A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)

Recurrent Vulvovaginal Candidiasis Clinical Trial

— VIOLET  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03562156
• Other study ID #: VMT-VT-1161-CL-011
• Status: Completed
• Phase: Phase 3
• Start date: August 16, 2018
• Est. completion date: August 6, 2021

Study information

• Verified date: April 2022
• 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: August 6, 2021
• Est. primary completion date: October 19, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Recurrent Vulvovaginal Candidiasis

Intervention

Drug:
• Oteseconazole (VT-1161)
Oteseconazole (VT-1161) 150mg capsule
• Placebo
matching placebo capsule

Locations

Country	Name	City	State
United States	31123	Birmingham	Alabama
United States	31120	Bristol	Tennessee
United States	31146	Covington	Louisiana
United States	31117	Draper	Utah
United States	31147	Fall River	Massachusetts
United States	31125	Franklin	Ohio
United States	31132	Greensboro	North Carolina
United States	31102	Houston	Texas
United States	31103	Las Vegas	Nevada
United States	31118	Las Vegas	Nevada
United States	31139	Lauderdale Lakes	Florida
United States	31114	Lawrenceville	New Jersey
United States	31105	Metairie	Louisiana
United States	31107	Metairie	Louisiana
United States	31116	Morehead City	North Carolina
United States	31111	Norcross	Georgia
United States	31134	Philadelphia	Pennsylvania
United States	31142	Port Jefferson	New York
United States	31144	Raleigh	North Carolina
United States	31113	Richmond	Virginia
United States	31108	San Diego	California
United States	31143	Sarasota	Florida
United States	31106	Wellington	Florida
United States	31127	West Seneca	New York
United States	31145	Winston-Salem	North Carolina

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 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. 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)	Maintenance phase (post-randomization through Week 48)