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

Recurrent Vulvovaginal Candidiasis Clinical Trial

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 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03562156
Study type Interventional
Source Mycovia Pharmaceuticals Inc.
Contact
Status Completed
Phase Phase 3
Start date August 16, 2018
Completion date August 6, 2021
View Details
See also
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Active, not recruiting NCT04734405 - A Phase IIb/III Study of Prof-001 for the Treatment of Patients With Recurrent Vulvovaginal Candidiasis (RVVC) Phase 2/Phase 3
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Not yet recruiting NCT04639544 - Effect of a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis N/A
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Completed NCT03561701 - A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) Phase 3
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Completed NCT03059992 - Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment Phase 3