At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 229 enrolled
Drug / intervention
arasertaconazole nitrate +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.
Multi-center, Randomized, Placebo-controlled, Parallel-group, Double-blinded Study to Compare the Therapeutic Efficacy, Safety, and Tolerability of 3 Single Vaginal Doses of Arasertaconazole Nitrate Pessaries in the Treatment of VVC
In Brief
A Phase 2 clinical trial evaluating arasertaconazole nitrate and placebo for Vulvovaginal Candidiasis. Completed, enrolled 229 participants across 1 site.
Detailed Summary
In order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will be conducted to compare the therapeutic efficacy, safety and tolerability of three different doses of arasertaconazole nitrate (150 mg, 300 mg or 600 mg, pessaries).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvovaginal Candidiasis
CountriesSpain
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2010
First PostedJun 2010
Primary CompletionMar 2011
TodayJul 2026
First PostedJun 15, 2010
Enrollment StartJun 1, 2010
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 16.0 years ago
Interventions
arasertaconazole nitratedrug
Arasertaconazole nitrate pessary, placebo pessary
placebodrug
placebo, single dose