Status:
COMPLETED
Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections
Lead Sponsor:
Mycovia Pharmaceuticals Inc.
Conditions:
Recurrent Vulvovaginal Candidiasis
Eligibility:
FEMALE
12+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2020
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT03840616
Start Date
March 13 2019
End Date
December 2 2020
Last Update
February 4 2022
Active Locations (33)
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1
34
Tucson, Arizona, United States, 85712
2
39
Encino, California, United States, 91436
3
25
Los Angeles, California, United States, 90036
4
22
Englewood, Colorado, United States, 80112