NCT01080300

Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Depomed · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hot Flashes

Interventions

Type	Name	Description
DRUG	Gabapentin Extended Release	Gabapentin ER 1800mg daily
DRUG	Placebo	Sugar pill

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2010-03-04
• Last updated: 2020-05-01
• Results posted: 2014-03-26

Locations

66 sites across 1 country: United States