At a glance
ClinicalIndex Comparison RecordN/ACompleted· 572 enrolled
Drug / intervention
Terconazole Vaginal Suppository +1 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 Multi-center, Randomized, Investigator-blinded, Parallel-group Study, Designed to Evaluate the Safety and Clinical Equivalence of Terconazole Vaginal Suppositories, 80 mg (Test Product) and Terconazole Vaginal Suppositories, 80 mg (Reference Product) in the Treatment of Vulvovaginal Candidiasis Caused by Candida Species
In Brief
A clinical study evaluating Terconazole Vaginal Suppository and Terazol Vaginal Suppository for Vulvovaginal Candidiasis. Completed, enrolled 572 participants.
Detailed Summary
The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg(Test Product) and Terconazole Vaginal Suppositories, 80 mg(Reference Product) in the treatment of subjects with vulvovaginal candidiasis in order to establish bioequivalence.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvovaginal Candidiasis
Countries--
Collaborators--
Timeline
N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2002
Primary CompletionDec 2003
First PostedDec 2008
TodayJul 2026
First PostedDec 8, 2008
Enrollment StartDec 1, 2002
Primary CompletionDec 1, 2003
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 17.6 years ago
Interventions
Terconazole Vaginal Suppositorydrug
Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days
Terazol Vaginal Suppositorydrug
Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days