A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) (VIOLET)

Mycovia Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Recurrent Vulvovaginal Candidiasis

Treatments: Drug: Placebo; Drug: Oteseconazole (VT-1161)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03561701

VMT-VT-1161-CL-012

Details and patient eligibility

About

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.

Enrollment: 425 patients

Sex: Female

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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425 participants in 2 patient groups, including a placebo group

Oteseconazole (VT-1161) 150mg capsule

Experimental group

Description:

Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks

Treatment:

Drug: Oteseconazole (VT-1161)

Placebo capsule

Placebo Comparator group

Description:

Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks

Treatment:

Drug: Placebo