At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 140 enrolled
Drug / intervention
Terconazole Vaginal Suppository +1 moredrug
Likely dose
Fluconazole 150 mgfrom 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, Parallel-group Study of Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe
In Brief
A Phase 4 clinical trial evaluating Terconazole Vaginal Suppository and Fluconazole for Vulvovaginal Candidiasis. Completed, enrolled 140 participants across 1 site.
Detailed Summary
The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with severe vulvovaginal candidiasis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvovaginal Candidiasis
CountriesChina
CollaboratorsShanghai Shyndec Pharmaceutical Co., Ltd.
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartAug 2013
Primary CompletionJun 2014
First PostedJul 2014
TodayJul 2026
First PostedJul 2, 2014
Enrollment StartAug 1, 2013
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12 years ago
Interventions
Terconazole Vaginal Suppositorydrug
Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
Fluconazoledrug
orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.