At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 600 enrolled
Drug / intervention
Gabapentin Extended Release +1 moredrug
Likely dose
Gabapentin Extended Release 1800mgfrom 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 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Gabapentin Extended Release (G-ER_ Tablets in the Treatment of Vasomotor Symptoms in Postmenopausal Women
In Brief
A Phase 3 clinical trial evaluating Gabapentin Extended Release and Placebo for Hot Flashes. Completed, enrolled 600 participants across 66 sites.
Detailed Summary
Depomed's Gabapentin Extended Release is an investigational, extended release formulation of Gabapentin that is being studied for the treatment of Hot Flashes/Hot Flushes in postmenopausal women
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHot Flashes
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2010
Enrollment StartAug 2010
Primary CompletionSep 2011
TodayJul 2026
First PostedMar 4, 2010
Enrollment StartAug 1, 2010
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.3 years ago
Interventions
Gabapentin Extended Releasedrug
Gabapentin ER 1800mg daily
Placebodrug
Sugar pill