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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


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

See also
  Status Clinical Trial Phase
Recruiting NCT05074602 - A Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Recurrent Vulvovaginal Candidiasis Phase 3
Completed NCT04029116 - Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC) Phase 3
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
Completed NCT01067131 - Safety and Immunogenicity Study of a Virosomal Vaccine Against Recurrent Vulvovaginal Candida Infection Phase 1
Completed NCT03840616 - Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections Phase 3
Recruiting NCT04699240 - Study of Lactobacillus in Adjuvant Treatment of RVVC Phase 4
Not yet recruiting NCT04639544 - Effect of a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis N/A
Completed NCT02267382 - A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) Phase 2
Recruiting NCT06190509 - Assessing the Safety, Immune Response, and Early Efficacy of a Candida Vaccine in Women With Recurrent Vulvovaginal Candidiasis: A Randomized Controlled Study Phase 1/Phase 2
Completed NCT03561701 - A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) Phase 3
Completed NCT05795491 - Blue Light Emitting Diode Therapy on Vulvovaginal Candidiasis N/A
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