NCT03562156

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 438 (actual)
• Sponsor: Mycovia Pharmaceuticals Inc. · Industry
• Sex: Female
• Age: 12 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Recurrent Vulvovaginal Candidiasis

Interventions

Type	Name	Description
DRUG	Oteseconazole (VT-1161)	Oteseconazole (VT-1161) 150mg capsule
DRUG	Placebo	matching placebo capsule

Timeline

• Start date: 2018-08-16
• Primary completion: 2020-10-19
• Completion: 2021-08-06
• First posted: 2018-06-19
• Last updated: 2026-02-17
• Results posted: 2022-01-13

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study