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.

Trial Profile

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Oct 2013

At a glance

  • Drugs Gabapentin (Primary)
  • Indications Hot flashes; Menopausal syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms BREEZE-1
  • Sponsors DepoMed
  • Most Recent Events

    • 12 Oct 2013 Pooled analysis of the BREEZE-1, -2 and -3 trials presented at the 24th Annual Meeting of the North American Menopause Society.
    • 31 Jul 2012 Additional results from the BREEZE programme will be reported at the 2012 North American Menopause Society Annual Meeting, according to a Depomed media release.
    • 24 Sep 2011 Results assessing outcomes on the Pittsburgh Sleep Quality Index presented at the 22nd Annual Meeting of the North American Menopause Society.
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