Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections
- Conditions
- Recurrent Vulvovaginal Candidiasis
- Interventions
- Registration Number
- NCT03840616
- Lead Sponsor
- Mycovia Pharmaceuticals Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 219
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oteseconazole (VT-1161) 150mg capsule Oteseconazole (VT-1161) 150mg capsule 600mg oteseconazole administered on Day 1 and 450mg administered on Day 2, followed by 150mg administered once weekly for 11 weeks staring on Day 14 Fluconazole 150mg capsule / Placebo Placebo 150mg fluconazole administered every 72 hours in 3 sequential doses starting on Day 1, followed by placebo administered once weekly starting on Day 14 Fluconazole 150mg capsule / Placebo Fluconazole 150mg capsule 150mg fluconazole administered every 72 hours in 3 sequential doses starting on Day 1, followed by placebo administered once weekly starting on Day 14
- Primary Outcome Measures
Name Time Method 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 48 Weeks The primary efficacy outcome measure was the percentage of subjects with 1 or more culture-verified acute VVC episodes during the maintenance phase (post-randomization through Week 48) in the intent-to-treat population, which includes subjects who failed to clear their initial acute VVC episode during the induction phase. An acute VVC episode during the maintenance phase (considered a recurrent episode) was defined as a positive fungal culture for Candida species and 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 a higher score indicating a worse outcome.
0 = none (complete absence of any sign or symptom), 1 = mild (slight), 2 = moderate (definitely present), 3 = severe (marked, intense)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (33)
27
🇺🇸Idaho Falls, Idaho, United States
36
🇺🇸Miami, Florida, United States
62
🇺🇸Chicago, Illinois, United States
15
🇺🇸Columbus, Ohio, United States
41
🇺🇸Fort Wayne, Indiana, United States
29
🇺🇸Saginaw, Michigan, United States
47
🇺🇸Ocean City, New Jersey, United States
20
🇺🇸Bristol, Tennessee, United States
63
🇺🇸Katy, Texas, United States
32
🇺🇸Troy, Michigan, United States
49
🇺🇸Boca Raton, Florida, United States
10
🇺🇸Nampa, Idaho, United States
25
🇺🇸Los Angeles, California, United States
14
🇺🇸Gainesville, Florida, United States
17
🇺🇸Savannah, Georgia, United States
23
🇺🇸Fort Worth, Texas, United States
26
🇺🇸Kansas City, Missouri, United States
38
🇺🇸Fayetteville, North Carolina, United States
18
🇺🇸Bluffton, South Carolina, United States
48
🇺🇸Myrtle Beach, South Carolina, United States
22
🇺🇸Englewood, Colorado, United States
21
🇺🇸Murfreesboro, Tennessee, United States
34
🇺🇸Tucson, Arizona, United States
13
🇺🇸Leesburg, Florida, United States
33
🇺🇸Loxahatchee Groves, Florida, United States
30
🇺🇸Marrero, Louisiana, United States
39
🇺🇸Encino, California, United States
55
🇺🇸Traverse City, Michigan, United States
50
🇺🇸Dearborn Heights, Michigan, United States
42
🇺🇸New Brunswick, New Jersey, United States
24
🇺🇸Austin, Texas, United States
58
🇺🇸League City, Texas, United States
37
🇺🇸Charlotte, North Carolina, United States