At a glance
ClinicalIndex Comparison RecordN/ACompleted· 611 enrolled
Drug / intervention
Butoconazole Nitrate Vaginal Cream +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Butoconazole Nitrate Vaginal Cream, Placebo, and 1 other intervention for Vulvovaginal Candidiasis. Completed, enrolled 611 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvovaginal Candidiasis
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
Primary CompletionSep 2009
Study CompletionDec 2009
First PostedDec 2009
TodayJul 2026
First PostedDec 25, 2009
Enrollment StartFeb 1, 2008
Primary CompletionSep 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.5 years ago
Interventions
Butoconazole Nitrate Vaginal Creamdrug
vaginal cream
Placebodrug
vaginal cream
Gynazole 1 vaginal creamdrug
vaginal cream