NCT02888197

Non-Interventional Extension to Investigate Recurrence of Vulvovaginal Candidiasis and Candida Colonization

A Non-Interventional Extension Study to Investigate Vulvovaginal Candidiasis Recurrence and Candida Colonization Following a Phase 2 Randomized, Active-Controlled Study of Two Formulations of CD101 Compared to Fluconazole for the Treatment of Moderate to Severe Episodes of Acute Vulvovaginal Candidiasis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Non-interventional extension study to investigate VVC recurrence and candida colonization following the P2 acute VVC study

Detailed description

Following completion of the Phase 2, multicenter, randomized, active-controlled study of the safety and tolerability of two formulations of CD101 compared to fluconazole for the treatment of moderate to severe episodes of acute vulvovaginal candidiasis (NCT07299432), subjects without a recurrence of VVC will be followed up to an additional 90 days +/- 14 days to assess candida colonization and recurrence of VVC.

Conditions

• Candidiasis, Vulvovaginal
• Yeast Infection
• Mycoses
• Moniliasis, Vulvovaginal
• Vaginitis, Monilial

Timeline

• Start date: 2016-08-16
• Primary completion: 2017-03-15
• Completion: 2017-03-15
• First posted: 2016-09-02
• Last updated: 2018-03-02

Locations

23 sites across 1 country: United States