Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections

Recurrent Vulvovaginal Candidiasis Clinical Trial

— ultraVIOLET  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03840616
• Other study ID #: VMT-VT-1161-CL-017
• Status: Completed
• Phase: Phase 3
• Start date: March 13, 2019
• Est. completion date: December 2, 2020

Study information

• Verified date: November 2021
• Source: Mycovia Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: December 2, 2020
• Est. primary completion date: December 2, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Recurrent Vulvovaginal Candidiasis

Intervention

Drug:
• Oteseconazole (VT-1161) 150mg capsule
600mg 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
150mg administered every 72 hours in 3 sequential doses starting on Day 1.
• Placebo
Administered once weekly starting on Day 14.

Locations

Country	Name	City	State
United States	24	Austin	Texas
United States	18	Bluffton	South Carolina
United States	49	Boca Raton	Florida
United States	20	Bristol	Tennessee
United States	37	Charlotte	North Carolina
United States	62	Chicago	Illinois
United States	15	Columbus	Ohio
United States	50	Dearborn Heights	Michigan
United States	39	Encino	California
United States	22	Englewood	Colorado
United States	38	Fayetteville	North Carolina
United States	41	Fort Wayne	Indiana
United States	23	Fort Worth	Texas
United States	14	Gainesville	Florida
United States	27	Idaho Falls	Idaho
United States	26	Kansas City	Missouri
United States	63	Katy	Texas
United States	58	League City	Texas
United States	13	Leesburg	Florida
United States	25	Los Angeles	California
United States	33	Loxahatchee Groves	Florida
United States	30	Marrero	Louisiana
United States	36	Miami	Florida
United States	21	Murfreesboro	Tennessee
United States	48	Myrtle Beach	South Carolina
United States	10	Nampa	Idaho
United States	42	New Brunswick	New Jersey
United States	47	Ocean City	New Jersey
United States	29	Saginaw	Michigan
United States	17	Savannah	Georgia
United States	55	Traverse City	Michigan
United States	32	Troy	Michigan
United States	34	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mycovia Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	48 Weeks