Conditions: Hot Flashes
Keywords: Hot Flushes Vasomotor Symptoms Menopausal Hot Flashes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 600
Healthy volunteers: no

Brief 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

Detailed description:
The primary study objective is to assess the efficacy of G-ER dosed at 1800mg daily (600mg AM, 1200mg PM), compared to placebo in reducing the average daily frequency and severity score of moderate to severe hot flashes in postmenopausal women at weeks 4 \& 12 of the efficacy treatment period, compared with baseline.

Arms:
arm 1: Active treatment arm 2: Placebo

Interventions: intervention 1: Gabapentin Extended Release intervention 2: Placebo
Intervention descriptions: intervention 1: Gabapentin ER 1800mg daily intervention 2: Sugar pill

Protocol document: