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Medicine and Health Sciences Commons

Open Access. Powered by Scholars. Published by Universities.®

Obstetrics and Gynecology

Thomas Jefferson University

2021

Antifungal Agents

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Full-Text Articles in Medicine and Health Sciences

A Randomized Phase 2 Study Of Vt-1161 For The Treatment Of Acute Vulvovaginal Candidiasis, Stephen R Brand, Jack D Sobel, Paul Nyirjesy, Mahmoud A Ghannoum, Robert J Schotzinger, Thorsten P Degenhardt Oct 2021

A Randomized Phase 2 Study Of Vt-1161 For The Treatment Of Acute Vulvovaginal Candidiasis, Stephen R Brand, Jack D Sobel, Paul Nyirjesy, Mahmoud A Ghannoum, Robert J Schotzinger, Thorsten P Degenhardt

Department of Obstetrics and Gynecology Faculty Papers

Background: Acute vulvovaginal candidiasis (VVC) is common among women, but current azole antifungal treatments are often associated with safety and resistance issues. VT-1161 (oteseconazole) is an oral agent with increased selectivity for fungal CYP51. In this phase 2 clinical study, we evaluated the efficacy and safety of VT-1161 vs fluconazole in participants with moderate to severe acute VVC.

Methods: Participants presenting with an acute episode of VVC (n = 55) were randomized to receive VT-1161 300 mg once daily (q.d.) for 3 days, 600 mg q.d. for 3 days, or 600 mg twice daily (b.i.d.) for 3 days or to …