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Phase Iii, Randomized, Double-Blind, Placebo-Controlled Evaluation Of Pregabalin For Alleviating Hot Flashes, N07c1, Charles L. Loprinzi, Rui Qin, Ernie P. Baclueva, Donald J. Jurgens
Phase Iii, Randomized, Double-Blind, Placebo-Controlled Evaluation Of Pregabalin For Alleviating Hot Flashes, N07c1, Charles L. Loprinzi, Rui Qin, Ernie P. Baclueva, Donald J. Jurgens
Articles
PURPOSE:
Hot flashes are a common problem for which effective and safe treatments are needed. The current trial was conducted on the basis of preliminary promising data that pregabalin decreased hot flashes.
PATIENTS AND METHODS:
A double-blind, placebo-controlled, randomized trial design was used to compare pregabalin at target doses of 75 mg twice daily and 150 mg twice daily with a placebo. Hot flash frequencies and scores (frequency times mean severity) were recorded daily during a baseline week and for six treatment weeks. The primary end point for this study was the change-from-baseline hot flash score during treatment week 6 …