Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT02733432
Brief Summary:
The purpose of this study is to determine if two topical formulations of CD101 are safe and effective in the treatment of acute moderate to severe vulvovaginal candidiasis (VVC) compared to oral fluconazole.
Detailed Description:
This is a Phase 2, multicenter, randomized, open-label, sponsor-blind, active-controlled, dose-ranging trial of female subjects with an acute moderate to severe episode of vulvovaginal candidiasis. Subjects will be randomized to 1 of 3 treatment arms; CD101 gel, CD101 ointment, or oral fluconazole. After randomization, subjects will be seen on Day 7 (+/-2 days), Day 14 (+/- 2 days), \& Day 28 (+/-7 days) to assess therapeutic cure and safety.
Study:
NCT02733432
Study Brief:
Protocol Section:
NCT02733432