At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 105 enrolled
Drug / intervention
Lidocaine/Diphenhydramine +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.
Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort
In Brief
A Phase 2 clinical trial evaluating Lidocaine/Diphenhydramine, lidocaine, and 1 other intervention for Vulvodynia. Completed, enrolled 105 participants across 48 sites in 2 countries.
Detailed Summary
This study will evaluate the efficacy and safety of two vaginal products compared with that of placebo to determine if the two products are better than placebo in the relief of vaginal discomfort.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvodynia
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2007
First PostedJan 2008
Primary CompletionJun 2009
Study CompletionJul 2009
TodayJul 2026
First PostedJan 10, 2008
Enrollment StartOct 1, 2007
Primary CompletionJun 1, 2009
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.5 years ago
Interventions
Lidocaine/Diphenhydraminedrug
semi solid, twice weekly, 4 months
lidocainedrug
semi solid, twice weekly for 4 months
placebodrug
semi solid, twice weekly for 4 months