NCT01039584

A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations

A Randomized Study Evaluating the Therapeutic Equivalence and Safety of Butoconazole Nitrate Vaginal Cream, 2% and Gynazole 1 (Butoconazole Nitrate) Vaginal Cream, 2%, Against a Vehicle Control in the Treatment of Vulvovaginal Candidiasis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 611 (actual)
• Sponsor: Padagis LLC · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This was a study that compared the efficacy and safety of a generic butoconazole nitrate vaginal cream, 2% to Gynazole-1 (butoconazole nitrate) Vaginal Cream, 2% in the treatment of vulvovaginal candidiasis caused by Candida species.

Conditions

• Vulvovaginal Candidiasis

Interventions

Type	Name	Description
DRUG	Butoconazole Nitrate Vaginal Cream	vaginal cream
DRUG	Placebo	vaginal cream
DRUG	Gynazole 1 vaginal cream	vaginal cream

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-09-01
• Completion: 2009-12-01
• First posted: 2009-12-25
• Last updated: 2023-07-12
• Results posted: 2013-01-21

Locations

1 site across 1 country: United States