At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 81 enrolled
Drug / intervention
Lidocaine +1 moredrug
Likely dose
Lidocaine 150mgfrom 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 Phase II, Double-Blind, Crossover Study to Assess the Efficacy and Safety of 10% (150mg) Lidocaine Vaginal Gel Administered to Women With Recurrent Dysmenorrhea
In Brief
A Phase 2 clinical trial evaluating Lidocaine and Placebo for Dysmenorrhea. Completed, enrolled 81 participants across 4 sites.
Detailed Summary
The purpose of this study is to determine whether lidocaine vaginal gel is safe and effective for preventing or reducing the severity of dysmenorrhea (painful menstrual periods) compared to placebo (inactive gel).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDysmenorrhea
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedApr 2008
Primary CompletionJun 2008
Study CompletionAug 2008
TodayJul 2026
First PostedApr 2, 2008
Enrollment StartAug 1, 2007
Primary CompletionJun 1, 2008
Study CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 18.3 years ago
Interventions
Lidocainedrug
Lidocaine vaginal gel 10% (150mg) administered once daily for 4 days
Placebodrug
Placebo vaginal gel administered once daily for 4 days