Clinical trial NCT03561701: A Study of Oral Oteseconazole (VT-1161) 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: 425
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 antifungal 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-011.


Eligibility criteria: Key Inclusion Criteria:

* 3 or more episodes of acute VVC in the past 12 months
* Positive KOH or Gram stain test
* 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 (ITT) Population.
timeFrame: Maintenance phase (post-randomization through Week 48)
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: 31215
state: Arizona
city: Little Rock
country: United States
facility: 31227
state: Arkansas
city: Los Angeles
country: United States
facility: 31217
state: California
city: Hartford
country: United States
facility: 31240
state: Connecticut
city: Homestead
country: United States
facility: 31204
state: Florida
city: North Bay Village
country: United States
facility: 31233
state: Florida
city: Wichita
country: United States
facility: 31255
state: Kansas
city: Hagerstown
country: United States
facility: 31245
state: Maryland
city: Winston-Salem
country: United States
facility: 31223
state: North Carolina
city: Columbus
country: United States
facility: 31244
state: Ohio
city: Columbus
country: United States
facility: 31229
state: Ohio
city: Englewood
country: United States
facility: 31222
state: Ohio
city: Jackson
country: United States
facility: 31218
state: Tennessee
city: Frisco
country: United States
facility: 31232
state: Texas
Study officials:
References: