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

Phase 3 Completed 600 enrolled Depomed

RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start: 2010-08
Primary completion: 2011-09
Completion: 2011-09

Publications

Pinkerton JV, Kagan R, Portman D, Sathyanarayana R, Sweeney M; Breeze 3 Investigators. Phase 3 randomized controlled study of gastroretentive gabapentin for the treatment of moderate-to-severe hot flashes in menopause. Menopause. 2014 Jun;21(6):567-73. doi: 10.1097/GME.0b013e3182a7c073.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gabapentin	Small molecule	1800 mg	—

Indications

No indication recorded.