A Study of Oral Oteseconazole (VT-1161) 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: NCT03561701
• Other study ID #: VMT-VT-1161-CL-012
• Status: Completed
• Phase: Phase 3
• Start date: August 23, 2018
• Est. completion date: August 3, 2021

Study information

• Verified date: December 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: August 3, 2021
• Est. primary completion date: October 13, 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 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

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	31229	Columbus	Ohio
United States	31244	Columbus	Ohio
United States	31222	Englewood	Ohio
United States	31232	Frisco	Texas
United States	31245	Hagerstown	Maryland
United States	31240	Hartford	Connecticut
United States	31204	Homestead	Florida
United States	31218	Jackson	Tennessee
United States	31227	Little Rock	Arkansas
United States	31217	Los Angeles	California
United States	31233	North Bay Village	Florida
United States	31215	Phoenix	Arizona
United States	31255	Wichita	Kansas
United States	31223	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 (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. 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)