Clinical trial NCT03562156: A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oteseconazole (VT-1161) Oral Capsules in the Treatment of 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: 2018-06-19
Enrollment: 438
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 VVC in the past 12 months. Several properties of oteseconazole (VT-1161) suggest that it might be a safer and more effective treatment for RVVC than other oral anti-fungal medicines.

This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the treatment of RVVC and consists of 2 parts. The first part of the study is a 2-week period for the treatment of the patient's current VVC episode with 3 150mg doses of fluconazole. The 2nd part consists of 12 weeks, when the patient will take either oteseconazole (VT-1161) 150 mg or a placebo (according to a random assignment), and then a 36-week follow-up period.

In addition, at participating sites, an amendment to the study allows US patients who complete the initial 48 weeks without experiencing a confirmed RVVC episode to continue in a 48-week observational extension period designed to evaluate the continued effectiveness of oteseconazole (VT-1161).

This study is identical to VMT-VT-1161-CL-012 (NCT03561701).


Eligibility criteria: Key Inclusion Criteria:

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

Key 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 Population
timeFrame: Maintenance phase (post-randomization through Week 48)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 31123
state: Alabama
city: San Diego
country: United States
facility: 31108
state: California
city: Lauderdale Lakes
country: United States
facility: 31139
state: Florida
city: Sarasota
country: United States
facility: 31143
state: Florida
city: Wellington
country: United States
facility: 31106
state: Florida
city: Norcross
country: United States
facility: 31111
state: Georgia
city: Covington
country: United States
facility: 31146
state: Louisiana
city: Metairie
country: United States
facility: 31107
state: Louisiana
city: Metairie
country: United States
facility: 31105
state: Louisiana
city: Fall River
country: United States
facility: 31147
state: Massachusetts
city: Las Vegas
country: United States
facility: 31118
state: Nevada
city: Las Vegas
country: United States
facility: 31103
state: Nevada
city: Lawrenceville
country: United States
facility: 31114
state: New Jersey
city: Port Jefferson
country: United States
facility: 31142
state: New York
city: West Seneca
country: United States
facility: 31127
state: New York
city: Greensboro
country: United States
facility: 31132
state: North Carolina
city: Morehead City
country: United States
facility: 31116
state: North Carolina
city: Raleigh
country: United States
facility: 31144
state: North Carolina
city: Winston-Salem
country: United States
facility: 31145
state: North Carolina
city: Franklin
country: United States
facility: 31125
state: Ohio
city: Philadelphia
country: United States
facility: 31134
state: Pennsylvania
city: Bristol
country: United States
facility: 31120
state: Tennessee
city: Houston
country: United States
facility: 31102
state: Texas
city: Draper
country: United States
facility: 31117
state: Utah
city: Richmond
country: United States
facility: 31113
state: Virginia
Study officials:
References: