
48 Weeks
See also
  Status Clinical Trial Phase
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Completed NCT04029116 - Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC) Phase 3
Active, not recruiting NCT04734405 - A Phase IIb/III Study of Prof-001 for the Treatment of Patients With Recurrent Vulvovaginal Candidiasis (RVVC) Phase 2/Phase 3
Completed NCT01067131 - Safety and Immunogenicity Study of a Virosomal Vaccine Against Recurrent Vulvovaginal Candida Infection Phase 1
Completed NCT03840616 - Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections Phase 3
Recruiting NCT04699240 - Study of Lactobacillus in Adjuvant Treatment of RVVC Phase 4
Not yet recruiting NCT04639544 - Effect of a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis N/A
Recruiting NCT06190509 - Assessing the Safety, Immune Response, and Early Efficacy of a Candida Vaccine in Women With Recurrent Vulvovaginal Candidiasis: A Randomized Controlled Study Phase 1/Phase 2
Completed NCT03561701 - A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) Phase 3
Completed NCT03562156 - A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) Phase 3
Completed NCT05795491 - Blue Light Emitting Diode Therapy on Vulvovaginal Candidiasis N/A
Completed NCT03059992 - Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment Phase 3