Clinical trial NCT03840616: Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections
Official title: Phase 3, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oteseconazole (VT-1161) Oral Capsules vs Fluconazole and Placebo in Treatment of Acute Vulvovaginal Candidiasis in Subjects With Recurrent Vulvovaginal Candidiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Recurrent Vulvovaginal Candidiasis
Lead sponsor: Mycovia Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-15
Enrollment: 219
Sex: FEMALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute vulvovaginal candidiasis (VVC) in the past 12 months. Several properties of oteseconazole (VT-1161) suggest it might be a safer and more effective treatment of RVVC than other oral antifungal medications.

This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the treatment of acute VVC episodes in patients with RVVC and consists of 2 parts. The first part of the study is a 2-week induction phase for the treatment of the patient's current VVC episode when the patient will take either fluconazole or oteseconazole (VT-1161) according to a random assignment. The second part consists of an 11-week maintenance phase, when the patient will take either oteseconazole (VT-1161) or a placebo according to the random assignment from the first part of the study, and then a 37-week follow-up period.


Eligibility criteria: Inclusion Criteria:

* 3 or more episodes of acute VVC in the past 12 months
* Positive KOH test
* Total vulvovaginal signs and symptoms score of ≥3 at screening visit
* Total vulvovaginal signs and symptoms score of \<3 at Day 14
* Must be able to swallow pills

Exclusion Criteria:

* Presence or a history of another vaginal or vulvar condition(s)
* Evidence of major organ system disease
* History of cervical cancer
* Poorly controlled diabetes mellitus
* Pregnant
* Recent use of topical or systemic antifungal or antibacterial drugs
* Recent use of immunosuppressive or systemic corticosteroid therapies

Primary outcomes:
measure: Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population
timeFrame: 48 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: 34
state: Arizona
city: Encino
country: United States
facility: 39
state: California
city: Los Angeles
country: United States
facility: 25
state: California
city: Englewood
country: United States
facility: 22
state: Colorado
city: Boca Raton
country: United States
facility: 49
state: Florida
city: Gainesville
country: United States
facility: 14
state: Florida
city: Leesburg
country: United States
facility: 13
state: Florida
city: Loxahatchee Groves
country: United States
facility: 33
state: Florida
city: Miami
country: United States
facility: 36
state: Florida
city: Savannah
country: United States
facility: 17
state: Georgia
city: Idaho Falls
country: United States
facility: 27
state: Idaho
city: Nampa
country: United States
facility: 10
state: Idaho
city: Chicago
country: United States
facility: 62
state: Illinois
city: Fort Wayne
country: United States
facility: 41
state: Indiana
city: Marrero
country: United States
facility: 30
state: Louisiana
city: Dearborn Heights
country: United States
facility: 50
state: Michigan
city: Saginaw
country: United States
facility: 29
state: Michigan
city: Traverse City
country: United States
facility: 55
state: Michigan
city: Troy
country: United States
facility: 32
state: Michigan
city: Kansas City
country: United States
facility: 26
state: Missouri
city: New Brunswick
country: United States
facility: 42
state: New Jersey
city: Ocean City
country: United States
facility: 47
state: New Jersey
city: Charlotte
country: United States
facility: 37
state: North Carolina
city: Fayetteville
country: United States
facility: 38
state: North Carolina
city: Columbus
country: United States
facility: 15
state: Ohio
city: Bluffton
country: United States
facility: 18
state: South Carolina
city: Myrtle Beach
country: United States
facility: 48
state: South Carolina
city: Bristol
country: United States
facility: 20
state: Tennessee
city: Murfreesboro
country: United States
facility: 21
state: Tennessee
city: Austin
country: United States
facility: 24
state: Texas
city: Fort Worth
country: United States
facility: 23
state: Texas
city: Katy
country: United States
facility: 63
state: Texas
city: League City
country: United States
facility: 58
state: Texas
Study officials:
References: